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    [primary_issue_slug] => 2019-01-01
    [author_name] => {"name":"Sam Brusco","title":"Associate Editor"}
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    [title] => Neurostim Tech Leads the Charge at CES
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    [slug] => neurostim-tech-leads-the-charge-at-ces
    [body] => With 4,500 exhibiting companies and over 180,000 attendees, the Consumer Electronics Show (CES) is considered to be the world’s gathering place for consumer technology businesses and enthusiasts. The forum has been a proving ground of sorts for 50 years—a global stage where next-generation technologies are introduced to the market.

And as healthcare costs in the U.S. soar inexorably upward, CES has also become a setting for devices that allow consumers to become more proactive in their health without breaking the bank. Health technologies have comprised a significant portion of the show for years, and the amount of consumer health technologies making their debut or being showcased have increased dramatically in recent years. And this year, devices that operate using therapeutic neurostimulation made a strong showing in Las Vegas.

For example, Tivic Health’s ClearUP Sinus Pain Relief is a bioelectric treatment for sinus pain brought on by allergic rhinitis, more commonly known as hay fever. The over-the-counter, handheld device achieved FDA 510(k) clearance the week before CES began, and received two awards at this year’s event—the Best of CES from Gear Diary and Top Picks of CES from Techlicious.

The simple, non-invasive, drug-free option relieved three of four patients’ sinus pain in just five minutes during its pivotal trial to obtain the FDA nod. Users need only glide ClearUP along the cheek, nose, and brow bone to apply low current electrical waveforms that stimulate the nerves under the skin to help relieve sinus pain.

“There were a number of CES attendees suffering from allergies who administered a full treatment,” commented Subinoy Das, M.D., and CEO, U.S. Institute for Advanced Sinus Care and Research. “As a clinician, I was pleased to see immediate results in improving breathing and relieving their sinus pain in just five minutes.”

Right now ClearUP is only intended for adults and can be used when needed up to four times a day. It’s reusable and rechargeable, making the device accessible at work, home, or while traveling. The device is a welcome change for sinus sufferers concerned about taking sinus medicine and its side effects—according to Tivic Health’s survey of 600 sinus pain patients, 95 percent wished to reduce the number of medications they were taking, and 91 percent were concerned about the side effects of their current treatments.

InControl Medical’s Attain device targets the approximately 87 million people in the U.S. struggling with stress, urge, or mixed urinary incontinence and/or bowel incontinence. Products to treat incontinence are not something that generally excites the average consumer, but InControl was certainly enthusiastic about showing off its device, which the company claims is the most advanced incontinence control device that is available over the counter. Attain applies electrical stimulation at specific frequencies in an alternating manner to boost pelvic floor muscle strength. The full, deep pelvic floor muscle contraction Attain provokes is a form of neuromuscular retraining.

This treatment is supplemented by visual biofeedback. Attain generates a lighted biofeedback graph, encouraging users to contract their pelvic floor muscles slowly, maintain the lights, and release at the end of the timer. Visual cues guide the patient through a series of variable timed, voluntary contractions along with a relaxation phase, much like a physical therapy session.

Attain’s probe is customizable as well. When inflated to the “comfortably snug” setting, the stimulation contacts are in full contact with the vaginal or rectal wall. The probe provides active resistance for pelvic floor muscles to contract against, then repositions the musculature between contractions, avoiding the problems of a tonic contraction.

“Attain provides muscle stimulation, visual biofeedback, and a guided exercise program to solve incontinence at the source—the muscle level,” said Herschel “Buzz” Peddicord, InControl’s founder and CEO. “Attain’s regular self-treatment program, in the privacy of one’s home, eliminates the need for pads, meds, surgery, or diapers.”

FDA clearance for Attain is currently pending.

Oska Wellness’ Pulse drug-free pain relief device addresses the growing chronic pain and subsequent opioid abuse epidemic problem in the U.S. Oska Pulse has been clinically proven to reduce inflammation, increase circulation, improve mobility, and alleviate pain, thanks to pulsed electromagnetic field (PEMF) technology. PEMF therapy helps the body reduce and recover from inflammation at the cellular level. As Oska Wellness describes it, “PEMF restores the positive and negative charges in the cell, enabling it to perform its natural function while speeding tissue recovery.”

“Chronic pain disrupts the lives of over 100 million Americans daily and is the leading cause of long-term disability in the U.S., affecting more people than diabetes, heart disease, and cancer combined,” said Oska Wellness founder Greg Houlgate. “It’s very clear that the United States is fighting a battle with pain. Oska Pulse addresses this issue at the source and brings affordable, drug-free pain relief to those who need it most.”

Oska Pulse is wearable, portable, and shareable and can fit into virtually any lifestyle. PEMF technology is already used in doctors’ offices worldwide and has been demonstrated in thousands of clinical studies to effectively relieve pain, but Oska Pulse is the first device to be available at an accessible price for home use.  [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2019-01-30 10:34:24 [updated_at] => 2019-01-30 10:34:24 [last_updated_author] => 195666 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["305475","305643","305426","305137","306356","305612","305313","305056","304107","303430","303306","302016","300334"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 [contentType] => ContentType Object ( [className] => ContentType [content] => Array ( ) [taxonomy] => Array ( ) [listURL] => [logoUrl] => https: [id] => 2490 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => content_types [tag] => columns [short_tag] => columns [class_name] => [display_view] => [list_view] => [slug] => columns [box_view] => [ignore_flag] => 0 [image_id] => 0 [layout_id] => 0 [formattedTag] => Columns ) [viewURL] => /issues/2019-01-01/view_columns/neurostim-tech-leads-the-charge-at-ces/ [relatedArticles] => Array ( [0] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 300334 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"U.S. Food and Drug Administration","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 176324 [primary_image_old] => [slider_image_id] => 176324 [banner_image] => 0 [title] => FDA and DHS Begin Partnership to Address Medical Device Cybersecurity Threats [short_title] => [summary] => Under the agreement, DHS will continue to serve as the central medical device vulnerability coordination center. [slug] => fda-and-dhs-begin-partnership-to-address-medical-device-cybersecurity-threats [body] => As part of the Administration’s ongoing efforts to strengthen cybersecurity in healthcare, the U.S. Food and Drug Administration and the U.S. Department of Homeland Security (DHS) announced a memorandum of agreement to implement a new framework for greater coordination and cooperation between the two agencies for addressing cybersecurity in medical devices.
 
