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    [title] => FDA OKs Visura Technologies' TEE Camera Assist Device System
    [short_title] => 
    [summary] => Device uniquely addresses the challenge of blind TEE probe intubation.
    [slug] => fda-oks-visura-technologies-tee-camera-assist-device-system
    [body] => Visura Technologies, a start-up medical device company based in Evanston, Ill., has received 510(k) clearance from the US Food and Drug Administration (FDA) for its TEE Camera Assist Device (TEECAD) System. TEECAD’s single-use disposable camera easily attaches to a transesophageal echocardiogram (TEE) ultrasound probe allowing physicians to view the upper airway and esophagus during probe placement for safe intubation.
 
TEE is a common cardiovascular procedure, performed more than 500,000 times annually in the US, in which an ultrasound probe is placed in the patient’s esophagus to capture high-resolution ultrasound images of the heart valves and atria. Physicians currently place TEE probes blindly, guided by physician feel and patient cooperation, potentially resulting in failed intubations that can lead to cancelled therapeutic procedures and major complications such as esophageal or pharyngeal perforation.
 
Visura Founder Dr. David Marmor, a noninvasive cardiologist and experienced TEE operator, commented, “TEE related complications and failed intubations can be dangerous for patients and have costly ramifications for hospitals. The recent proliferation of catheter-based structural heart interventions reliant on TEE imaging has led to growth in procedural volume and an increase in the age and risk profile of patients, increasing the need for visual guidance for safe TEE probe intubation. We look forward to clinically introducing our device.”
 
The TEECAD System consists of a single-use disposable camera Carrier that removably attaches to the TEE probe, and a separate Viewing System display that allows the physician to view real-time images from the camera to visually assist with safe probe intubation. The clearance of Visura’s first TEECAD camera Carrier is for use with the Philips X7-2t probe. The company plans to develop additional Carrier models compatible with other TEE probes available in the market.
 
Established in 2015, Visura Technologies is a medical device company dedicated to improving the safety and success of transesophageal echocardiography procedures. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-07-10 11:09:00 [updated_at] => 2018-07-10 11:15:22 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["283840","282940","282929","272166","271971","270284","269237","279140","282676","279340","285570","284492","283698","283586","282849","282390","281299","280635","279504","279103"] [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] => 2487 [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] => breaking_news [short_tag] => breaking_news [class_name] => [display_view] => [list_view] => [slug] => breaking-news [box_view] => [ignore_flag] => 0 [image_id] => 0 [layout_id] => 0 [formattedTag] => Breaking News ) [viewURL] => /contents/view_breaking-news/2018-07-10/fda-oks-visura-technologies-tee-camera-assist-device-system/ [relatedArticles] => Array ( [0] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 269237 [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":"GlobeNewswire","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 161376 [primary_image_old] => [slider_image_id] => 161376 [banner_image] => 0 [title] => Medtronic and Philips Partner to Advance Lung Cancer Management [short_title] => [summary] => Healthcare leaders join to streamline and optimize the management of lung nodules with LungGPS Patient Management Platform. [slug] => medtronic-and-philips-partner-to-advance-lung-cancer-management [body] => In a collective effort to improve the management of patients with lung nodules, Medtronic plc and Royal Philips have entered into a business relationship to develop and commercialize the LungGPS Patient Management Platform. The comprehensive patient and data management platform is designed to streamline the management of lung nodule patients from identification through diagnosis, treatment, and long-term survivorship.
 
Lung cancer remains the number one cancer killer in the world, accounting for more cancer deaths than breast, colon and prostate cancer combined1. In its early stages, lung cancer presents few, if any, symptoms. Lung nodules, also referred to as "spots" or "shadows" on the lung, are usually benign. But when found early, nodules can be continuously monitored for growth, which is a sign that the nodule could become cancerous.
 
When lung nodules are found, the lack of infrastructure, coordination and capacity to manage identified patients in a timely manner can lead to delays in diagnosis and treatment. Studies demonstrate the majority of patients with incidental nodule identification don't receive appropriate follow up2.They often go home either unaware of the issue or the importance of action.
 
Together, the companies' early commercialization efforts will provide multiple solutions that focus on integrating hospital data, patient management, and clinical workflows. The LungGPS platform is designed to make it easier for clinicians to identify and manage patients with incidental pulmonary nodules within disparate hospital information systems.
 
The LungGPS platform3 uses:
   
Once a lung nodule patient is identified, the software helps guide those patients into an appropriate clinical workflow—allowing for quick evaluation of those who may be at risk of lung cancer and effective and efficient management of those that require long-term surveillance.
 
"Lung cancer rates haven't changed much over the past three decades. The current management of incidental lung nodule tracking is a very manual process, one that includes spreadsheets or post-it notes or no active management at all. It's time we think differently about how we're going to tackle this disease, and bring lung healthcare into the twenty-first century," said Matt Anderson, vice president and general manager of Lung Health, which is part of the Surgical Innovations division in the Minimally Invasive Therapies Group at Medtronic. "No one single company can tackle this alone and through our collaboration with Philips, we have the opportunity to help achieve better outcomes for these patients—using technology to promote integrated care."
 
"Early identification and prompt, appropriate management of pulmonary nodule patients has been proven to improve clinical outcomes. Developing technological solutions to enable our customers to do this quickly, efficiently and consistently continues to be our focus and we're excited about the expanded possibilities through our new collaboration with Medtronic," said Brent Berthy, head of Oncology Solutions at Philips. "The combination of our collective capabilities in imaging, informatics and image-guided intervention has the ability to make a meaningful, positive impact on patient care, clinical outcomes and survivorship."
 
References
1American Cancer Society: Cancer Facts & Figures 2013
2Blagev, et al, "Follow up of Incidental Pulmonary Nodules and Radiology Reports" J Am Coll Radiol 2014;11:378-383
3Data on file at Philips. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-01-30 11:11:00 [updated_at] => 2018-01-30 11:15:57 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["268098","265796","263655","261840","260492","260163","259792","259558","259242","257227","267466","259935","261842","264926","259123","258803","258326","264693"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [1] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 270284 [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] => 162086 [primary_image_old] => [slider_image_id] => 162086 [banner_image] => 0 [title] => Philips Recalls HeartStart MRx Defibrillator Due to Defects in Gas Discharge Tubes [short_title] => [summary] => Micro cracks in the tubes may cause device failure, including when delivering repeated shocks in AED mode. [slug] => philips-recalls-heartstart-mrx-defibrillator-due-to-defects-in-gas-discharge-tubes [body] => The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
 
Recalled Product(s):
   
The Philips HeartStart MRx Defibrillator is used to pace people with a slow heart beat or to deliver lifesaving electrical shocks to people with sudden cardiac arrest, a medical condition in which the heart suddenly and unexpectedly stops beating. Electrodes are attached to the patient and then connected to the device to help it analyze a patient's heart rhythm. The electrodes deliver an electrical shock to restore a normal heart rhythm during sudden cardiac arrest, or to pace the heart at a normal rate when it slows down.
 
The HeartStart MRx Monitor/Defibrillator is intended for use by or on the order of a physician, and should only be administered by medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation.
 
Philips is recalling the HeartStart MRx Defibrillator due to a defect in the device's Gas Discharge Tube (GDT). The GDT has micro cracks which allows internal gasses to escape and causes the tubes to not function as expected. This also permits an electrical current surge to cross the device's designated resistors, which will damage the resistors and prevent the device from working while in automated external defibrillator (AED) mode.
 
As a result of this GDT defect, the HeartStart MRx may fail at any time, including when delivering repeated shocks in AED mode, or during the periodic Operational Check outlined in the device's Instructions for Use. If the device is used in AED mode after failure, the device will not deliver patient therapy. Continued use of the device in AED mode after failure may lead to serious patient injury or death.
 
However, the HeartStart MRx will continue to work in "Manual" mode after AED mode failure, though the electrocardiogram (EKG) displayed on the device will be noisy, which may make provider interpretation difficult.
 