“As innovation in medical devices advances and more devices are connected to hospital networks or to other devices, ensuring that devices are adequately protected against cyber intrusions is paramount to protecting patients. The FDA has been proactive in developing a robust program to address medical device cybersecurity concerns,” said FDA Commissioner Scott Gottlieb, M.D. “But we also know that securing medical devices from cybersecurity threats cannot be achieved by one government agency alone. Every stakeholder has a unique role to play in addressing these modern challenges. That’s why this announcement is so important. Our strengthened partnership with DHS will help our two agencies share information and better collaborate to stay a step ahead of constantly evolving medical device cybersecurity vulnerabilities and assist the healthcare sector in being well positioned to proactively respond when cyber vulnerabilities are identified. This agreement demonstrates our commitment to confronting cybersecurity risks and the unscrupulous cybercriminals who may seek to put patient lives at risk.”
 
“Ensuring our ability to identify, address and mitigate vulnerabilities in medical devices is a top priority, which is why DHS depends on our important partnership with the FDA to collaborate and provide actionable information. This agreement is another important step in our collaboration,” said Christopher Krebs, Undersecretary for the National Protection and Programs Directorate at DHS. “DHS has some of the top experts on control systems technology, and we look forward to continuing to leverage this expertise for the sake of improving the lives and safety of people across the country. DHS has enjoyed a great working relationship with the FDA for several years and look forward to this agreement making that working relationship even stronger and more effective.”
 
The agreement, between the FDA’s Center for Devices and Radiological Health and DHS’ Office of Cybersecurity and Communications, is meant to encourage even greater coordination and information sharing about potential or confirmed medical device cybersecurity vulnerabilities and threats. Such collaboration can lead to more timely and better responses to potential threats to patient safety.
 
The two agencies have already worked together on many aspects of medical device cybersecurity, most notably around coordination of vulnerability disclosures. This helps medical device manufacturers receive technical information from cybersecurity researchers regarding identified vulnerabilities in their products in a way that enables all parties to respond to potential threats in a timely way. The agencies have also collaborated on planning, executing and conducting after-action reviews of DHS-led exercises that simulate real-world cybersecurity attacks and enable the government and stakeholders to practice and improve their responses to these threats. The goal of the agreement is to expand these types of collaboration by increasing the sharing of information between the two agencies to enhance mutual awareness of potential or known threats, thereby heightening coordination when vulnerabilities are identified. And to enhance shared technical capabilities, such as conducting collaborative assessments regarding the level of risk a potential vulnerability may pose to patient safety and coordinate testing of devices as warranted.
 
Under the agreement, DHS will continue to serve as the central medical device vulnerability coordination center and interface with appropriate stakeholders, including consulting with the FDA for technical and clinical expertise regarding medical devices. The DHS’ National Cybersecurity and Communications Integration Center will continue to coordinate and enable information sharing between medical device manufacturers, researchers and the FDA, particularly in the event of cybersecurity vulnerabilities in medical devices that are identified to the Department of Homeland Security. The FDA will continue to engage in regular, ad hoc, and emergency coordination calls with DHS and advise DHS regarding the risk to patient health and potential for harm posed by identified cybersecurity threats and vulnerabilities.
 
The agreement formalizes a long-standing relationship between the FDA and DHS. Through this agreement, both agencies are renewing their commitment to working with not only each other, but also all stakeholders to create an environment of shared responsibility when it comes to coordinated vulnerability disclosure for identifying and addressing cybersecurity risks. This kind of coordination and information sharing can ultimately help protect patients who rely on lifesaving medical devices. 
 
The FDA promotes and protects the public health by ensuring the safety, efficacy, and security of medical products, including medical devices. The agency has taken significant steps to create an environment of shared responsibility between government agencies, industry, healthcare delivery organizations, and cybersecurity researchers. Interconnected devices increase cybersecurity risks which, if exploited, may affect device performance. The agency is committed to enhancing patient safety by mitigating cybersecurity risk throughout the life cycle of medical devices, which includes monitoring, identifying and addressing cybersecurity vulnerabilities in medical devices once they are on the market. 
 
The DHS mission includes preventing terrorism and enhancing security; managing U.S. borders; administering immigration laws; securing cyberspace; and ensuring disaster resilience. Information sharing is a critical part of the DHS mission to create shared situational awareness of malicious cyber activity. DHS works to prevent or minimize disruptions to critical information infrastructure in order to protect the public, the economy, and government services. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-10-17 10:27:00 [updated_at] => 2018-10-17 10:37:49 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["279504","282390","284256","283867","294745","299278","297561","292699","280635","300250","299761","299382","298924","297183","296568","296302","296232"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [1] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 302016 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Scott Gottlieb, M.D.","title":"Commissioner, U.S. Food and Drug Administration"} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 177694 [primary_image_old] => [slider_image_id] => 177694 [banner_image] => 0 [title] => New Efforts to Strengthen FDA’s Expanded Access Program [short_title] => [summary] => EA provides a pathway for patients to gain access to investigational drugs, biologics, and medical devices. [slug] => new-efforts-to-strengthen-fdas-expanded-access-program [body] => Since the 1970s, the FDA has helped to facilitate access to promising investigational medical products for patients with serious or immediately life-threatening diseases who are unable to access products through clinical trials. As a cancer survivor, I understand, on a very personal level, that patients who are fighting serious or life-threatening diseases want the flexibility to try new therapeutic approaches, including investigational medical products. This is especially relevant when there’s no other FDA-approved treatment option available to a patient.
 
FDA is deeply committed to facilitating this access, while also protecting patients and helping them to be able to make informed decisions with their physicians. We also take steps to help make sure that such access doesn’t interfere or jeopardize investigational trials that could support a medical product’s development or timely approval for the treatment indication.
 
This is the mission of our Expanded Access (EA) program. EA provides a pathway for patients to gain access to investigational drugs, biologics, and medical devices for serious diseases and immediately life-threatening conditions outside of clinical trials when no comparable or satisfactory approved alternative therapy options are available. We’re taking new steps to improve this framework.
 
Over the last five years, FDA has authorized more than 9,000 applications across drugs, biologics, and devices through the agency’s expanded access program. Furthermore, we’ve authorized approximately 99 percent of all the requests we have received, across all application types.
 
FDA staff is deeply committed to this program and ensuring that it works quickly and effectively for patients and their physicians. Emergency requests for individual patients are usually granted immediately by phone. Non-emergency requests are generally processed within a few days.
 
Despite the success of the EA program, we recognize that there are opportunities for improvement. We’ve taken steps to expand and update the program over the last year. Many of these changes were made in response to feedback the agency received from stakeholders, as well as input from Congress, on how we can make the program more effective.
 
One improvement FDA made was streamlining the required supporting documentation for expanded access requests submitted by a physician for access to a drug or biological for the treatment of an individual patient. These changes reduced the administrative burden for these physicians. Following these changes, we estimate that it takes about 45 minutes, on average, to complete a patient application form. That form typically requires just one attachment.
 
We also simplified the process for Institutional Review Board (IRB) review. For single patient EA, we’ve modified the IRB review process to permit just one IRB member – the chair or another appropriate person – to concur with the treatment use rather than the entire Board.
 
We also clarified in guidance how we use safety data generated from using an investigational drug or biologic through the EA pathway, recognizing and addressing companies’ concerns that EA-related adverse event data could be used in ways that complicate the review process.
 
As part of FDA’s commitment to continuous operational improvement of the expanded access program, we announced last year that we commissioned an independent assessment of the program. The goals were to better understand the current EA program’s performance and identify ways to improve it. It considered stakeholder perspectives from across the healthcare ecosystem, including patients and their advocates/caregivers, healthcare providers and the health systems that support healthcare providers, payers, IRBs, manufacturers, and FDA staff.
 
I’d like to highlight some of the key findings from this assessment, and how we are addressing the opportunities that we’ve identified as ways to strengthen the expanded access program.
The assessment found overall support for FDA’s program, but as we hoped in pursuing this analysis, also identified new steps we can take to improve upon our efforts.
 
For example, the assessment found that external stakeholders’ overall perceptions of FDA’s expanded access program—and FDA’s role in administering it—are very positive. Stakeholders across the health care system highlighted FDA’s commitment to expediting the review of EA applications, the FDA’s collaborative nature, and our focus on continuous improvement.
 
Physicians with direct experience submitting an EA application to the FDA reported positive impressions of the program. Similarly, patients and their advocates described the program as a crucial route to access investigational therapies when other alternatives have been exhausted.
 
Manufacturers, patient advocates, IRB representatives, and physicians all noted that FDA has taken key steps to reduce the administrative burden associated with submitting requests and recognized our commitment to facilitating medically appropriate access via the EA program.
 
Stakeholders also reported some challenges across the physician and patient journey through the program, that, if properly addressed, could meaningfully enhance the program. This feedback is crucial in our continued efforts to improve the program.
 
We’re already acting on these findings.
 
For one thing, the assessment found that confusion with program navigation, multi-stakeholder coordination, and administrative burden were the most frequently-cited challenges. The assessment recommendations include improving FDA’s public website content and investing in resources to support patient/physician program navigation. These are areas where we’ve already taken steps to improve the program, or where we are working on improvements.
 
For instance, based on the feedback from the assessment, today we announced that FDA’s EA webpages will be updated to improve usability through streamlining of content and a more user-friendly organization. This includes a reduction in duplication, as well as the addition of new pages with commonly requested information, such as forms and keywords.
 
These updates will begin rolling out today and will continue in the future as we identify new opportunities to improve the usability of information on our EA webpages.
 
As part of our recently announced proposed reorganization of the Office of the Commissioner, we intend to formally establish an agency-wide Patient Affairs Staff and Health Care Provider Affairs Program, under the oversight of the Office of Clinical Policy and Programs. This will enhance our engagement with these important external stakeholder groups. The Patient Affairs Staff is already in place and charged with serving as the “home base” and primary point of entry for patients and physicians starting the EA process and navigating them through the steps.
 
Additionally, we’ve established an agency-wide Expanded Access Coordinating Committee, which facilitates cross-Center communication and promotes discussion to rapidly address cross-cutting issues related to expanded access to promote consistency and best practices.
 
FDA is deeply committed to our Expanded Access program and facilitating access to medical products outside of clinical trials when no alternative therapy options are available to patients. And we are deeply committed to continuing to enhance this program going forward.
 
It’s important to note that while expanded access represents FDA’s primary avenue for facilitating access for certain patients to unapproved, investigational treatments, the “Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017,” recently signed into law by the President, represents a separate and distinct pathway. The FDA has established a work group to consider what steps may be required to implement this legislation in a way that advances Congress’ intent to promote access and protect patients. Any work we undertake will build on our long-standing commitments to help patients facing life-threatening diseases or conditions access investigational medicines. As a first step, today we are launching a Right to Try webpage that will assist patients in understanding this alternative pathway.
 
We’re dedicated to making sure that patients facing serious conditions have access to promising investigational medicines. We will continue to take new steps to advance these goals. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-11-09 09:23:00 [updated_at] => 2018-11-09 09:26:56 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["300334","300250","299761","299382","298924","297561","297183","296568","296302","296232","299794","282390","299952","289377","290458","281299","289752","280635","289768"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [2] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 303306 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"U.S. Food and Drug Administration","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 178856 [primary_image_old] => [slider_image_id] => 178856 [banner_image] => 0 [title] => FDA Green Lights First Test to Help Detect Cytomegalovirus in Newborns [short_title] => [summary] => Although not typically a risk, the herpes virus can potentially cause serious illness in newborn babies. [slug] => fda-green-lights-first-test-to-help-detect-cytomegalovirus-in-newborns [body] => The U.S. Food and Drug Administration permitted marketing of a new diagnostic test to aid in detecting a type of herpes virus called cytomegalovirus (CMV) in newborns less than 21 days of age.
 
“Although most people who become infected with cytomegalovirus face little to no risk of serious illness, the virus has the potential to cause serious illness for people with weak immune systems and in newborn babies,” said Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “This test for detecting the virus, when used in conjunction with the results of other diagnostic tests, may help health care providers more quickly identify the virus in newborns and determine the best approach for the child.”
 
According to the Centers for Disease Control and Prevention, more than half of adults by age 40 have been infected with CMV. Most people infected with CMV show no signs or symptoms of infection. However, CMV infection can cause serious health problems for people with weakened immune systems and for some newborns. Congenital CMV occurs when a baby is infected with CMV during pregnancy. Although most babies with CMV will not have any signs or symptoms of infection, some babies can develop hearing problems or other long-term health problems.
 
The Alethia CMV Assay Test System is used as an aid in the diagnosis of congenital CMV infection by detecting CMV deoxyribonucleic acid (DNA) from a saliva swab. Test results should be used only in conjunction with the results of other diagnostic tests and clinical information.
 
The FDA evaluated the analytical and clinical performance of the device. Data from a prospective clinical study showed that 1,472 saliva samples out of 1,475 samples collected from newborns were correctly identified by the device as negative for the presence of CMV DNA. Three samples were incorrectly identified as positive when they were negative. Five collected saliva specimens were correctly identified as positive for the presence of CMV DNA. The FDA also reviewed data from a testing of 34 samples of archived specimens from babies known to be infected with CMV in which all the archived specimens were correctly identified by the device as positive for presence of CMV DNA.
 
The FDA reviewed the Alethia CMV Assay Test System through the de novo premarket review pathway, a regulatory pathway for novel, low-to-moderate-risk devices of a new type. Along with this authorization, the FDA is establishing criteria, called special controls, which determines the requirements for demonstrating accuracy, reliability, and effectiveness of tests intended to be used as an aid in the diagnosis of congenital CMV infection. These special controls, when met along with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type.
 
This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.
 