Who May Be Affected
 
What to Do
On June 13, 2017, Philips Electronics sent affected customers a "Medical Device Correction Notification" informing them of the device's risks. In the letter, Philips directed customers to:
   
If the device fails to function, users:
  [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-02-12 14:24:00 [updated_at] => 2018-02-12 14:28:47 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["269237","261840","260492","255515","254654","263828","267298","264335","255868","263868","262759","269320","269060","267660","266964","266470","264835","263664","263663","262258"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [2] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 271971 [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":"PR Newswire","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 162937 [primary_image_old] => [slider_image_id] => 162937 [banner_image] => 0 [title] => Philips Launches Digital Ingenia Elition 3.0T MRI [short_title] => [summary] => The new MRI delivers very high digital image quality up to 50 percent faster. [slug] => philips-launches-digital-ingenia-elition-30t-mri [body] => Royal Philips announced the newest addition to its digital Ingenia MR portfolio, the Ingenia Elition, a new 3.0T MRI solution. Integrating the latest innovations in systems, software and services, the Ingenia Elition MR solution offers extraordinary image quality and performs exams up to 50 percent faster1, with no compromise in image quality—empowering a faster, smarter and simpler path to confident diagnosis, elevating the patient experience and helping to improve patient care.
 
"As value-based care initiatives challenge healthcare organizations to drive better outcomes, radiology departments are specifically caught between ever-increasing imaging volume demands, while also facing pressure to engage more deeply with both referring physicians and patients," said Arjen Radder, Business Leader MR at Philips. "Philips is responding to these challenges through the development of solutions such as Ingenia Elition to improve image quality and the patient and staff experience, as well as operational efficiency."
 
Intelligent and Patient-Friendly MR Platform 
The Ingenia Elition MR solution delivers patient-centric imaging from patient set-up to the final image. By uniting Philips' unique dStream digital broadband technology with Compressed SENSE2, and 3D APT across its new digital MR portfolio, radiologists have the tools necessary to help solve challenging clinical situations, improve the patient experience and set new directions for clinical research.


Philips’ VitalEye patient sensing technology and algorithms process over two hundred body locations in parallel to intelligently extract signs of breathing.

 
Unique Patient Sensing Technology 
New patient sensing technology and AI-driven SmartExam analytics for automatic planning, scanning and processing of exams help improve the entire MR workflow, from image acquisition to reading preference. Ingenia Elition's VitalScreen offers operators fully guided patient setup with a newly designed user interface for workflow optimization and VitalEye brings a unique patient sensing approach, enabling respiratory signal without any interaction from the operator. VitalEye technology and algorithms process over two hundred body locations in parallel to intelligently extract signs of breathing—allowing routine exam set-up time to occur in less than a minute, even for less experienced operators.3
 
Philips Ambient Experience and in-bore Connect solution, offering an immersive audio-visual experience to calm patients and guide them through MR exams, further improves the patient experience. A study at Herlev Gentofte University Hospital in Denmark showed that the Ambient Experience in-bore Connect solution helped reduce the number of rescans by up to 70 percent4, allowing radiologists to handle more patients per day. The unique combination of innovations that the new Ingenia Elition offers is improving the entire workflow from image acquisition to reading preferences.
 
All-New Ingenia Digital MR Portfolio 
The Ingenia Elition 3.0T is part of the all-new Ingenia digital MR portfolio and complements the recently introduced Philips Ingenia Prodiva 1.5T MR solution. Philips' new MR portfolio supports radiology departments to enhance productivity, improving the patient and staff experience, while delivering better value-based care through improved patient outcomes at lower costs.


Philips’ Ambient Experience and in-bore Connect solution offers an immersive experience to calm patients and guide them through MR exams.

 
Philips will officially unveil Ingenia Elition and its newest MR innovations, alongside its full suite of solutions for diagnosis and treatment during the 2018 European Congress of Radiology at booth #402 in X4 at the Austria Center in Vienna.
 