The FDA granted marketing authorization of the Alethia CMV Assay Test System to Meridian Bioscience Inc. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-12-03 09:07:00 [updated_at] => 2018-12-03 09:13:27 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["302016","300334","300250","299761","299382","298924","297561","297183","296568","296302","287716","285017","297010","288422","290992","283698","292170","291998","292980","301664"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [3] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 303430 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2720 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Sean Fenske","title":"Editor-in-Chief"} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 179033 [primary_image_old] => [slider_image_id] => 0 [banner_image] => 0 [title] => Mike on Medtech: Holiday Wish List, Part 1 [short_title] => [summary] => Sean Fenske and Mike Drues share their thoughts on what the industry might be looking for in the coming year. [slug] => mike-on-medtech-holiday-wish-list-part-1 [body] => In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss my lastest Editor’s Letter that appeared in the November/December issue of MPO, My Holiday Wish List (for Industry) (click here to read that Letter). In this Letter, I outlined a few things that I would like to see for the benefit of the medical device industry. The items included an improved image for the industry, pain management technologies market success, reform or improvment in reimbursement and CMS, and a couple other items. In part 1 of this two-part podcast series, we address the first item, an improved image, and discuss the recent "black eyes" suffered by the medtech industry, such as The Bleeding Edge documentary and an investative report that cited dangerous medical devices. We also discuss announced changes the FDA intends to introduce such as the 510k Modernization effort.

Listen to this episode and see what you think regarding the my holiday wish list. What did I leave off that should have been included? What's on your personal list? If you’d like to share thoughts and comments with us or have questions on the topic, please reach out to me with them at sfenske@rodmanmedia.com so I can perhaps discuss them with Mike in an upcoming episode.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.

You can check out the second part of this podcast series by clicking here.

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[views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-12-04 09:56:00 [updated_at] => 2019-08-15 15:28:28 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => {"video_url":{"video_url":"Video URL","value":"https://players.brightcove.net/73033050001/default_default/index.html?videoId=5975338454001"},"image_url":{"image_url":"Image URL","value":"http://rodpub.com/email/mpo/images/1400x1400.jpg"},"video_id":{"video_id":"Video ID","value":"5975338454001"}} [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["320011","319679","319180","318935","318889","318858","318706","317769","317622","316570","316351","316297","315502","315274","315263","311437","311395","310103","309296"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [4] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 304107 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"U.S. Department of Justice","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 179478 [primary_image_old] => [slider_image_id] => 179478 [banner_image] => 0 [title] => Olympus Fined $85M in Endoscope Case; Former Executive Faces Jail Time [short_title] => [summary] => Olympus admitted that it failed to file with the FDA required adverse event reports in 2012 and 2013 relating to three separate infection events. [slug] => olympus-fined-85m-in-endoscope-case-former-executive-faces-jail-time [body] => Olympus Medical Systems Corporation and a former senior executive in Japan pleaded guilty in Newark, N.J., to failing to file required adverse event reports involving infections connected to duodenoscopes, and continuing to sell the duodenoscopes in the United States despite those failures, the Justice Department announced.
 
Olympus, which is located in Tokyo, Japan, and Hisao Yabe, 62, of Japan, both entered guilty pleas before U.S. District Court Judge Stanley R. Chesler in Newark Federal Court: Olympus to three counts, and Yabe to one count, of distributing misbranded medical devices in interstate commerce in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). 
 
Judge Chesler also imposed sentence on the company—fining Olympus $80,000,000 and ordering $5,000,000 in criminal forfeiture, consistent with a plea agreement between Olympus and the Justice Department. Olympus must also abide by an agreement with the Justice Department requiring Olympus to enact extensive compliance reforms.
 
Yabe is scheduled to be sentenced by Judge Chesler on March 27, 2019. Yabe faces a maximum potential penalty of a year in prison and a $100,000 fine, or twice the gain or loss from the offense.
 
Olympus admitted that it failed to file with the Food and Drug Administration (FDA) required adverse event reports in 2012 and 2013 relating to three separate events involving infections in Europe connected to Olympus’s TJF-Q180V duodenoscope (Q180V): the infection of approximately 22 patients with Pseudomonas aeruginosa at the Erasmus Medical Center in the Netherlands in early 2012; the infection of three patients with Escherichia coli at Clinique de Bercy in France in November 2012; and the infection of five patients with Pseudomonas aeruginosa at Kremlin Bicetre in France in July 2012.
 
Yabe admitted his own personal responsibility for the failure to file the necessary information with FDA relating to the Erasmus Medical Center infections. At the time, Yabe was Olympus’s Division Manager for the Quality and Environment Division—Olympus’s top regulatory official, whose responsibilities included adverse event reporting in the United States. 
 
“Medical devices, such as the Olympus duodenoscope that is used in 500,000 procedures per year in the United States, can extend and improve the quality of life for many people,” said Assistant Attorney General Jody Hunt for the Department of Justice’s Civil Division. “But when a device manufacturer becomes aware of risks that could lead to illness, injury, or death, there is a statutory obligation to report that information to the FDA in a timely manner. By failing to do so, Olympus and Mr. Yabe put patients’ health at risk.”
 
“Olympus and Yabe failed to file important FDA reports regarding adverse events,” Attorney for the United States Rachael Honig, District of New Jersey, said. “It is especially troubling that they remained quiet when they received additional information from an independent expert questioning the safety of Olympus’ device. Patient safety must always be a paramount concern for medical device companies, and these defendants simply failed to treat that concern with the gravity it deserves. The resolution is a reminder that this office will act whenever patient safety is put at risk by a quest for profits.”
 
“Medical device adverse event reporting requirements are designed to protect Americans by providing FDA with a tool to detect potential safety issues. When device manufacturers fail to report adverse events, unsuspecting patients are placed at risk,” said FDA Commissioner Scott Gottlieb, M.D. “We take our patient safety mission very seriously and we remain fully committed to aggressively pursuing those who jeopardize public health by subverting FDA’s regulatory requirements.”
 
Olympus’s and Yabe’s Failure to File Required Adverse Event Reports
To enable FDA and others to identify and monitor adverse events, the FDCA requires medical device manufacturers to file adverse event reports—known as Medical Device Reports (MDRs)—when the manufacturer becomes aware of information that reasonably suggests that the manufacturer’s device may have caused or contributed to a death or serious injury. The FDCA also requires manufacturers to file supplemental MDRs if they subsequently obtain information about the event that was not known or available when the initial MDR was filed.
 
Olympus admitted that it failed to make the required initial MDR filing regarding the Kremlin Bicetre infections, and failed to file required supplemental MDRs relating to the Erasmus Medical Center and Clinique de Bercy infections, for which Olympus had filed initial MDRs. Under the FDCA, devices for which required MDRs and supplemental MDRs have not been filed are deemed misbranded, and it is a crime to ship such devices in interstate commerce. Between August 2012 and October 2014, Olympus shipped hundreds of misbranded duodenoscopes in the United States, generating approximately $40 million in revenue and approximately $33 million in total gross profit. Olympus’s payment of $85 million is more than 2½ times Olympus’s total profit from sales of the misbranded duodenoscopes.
 
Yabe admitted that he was aware of Olympus’s obligation to file supplemental MDRs and was involved in Olympus’s failure to file a supplemental MDR regarding the Erasmus Medical Center infections and a report Olympus received prepared by an independent expert of Delft University of Technology in the Netherlands. That expert report—which Olympus obtained in the summer of 2012—noted numerous problems with the Q180V, including that the Q180V’s tip had various cracks, corners, and crevices that could harbor bacteria and could be cleaned only with great difficulty. The report recommended immediate further investigation of all such scopes, updating the cleaning instructions, and improving the quality of the seals.
 
Additional Compliance Measures
As part of its plea agreement with the Justice Department, Olympus has agreed to: retain an independent MDR expert to inspect and review Olympus’s policies and procedures to determine their compliance with the MDR requirements of the FDCA and its implementing regulations; periodic review by the MDR expert of Olympus’s continued compliance with the MDR requirements of the FDCA and its implementing regulations; and conduct a review and audit of the device classification and market pathway for all endoscope device types manufactured by Olympus that are intended for use in the sterile body cavity and that are currently sold in the United States. The MDR expert will report back to FDA and the Justice Department periodically for three years. In addition, the President of Olympus and Olympus’s Board of Directors will periodically conduct a review of Olympus’s MDR compliance measures and classification/marketing pathway review and provide certifications to FDA and the Justice Department relating to those reviews. Olympus also is obligated to inform health care providers in the United States who received Q180Vs between August 2012 and October 2014 of Olympus’s plea, and to provide information to those health care providers regarding Olympus’s failure to file the required MDRs.
 
In March 2016, Olympus Corp. of the Americas and Olympus Latin America, two separate subsidiaries of Olympus Corp., entered into deferred prosecution agreements (DPAs) and civil settlements with the U.S. Attorney’s Office for the District of New Jersey and the Justice Department’s Civil Division to resolve criminal and civil charges and civil claims relating to schemes between 2006-2011 to pay kickbacks to doctors and hospitals in the United States and violate the Foreign Corrupt Practices Act in Latin America. The DPAs are scheduled to expire in March 2019. While the unlawful conduct at issue in the resolution terminated in October 2014—a year and a half before the government entered into the DPAs—conduct relating to violations of the FDCA and failure to file MDRs was specifically not covered by the March 2016 resolution, as the investigation into the FDCA violations was ongoing at that time.
 
The guilty pleas are the culmination of an investigation conducted by special agents from FDA’s Office of Criminal Investigations, under the direction of Special Agent in Charge Jeffrey J. Ebersole of the New York Field Office, along with special agents from the U.S. Department of Health and Human Services, Office of Inspector General, under the direction of Special Agent in Charge Scott J. Lampert, and special agents of the FBI, under the direction of Special Agent in Charge Gregory W. Ehrie.
 
The government is represented in the criminal case by Assistant U.S. Attorneys Jacob T. Elberg and R. David Walk, Jr. of the U.S. Attorney’s Office’s Health Care and Government Fraud Unit, and Senior Litigation Counsel Patrick Jasperse of the Justice Department’s Consumer Protection Branch, with the assistance of Senior Counsel Shannon M. Singleton of the FDA’s Office of Chief Counsel. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-12-11 14:19:00 [updated_at] => 2018-12-11 14:29:48 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["300573","299654","303316","289756","289787","290022","302199","299086","304100","284256","283867","302883","294745","299278","300334","297561","292699","289790"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) ) [relatedContent] => Array ( [0] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 300334 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"U.S. Food and Drug Administration","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 176324 [primary_image_old] => [slider_image_id] => 176324 [banner_image] => 0 [title] => FDA and DHS Begin Partnership to Address Medical Device Cybersecurity Threats [short_title] => [summary] => Under the agreement, DHS will continue to serve as the central medical device vulnerability coordination center. [slug] => fda-and-dhs-begin-partnership-to-address-medical-device-cybersecurity-threats [body] => As part of the Administration’s ongoing efforts to strengthen cybersecurity in healthcare, the U.S. Food and Drug Administration and the U.S. Department of Homeland Security (DHS) announced a memorandum of agreement to implement a new framework for greater coordination and cooperation between the two agencies for addressing cybersecurity in medical devices.
 
“As innovation in medical devices advances and more devices are connected to hospital networks or to other devices, ensuring that devices are adequately protected against cyber intrusions is paramount to protecting patients. The FDA has been proactive in developing a robust program to address medical device cybersecurity concerns,” said FDA Commissioner Scott Gottlieb, M.D. “But we also know that securing medical devices from cybersecurity threats cannot be achieved by one government agency alone. Every stakeholder has a unique role to play in addressing these modern challenges. That’s why this announcement is so important. Our strengthened partnership with DHS will help our two agencies share information and better collaborate to stay a step ahead of constantly evolving medical device cybersecurity vulnerabilities and assist the healthcare sector in being well positioned to proactively respond when cyber vulnerabilities are identified. This agreement demonstrates our commitment to confronting cybersecurity risks and the unscrupulous cybercriminals who may seek to put patient lives at risk.”
 
“Ensuring our ability to identify, address and mitigate vulnerabilities in medical devices is a top priority, which is why DHS depends on our important partnership with the FDA to collaborate and provide actionable information. This agreement is another important step in our collaboration,” said Christopher Krebs, Undersecretary for the National Protection and Programs Directorate at DHS. “DHS has some of the top experts on control systems technology, and we look forward to continuing to leverage this expertise for the sake of improving the lives and safety of people across the country. DHS has enjoyed a great working relationship with the FDA for several years and look forward to this agreement making that working relationship even stronger and more effective.”
 
The agreement, between the FDA’s Center for Devices and Radiological Health and DHS’ Office of Cybersecurity and Communications, is meant to encourage even greater coordination and information sharing about potential or confirmed medical device cybersecurity vulnerabilities and threats. Such collaboration can lead to more timely and better responses to potential threats to patient safety.
 
The two agencies have already worked together on many aspects of medical device cybersecurity, most notably around coordination of vulnerability disclosures. This helps medical device manufacturers receive technical information from cybersecurity researchers regarding identified vulnerabilities in their products in a way that enables all parties to respond to potential threats in a timely way. The agencies have also collaborated on planning, executing and conducting after-action reviews of DHS-led exercises that simulate real-world cybersecurity attacks and enable the government and stakeholders to practice and improve their responses to these threats. The goal of the agreement is to expand these types of collaboration by increasing the sharing of information between the two agencies to enhance mutual awareness of potential or known threats, thereby heightening coordination when vulnerabilities are identified. And to enhance shared technical capabilities, such as conducting collaborative assessments regarding the level of risk a potential vulnerability may pose to patient safety and coordinate testing of devices as warranted.
 