References
1Using Compressed SENSE technology and compared to exams without Compressed SENSE
2510k pending. Not available for sale in the USA or Canada. Not yet CE marked. Not yet available for delivery.
3Based on in house testing.
4Results from case studies are not predictive of results in other cases. Results in other cases may vary.  [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-02-28 13:46:00 [updated_at] => 2018-02-28 13:56:45 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["270284","269237","261840","260492","263828","267298","264335","255868","263868","263041","263835","114790"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [3] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 272166 [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":"PR Newswire","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 163095 [primary_image_old] => [slider_image_id] => 163095 [banner_image] => 0 [title] => Philips and Hologic Partner to Provide Integrated Women's Health Imaging Solutions [short_title] => [summary] => Will allow integrated diagnostic imaging modalities, advanced informatics, and comprehensive breast screening and diagnosis. [slug] => philips-and-hologic-partner-to-provide-integrated-womens-health-imaging-solutions [body] => Royal Philips, a global developer of health technology, and Hologic Inc., a women's health company, announced a global partnership agreement to offer care professionals integrated solutions comprising diagnostic imaging modalities, advanced informatics and services for screening, diagnosis and treatment of women across the world. The collaboration combines Hologic's innovative mammography technologies and Philips' leading portfolio of ultrasound, MRI, CT, and X-ray systems, advanced informatics and broad range of services, including maintenance, upgrade, training and operational performance management services.
 
"No two women are alike, and we are teaming up with care providers and leading industry partners to support the delivery of a tailored, seamless breast care experience for women," said said Rob Cascella, CEO Diagnosis & Treatment businesses for Royal Philips. "That is why I am very pleased to announce our new partnership with Hologic for mammography. This partnership allows us to offer a complete set of innovative diagnostic imaging systems, software and services to our customers, including Hologic's market-leading mammography solutions for breast screening and diagnosis of women in need of care."
 
"Hologic believes in enabling doctors with superior technology that improves women's health through early detection and treatment," said Pete Valenti, Hologic's Division President, Breast and Skeletal Health Solutions. "Our market-leading mammography solutions perfectly complement Philips' portfolio, making Hologic the right industry partner for this first-of-its-kind collaboration. Now, through the partnership, Hologic can join Philips when engaging with customers on projects that were not previously possible for the two companies alone. It's a win for everyone involved, including the customers and patients we serve."
 
In breast care, Philips offers advanced imaging for ultrasound (e.g. Philips Affinity with Anatomical Intelligence for Breast), MRI (e.g. Philips Ingenia digital MRI with Compressed SENSE to speed up exam times), and PET/CT (e.g. Philips Vereos fully digital PET/CT), supported by intelligent image analysis, quantification, information management and workflow tools. Under the agreement, Philips will be able to offer select products from Hologic's breast health portfolio as part of multi-modality deals for hospitals and health systems. This will include Hologic's new 3Dimensions mammography system, the fastest, highest resolution breast tomosynthesis system in the industry, as well as other technologies for breast screening and interventional radiology1,2.
 
The multi-year, non-exclusive global partnership agreement allows for customized regional implementation to best meet the individual needs of each customer. The financial details of the agreement were not disclosed.
 
References
1Hologic Data on file
2Pending FDA approval and/or commercial availability [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-03-02 09:37:00 [updated_at] => 2018-03-02 09:47:18 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["271971","270284","269237","261840","260492","263828","267298","264335","263868","263041","264798","261284","262090","271192","272156","271932","271604","269320","269060","267660","266964","266470","264835","263664"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [4] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 279103 [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":"MasterControl","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 166492 [primary_image_old] => [slider_image_id] => 166493 [banner_image] => 0 [title] => Quality Nightmares #38: Audit Selection [short_title] => [summary] => Quality Nightmares offers a humorous look at the challenges faced by medtech professionals. [slug] => quality-nightmares-37-audit-selection [body] => An exclusive, rare inside look at a regulatory authority and its decision-making process.
 