Under the agreement, DHS will continue to serve as the central medical device vulnerability coordination center and interface with appropriate stakeholders, including consulting with the FDA for technical and clinical expertise regarding medical devices. The DHS’ National Cybersecurity and Communications Integration Center will continue to coordinate and enable information sharing between medical device manufacturers, researchers and the FDA, particularly in the event of cybersecurity vulnerabilities in medical devices that are identified to the Department of Homeland Security. The FDA will continue to engage in regular, ad hoc, and emergency coordination calls with DHS and advise DHS regarding the risk to patient health and potential for harm posed by identified cybersecurity threats and vulnerabilities.
 
The agreement formalizes a long-standing relationship between the FDA and DHS. Through this agreement, both agencies are renewing their commitment to working with not only each other, but also all stakeholders to create an environment of shared responsibility when it comes to coordinated vulnerability disclosure for identifying and addressing cybersecurity risks. This kind of coordination and information sharing can ultimately help protect patients who rely on lifesaving medical devices. 
 
The FDA promotes and protects the public health by ensuring the safety, efficacy, and security of medical products, including medical devices. The agency has taken significant steps to create an environment of shared responsibility between government agencies, industry, healthcare delivery organizations, and cybersecurity researchers. Interconnected devices increase cybersecurity risks which, if exploited, may affect device performance. The agency is committed to enhancing patient safety by mitigating cybersecurity risk throughout the life cycle of medical devices, which includes monitoring, identifying and addressing cybersecurity vulnerabilities in medical devices once they are on the market. 
 
The DHS mission includes preventing terrorism and enhancing security; managing U.S. borders; administering immigration laws; securing cyberspace; and ensuring disaster resilience. Information sharing is a critical part of the DHS mission to create shared situational awareness of malicious cyber activity. DHS works to prevent or minimize disruptions to critical information infrastructure in order to protect the public, the economy, and government services. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-10-17 10:27:00 [updated_at] => 2018-10-17 10:37:49 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["279504","282390","284256","283867","294745","299278","297561","292699","280635","300250","299761","299382","298924","297183","296568","296302","296232"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [1] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 302016 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Scott Gottlieb, M.D.","title":"Commissioner, U.S. Food and Drug Administration"} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 177694 [primary_image_old] => [slider_image_id] => 177694 [banner_image] => 0 [title] => New Efforts to Strengthen FDA’s Expanded Access Program [short_title] => [summary] => EA provides a pathway for patients to gain access to investigational drugs, biologics, and medical devices. [slug] => new-efforts-to-strengthen-fdas-expanded-access-program [body] => Since the 1970s, the FDA has helped to facilitate access to promising investigational medical products for patients with serious or immediately life-threatening diseases who are unable to access products through clinical trials. As a cancer survivor, I understand, on a very personal level, that patients who are fighting serious or life-threatening diseases want the flexibility to try new therapeutic approaches, including investigational medical products. This is especially relevant when there’s no other FDA-approved treatment option available to a patient.
 
FDA is deeply committed to facilitating this access, while also protecting patients and helping them to be able to make informed decisions with their physicians. We also take steps to help make sure that such access doesn’t interfere or jeopardize investigational trials that could support a medical product’s development or timely approval for the treatment indication.
 
This is the mission of our Expanded Access (EA) program. EA provides a pathway for patients to gain access to investigational drugs, biologics, and medical devices for serious diseases and immediately life-threatening conditions outside of clinical trials when no comparable or satisfactory approved alternative therapy options are available. We’re taking new steps to improve this framework.
 
Over the last five years, FDA has authorized more than 9,000 applications across drugs, biologics, and devices through the agency’s expanded access program. Furthermore, we’ve authorized approximately 99 percent of all the requests we have received, across all application types.
 
FDA staff is deeply committed to this program and ensuring that it works quickly and effectively for patients and their physicians. Emergency requests for individual patients are usually granted immediately by phone. Non-emergency requests are generally processed within a few days.
 
Despite the success of the EA program, we recognize that there are opportunities for improvement. We’ve taken steps to expand and update the program over the last year. Many of these changes were made in response to feedback the agency received from stakeholders, as well as input from Congress, on how we can make the program more effective.
 
One improvement FDA made was streamlining the required supporting documentation for expanded access requests submitted by a physician for access to a drug or biological for the treatment of an individual patient. These changes reduced the administrative burden for these physicians. Following these changes, we estimate that it takes about 45 minutes, on average, to complete a patient application form. That form typically requires just one attachment.
 
We also simplified the process for Institutional Review Board (IRB) review. For single patient EA, we’ve modified the IRB review process to permit just one IRB member – the chair or another appropriate person – to concur with the treatment use rather than the entire Board.
 
We also clarified in guidance how we use safety data generated from using an investigational drug or biologic through the EA pathway, recognizing and addressing companies’ concerns that EA-related adverse event data could be used in ways that complicate the review process.
 
As part of FDA’s commitment to continuous operational improvement of the expanded access program, we announced last year that we commissioned an independent assessment of the program. The goals were to better understand the current EA program’s performance and identify ways to improve it. It considered stakeholder perspectives from across the healthcare ecosystem, including patients and their advocates/caregivers, healthcare providers and the health systems that support healthcare providers, payers, IRBs, manufacturers, and FDA staff.
 
I’d like to highlight some of the key findings from this assessment, and how we are addressing the opportunities that we’ve identified as ways to strengthen the expanded access program.
The assessment found overall support for FDA’s program, but as we hoped in pursuing this analysis, also identified new steps we can take to improve upon our efforts.
 
For example, the assessment found that external stakeholders’ overall perceptions of FDA’s expanded access program—and FDA’s role in administering it—are very positive. Stakeholders across the health care system highlighted FDA’s commitment to expediting the review of EA applications, the FDA’s collaborative nature, and our focus on continuous improvement.
 
Physicians with direct experience submitting an EA application to the FDA reported positive impressions of the program. Similarly, patients and their advocates described the program as a crucial route to access investigational therapies when other alternatives have been exhausted.
 
Manufacturers, patient advocates, IRB representatives, and physicians all noted that FDA has taken key steps to reduce the administrative burden associated with submitting requests and recognized our commitment to facilitating medically appropriate access via the EA program.
 
Stakeholders also reported some challenges across the physician and patient journey through the program, that, if properly addressed, could meaningfully enhance the program. This feedback is crucial in our continued efforts to improve the program.
 
We’re already acting on these findings.
 
For one thing, the assessment found that confusion with program navigation, multi-stakeholder coordination, and administrative burden were the most frequently-cited challenges. The assessment recommendations include improving FDA’s public website content and investing in resources to support patient/physician program navigation. These are areas where we’ve already taken steps to improve the program, or where we are working on improvements.
 
For instance, based on the feedback from the assessment, today we announced that FDA’s EA webpages will be updated to improve usability through streamlining of content and a more user-friendly organization. This includes a reduction in duplication, as well as the addition of new pages with commonly requested information, such as forms and keywords.
 
These updates will begin rolling out today and will continue in the future as we identify new opportunities to improve the usability of information on our EA webpages.
 
As part of our recently announced proposed reorganization of the Office of the Commissioner, we intend to formally establish an agency-wide Patient Affairs Staff and Health Care Provider Affairs Program, under the oversight of the Office of Clinical Policy and Programs. This will enhance our engagement with these important external stakeholder groups. The Patient Affairs Staff is already in place and charged with serving as the “home base” and primary point of entry for patients and physicians starting the EA process and navigating them through the steps.
 
Additionally, we’ve established an agency-wide Expanded Access Coordinating Committee, which facilitates cross-Center communication and promotes discussion to rapidly address cross-cutting issues related to expanded access to promote consistency and best practices.
 
FDA is deeply committed to our Expanded Access program and facilitating access to medical products outside of clinical trials when no alternative therapy options are available to patients. And we are deeply committed to continuing to enhance this program going forward.
 
It’s important to note that while expanded access represents FDA’s primary avenue for facilitating access for certain patients to unapproved, investigational treatments, the “Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017,” recently signed into law by the President, represents a separate and distinct pathway. The FDA has established a work group to consider what steps may be required to implement this legislation in a way that advances Congress’ intent to promote access and protect patients. Any work we undertake will build on our long-standing commitments to help patients facing life-threatening diseases or conditions access investigational medicines. As a first step, today we are launching a Right to Try webpage that will assist patients in understanding this alternative pathway.
 
We’re dedicated to making sure that patients facing serious conditions have access to promising investigational medicines. We will continue to take new steps to advance these goals. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-11-09 09:23:00 [updated_at] => 2018-11-09 09:26:56 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["300334","300250","299761","299382","298924","297561","297183","296568","296302","296232","299794","282390","299952","289377","290458","281299","289752","280635","289768"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [2] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 303306 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"U.S. Food and Drug Administration","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 178856 [primary_image_old] => [slider_image_id] => 178856 [banner_image] => 0 [title] => FDA Green Lights First Test to Help Detect Cytomegalovirus in Newborns [short_title] => [summary] => Although not typically a risk, the herpes virus can potentially cause serious illness in newborn babies. [slug] => fda-green-lights-first-test-to-help-detect-cytomegalovirus-in-newborns [body] => The U.S. Food and Drug Administration permitted marketing of a new diagnostic test to aid in detecting a type of herpes virus called cytomegalovirus (CMV) in newborns less than 21 days of age.
 
“Although most people who become infected with cytomegalovirus face little to no risk of serious illness, the virus has the potential to cause serious illness for people with weak immune systems and in newborn babies,” said Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “This test for detecting the virus, when used in conjunction with the results of other diagnostic tests, may help health care providers more quickly identify the virus in newborns and determine the best approach for the child.”
 
According to the Centers for Disease Control and Prevention, more than half of adults by age 40 have been infected with CMV. Most people infected with CMV show no signs or symptoms of infection. However, CMV infection can cause serious health problems for people with weakened immune systems and for some newborns. Congenital CMV occurs when a baby is infected with CMV during pregnancy. Although most babies with CMV will not have any signs or symptoms of infection, some babies can develop hearing problems or other long-term health problems.
 
The Alethia CMV Assay Test System is used as an aid in the diagnosis of congenital CMV infection by detecting CMV deoxyribonucleic acid (DNA) from a saliva swab. Test results should be used only in conjunction with the results of other diagnostic tests and clinical information.
 
The FDA evaluated the analytical and clinical performance of the device. Data from a prospective clinical study showed that 1,472 saliva samples out of 1,475 samples collected from newborns were correctly identified by the device as negative for the presence of CMV DNA. Three samples were incorrectly identified as positive when they were negative. Five collected saliva specimens were correctly identified as positive for the presence of CMV DNA. The FDA also reviewed data from a testing of 34 samples of archived specimens from babies known to be infected with CMV in which all the archived specimens were correctly identified by the device as positive for presence of CMV DNA.
 
The FDA reviewed the Alethia CMV Assay Test System through the de novo premarket review pathway, a regulatory pathway for novel, low-to-moderate-risk devices of a new type. Along with this authorization, the FDA is establishing criteria, called special controls, which determines the requirements for demonstrating accuracy, reliability, and effectiveness of tests intended to be used as an aid in the diagnosis of congenital CMV infection. These special controls, when met along with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type.
 
This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.
 
The FDA granted marketing authorization of the Alethia CMV Assay Test System to Meridian Bioscience Inc. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-12-03 09:07:00 [updated_at] => 2018-12-03 09:13:27 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["302016","300334","300250","299761","299382","298924","297561","297183","296568","296302","287716","285017","297010","288422","290992","283698","292170","291998","292980","301664"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [3] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 303430 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2720 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Sean Fenske","title":"Editor-in-Chief"} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 179033 [primary_image_old] => [slider_image_id] => 0 [banner_image] => 0 [title] => Mike on Medtech: Holiday Wish List, Part 1 [short_title] => [summary] => Sean Fenske and Mike Drues share their thoughts on what the industry might be looking for in the coming year. [slug] => mike-on-medtech-holiday-wish-list-part-1 [body] => In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss my lastest Editor’s Letter that appeared in the November/December issue of MPO, My Holiday Wish List (for Industry) (click here to read that Letter). In this Letter, I outlined a few things that I would like to see for the benefit of the medical device industry. The items included an improved image for the industry, pain management technologies market success, reform or improvment in reimbursement and CMS, and a couple other items. In part 1 of this two-part podcast series, we address the first item, an improved image, and discuss the recent "black eyes" suffered by the medtech industry, such as The Bleeding Edge documentary and an investative report that cited dangerous medical devices. We also discuss announced changes the FDA intends to introduce such as the 510k Modernization effort.

Listen to this episode and see what you think regarding the my holiday wish list. What did I leave off that should have been included? What's on your personal list? If you’d like to share thoughts and comments with us or have questions on the topic, please reach out to me with them at sfenske@rodmanmedia.com so I can perhaps discuss them with Mike in an upcoming episode.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.

You can check out the second part of this podcast series by clicking here.

Click here to review other podcasts.
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Olympus, which is located in Tokyo, Japan, and Hisao Yabe, 62, of Japan, both entered guilty pleas before U.S. District Court Judge Stanley R. Chesler in Newark Federal Court: Olympus to three counts, and Yabe to one count, of distributing misbranded medical devices in interstate commerce in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). 
 
Judge Chesler also imposed sentence on the company—fining Olympus $80,000,000 and ordering $5,000,000 in criminal forfeiture, consistent with a plea agreement between Olympus and the Justice Department. Olympus must also abide by an agreement with the Justice Department requiring Olympus to enact extensive compliance reforms.
 