Could you use some help with your audit preparation? Check out these solutions. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-04-27 07:45:00 [updated_at] => 2018-08-16 14:33:51 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["292170","291771","290458","289725","289377","287984","285570","284492","283698","283586","275121","271607","271604","276277","292606","292608","289767"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) ) [relatedContent] => Array ( [0] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 269237 [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":"GlobeNewswire","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 161376 [primary_image_old] => [slider_image_id] => 161376 [banner_image] => 0 [title] => Medtronic and Philips Partner to Advance Lung Cancer Management [short_title] => [summary] => Healthcare leaders join to streamline and optimize the management of lung nodules with LungGPS Patient Management Platform. [slug] => medtronic-and-philips-partner-to-advance-lung-cancer-management [body] => In a collective effort to improve the management of patients with lung nodules, Medtronic plc and Royal Philips have entered into a business relationship to develop and commercialize the LungGPS Patient Management Platform. The comprehensive patient and data management platform is designed to streamline the management of lung nodule patients from identification through diagnosis, treatment, and long-term survivorship.
 
Lung cancer remains the number one cancer killer in the world, accounting for more cancer deaths than breast, colon and prostate cancer combined1. In its early stages, lung cancer presents few, if any, symptoms. Lung nodules, also referred to as "spots" or "shadows" on the lung, are usually benign. But when found early, nodules can be continuously monitored for growth, which is a sign that the nodule could become cancerous.
 
When lung nodules are found, the lack of infrastructure, coordination and capacity to manage identified patients in a timely manner can lead to delays in diagnosis and treatment. Studies demonstrate the majority of patients with incidental nodule identification don't receive appropriate follow up2.They often go home either unaware of the issue or the importance of action.
 
Together, the companies' early commercialization efforts will provide multiple solutions that focus on integrating hospital data, patient management, and clinical workflows. The LungGPS platform is designed to make it easier for clinicians to identify and manage patients with incidental pulmonary nodules within disparate hospital information systems.
 
The LungGPS platform3 uses:
   
Once a lung nodule patient is identified, the software helps guide those patients into an appropriate clinical workflow—allowing for quick evaluation of those who may be at risk of lung cancer and effective and efficient management of those that require long-term surveillance.
 
"Lung cancer rates haven't changed much over the past three decades. The current management of incidental lung nodule tracking is a very manual process, one that includes spreadsheets or post-it notes or no active management at all. It's time we think differently about how we're going to tackle this disease, and bring lung healthcare into the twenty-first century," said Matt Anderson, vice president and general manager of Lung Health, which is part of the Surgical Innovations division in the Minimally Invasive Therapies Group at Medtronic. "No one single company can tackle this alone and through our collaboration with Philips, we have the opportunity to help achieve better outcomes for these patients—using technology to promote integrated care."
 
"Early identification and prompt, appropriate management of pulmonary nodule patients has been proven to improve clinical outcomes. Developing technological solutions to enable our customers to do this quickly, efficiently and consistently continues to be our focus and we're excited about the expanded possibilities through our new collaboration with Medtronic," said Brent Berthy, head of Oncology Solutions at Philips. "The combination of our collective capabilities in imaging, informatics and image-guided intervention has the ability to make a meaningful, positive impact on patient care, clinical outcomes and survivorship."
 
References
1American Cancer Society: Cancer Facts & Figures 2013
2Blagev, et al, "Follow up of Incidental Pulmonary Nodules and Radiology Reports" J Am Coll Radiol 2014;11:378-383
3Data on file at Philips. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-01-30 11:11:00 [updated_at] => 2018-01-30 11:15:57 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["268098","265796","263655","261840","260492","260163","259792","259558","259242","257227","267466","259935","261842","264926","259123","258803","258326","264693"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [1] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 270284 [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] => 162086 [primary_image_old] => [slider_image_id] => 162086 [banner_image] => 0 [title] => Philips Recalls HeartStart MRx Defibrillator Due to Defects in Gas Discharge Tubes [short_title] => [summary] => Micro cracks in the tubes may cause device failure, including when delivering repeated shocks in AED mode. [slug] => philips-recalls-heartstart-mrx-defibrillator-due-to-defects-in-gas-discharge-tubes [body] => The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
 
Recalled Product(s):
   
The Philips HeartStart MRx Defibrillator is used to pace people with a slow heart beat or to deliver lifesaving electrical shocks to people with sudden cardiac arrest, a medical condition in which the heart suddenly and unexpectedly stops beating. Electrodes are attached to the patient and then connected to the device to help it analyze a patient's heart rhythm. The electrodes deliver an electrical shock to restore a normal heart rhythm during sudden cardiac arrest, or to pace the heart at a normal rate when it slows down.
 