Yabe is scheduled to be sentenced by Judge Chesler on March 27, 2019. Yabe faces a maximum potential penalty of a year in prison and a $100,000 fine, or twice the gain or loss from the offense.
 
Olympus admitted that it failed to file with the Food and Drug Administration (FDA) required adverse event reports in 2012 and 2013 relating to three separate events involving infections in Europe connected to Olympus’s TJF-Q180V duodenoscope (Q180V): the infection of approximately 22 patients with Pseudomonas aeruginosa at the Erasmus Medical Center in the Netherlands in early 2012; the infection of three patients with Escherichia coli at Clinique de Bercy in France in November 2012; and the infection of five patients with Pseudomonas aeruginosa at Kremlin Bicetre in France in July 2012.
 
Yabe admitted his own personal responsibility for the failure to file the necessary information with FDA relating to the Erasmus Medical Center infections. At the time, Yabe was Olympus’s Division Manager for the Quality and Environment Division—Olympus’s top regulatory official, whose responsibilities included adverse event reporting in the United States. 
 
“Medical devices, such as the Olympus duodenoscope that is used in 500,000 procedures per year in the United States, can extend and improve the quality of life for many people,” said Assistant Attorney General Jody Hunt for the Department of Justice’s Civil Division. “But when a device manufacturer becomes aware of risks that could lead to illness, injury, or death, there is a statutory obligation to report that information to the FDA in a timely manner. By failing to do so, Olympus and Mr. Yabe put patients’ health at risk.”
 
“Olympus and Yabe failed to file important FDA reports regarding adverse events,” Attorney for the United States Rachael Honig, District of New Jersey, said. “It is especially troubling that they remained quiet when they received additional information from an independent expert questioning the safety of Olympus’ device. Patient safety must always be a paramount concern for medical device companies, and these defendants simply failed to treat that concern with the gravity it deserves. The resolution is a reminder that this office will act whenever patient safety is put at risk by a quest for profits.”
 
“Medical device adverse event reporting requirements are designed to protect Americans by providing FDA with a tool to detect potential safety issues. When device manufacturers fail to report adverse events, unsuspecting patients are placed at risk,” said FDA Commissioner Scott Gottlieb, M.D. “We take our patient safety mission very seriously and we remain fully committed to aggressively pursuing those who jeopardize public health by subverting FDA’s regulatory requirements.”
 
Olympus’s and Yabe’s Failure to File Required Adverse Event Reports
To enable FDA and others to identify and monitor adverse events, the FDCA requires medical device manufacturers to file adverse event reports—known as Medical Device Reports (MDRs)—when the manufacturer becomes aware of information that reasonably suggests that the manufacturer’s device may have caused or contributed to a death or serious injury. The FDCA also requires manufacturers to file supplemental MDRs if they subsequently obtain information about the event that was not known or available when the initial MDR was filed.
 
Olympus admitted that it failed to make the required initial MDR filing regarding the Kremlin Bicetre infections, and failed to file required supplemental MDRs relating to the Erasmus Medical Center and Clinique de Bercy infections, for which Olympus had filed initial MDRs. Under the FDCA, devices for which required MDRs and supplemental MDRs have not been filed are deemed misbranded, and it is a crime to ship such devices in interstate commerce. Between August 2012 and October 2014, Olympus shipped hundreds of misbranded duodenoscopes in the United States, generating approximately $40 million in revenue and approximately $33 million in total gross profit. Olympus’s payment of $85 million is more than 2½ times Olympus’s total profit from sales of the misbranded duodenoscopes.
 
Yabe admitted that he was aware of Olympus’s obligation to file supplemental MDRs and was involved in Olympus’s failure to file a supplemental MDR regarding the Erasmus Medical Center infections and a report Olympus received prepared by an independent expert of Delft University of Technology in the Netherlands. That expert report—which Olympus obtained in the summer of 2012—noted numerous problems with the Q180V, including that the Q180V’s tip had various cracks, corners, and crevices that could harbor bacteria and could be cleaned only with great difficulty. The report recommended immediate further investigation of all such scopes, updating the cleaning instructions, and improving the quality of the seals.
 
Additional Compliance Measures
As part of its plea agreement with the Justice Department, Olympus has agreed to: retain an independent MDR expert to inspect and review Olympus’s policies and procedures to determine their compliance with the MDR requirements of the FDCA and its implementing regulations; periodic review by the MDR expert of Olympus’s continued compliance with the MDR requirements of the FDCA and its implementing regulations; and conduct a review and audit of the device classification and market pathway for all endoscope device types manufactured by Olympus that are intended for use in the sterile body cavity and that are currently sold in the United States. The MDR expert will report back to FDA and the Justice Department periodically for three years. In addition, the President of Olympus and Olympus’s Board of Directors will periodically conduct a review of Olympus’s MDR compliance measures and classification/marketing pathway review and provide certifications to FDA and the Justice Department relating to those reviews. Olympus also is obligated to inform health care providers in the United States who received Q180Vs between August 2012 and October 2014 of Olympus’s plea, and to provide information to those health care providers regarding Olympus’s failure to file the required MDRs.
 
In March 2016, Olympus Corp. of the Americas and Olympus Latin America, two separate subsidiaries of Olympus Corp., entered into deferred prosecution agreements (DPAs) and civil settlements with the U.S. Attorney’s Office for the District of New Jersey and the Justice Department’s Civil Division to resolve criminal and civil charges and civil claims relating to schemes between 2006-2011 to pay kickbacks to doctors and hospitals in the United States and violate the Foreign Corrupt Practices Act in Latin America. The DPAs are scheduled to expire in March 2019. While the unlawful conduct at issue in the resolution terminated in October 2014—a year and a half before the government entered into the DPAs—conduct relating to violations of the FDCA and failure to file MDRs was specifically not covered by the March 2016 resolution, as the investigation into the FDCA violations was ongoing at that time.
 
The guilty pleas are the culmination of an investigation conducted by special agents from FDA’s Office of Criminal Investigations, under the direction of Special Agent in Charge Jeffrey J. Ebersole of the New York Field Office, along with special agents from the U.S. Department of Health and Human Services, Office of Inspector General, under the direction of Special Agent in Charge Scott J. Lampert, and special agents of the FBI, under the direction of Special Agent in Charge Gregory W. Ehrie.
 
The government is represented in the criminal case by Assistant U.S. Attorneys Jacob T. Elberg and R. David Walk, Jr. of the U.S. Attorney’s Office’s Health Care and Government Fraud Unit, and Senior Litigation Counsel Patrick Jasperse of the Justice Department’s Consumer Protection Branch, with the assistance of Senior Counsel Shannon M. Singleton of the FDA’s Office of Chief Counsel. 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