The HeartStart MRx Monitor/Defibrillator is intended for use by or on the order of a physician, and should only be administered by medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation.
 
Philips is recalling the HeartStart MRx Defibrillator due to a defect in the device's Gas Discharge Tube (GDT). The GDT has micro cracks which allows internal gasses to escape and causes the tubes to not function as expected. This also permits an electrical current surge to cross the device's designated resistors, which will damage the resistors and prevent the device from working while in automated external defibrillator (AED) mode.
 
As a result of this GDT defect, the HeartStart MRx may fail at any time, including when delivering repeated shocks in AED mode, or during the periodic Operational Check outlined in the device's Instructions for Use. If the device is used in AED mode after failure, the device will not deliver patient therapy. Continued use of the device in AED mode after failure may lead to serious patient injury or death.
 
However, the HeartStart MRx will continue to work in "Manual" mode after AED mode failure, though the electrocardiogram (EKG) displayed on the device will be noisy, which may make provider interpretation difficult.
 
Who May Be Affected
 
What to Do
On June 13, 2017, Philips Electronics sent affected customers a "Medical Device Correction Notification" informing them of the device's risks. In the letter, Philips directed customers to:
   
If the device fails to function, users:
  [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-02-12 14:24:00 [updated_at] => 2018-02-12 14:28:47 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["269237","261840","260492","255515","254654","263828","267298","264335","255868","263868","262759","269320","269060","267660","266964","266470","264835","263664","263663","262258"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [2] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 271971 [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":"PR Newswire","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 162937 [primary_image_old] => [slider_image_id] => 162937 [banner_image] => 0 [title] => Philips Launches Digital Ingenia Elition 3.0T MRI [short_title] => [summary] => The new MRI delivers very high digital image quality up to 50 percent faster. [slug] => philips-launches-digital-ingenia-elition-30t-mri [body] => Royal Philips announced the newest addition to its digital Ingenia MR portfolio, the Ingenia Elition, a new 3.0T MRI solution. Integrating the latest innovations in systems, software and services, the Ingenia Elition MR solution offers extraordinary image quality and performs exams up to 50 percent faster1, with no compromise in image quality—empowering a faster, smarter and simpler path to confident diagnosis, elevating the patient experience and helping to improve patient care.
 
"As value-based care initiatives challenge healthcare organizations to drive better outcomes, radiology departments are specifically caught between ever-increasing imaging volume demands, while also facing pressure to engage more deeply with both referring physicians and patients," said Arjen Radder, Business Leader MR at Philips. "Philips is responding to these challenges through the development of solutions such as Ingenia Elition to improve image quality and the patient and staff experience, as well as operational efficiency."
 
Intelligent and Patient-Friendly MR Platform 
The Ingenia Elition MR solution delivers patient-centric imaging from patient set-up to the final image. By uniting Philips' unique dStream digital broadband technology with Compressed SENSE2, and 3D APT across its new digital MR portfolio, radiologists have the tools necessary to help solve challenging clinical situations, improve the patient experience and set new directions for clinical research.


Philips’ VitalEye patient sensing technology and algorithms process over two hundred body locations in parallel to intelligently extract signs of breathing.

 
Unique Patient Sensing Technology 
New patient sensing technology and AI-driven SmartExam analytics for automatic planning, scanning and processing of exams help improve the entire MR workflow, from image acquisition to reading preference. Ingenia Elition's VitalScreen offers operators fully guided patient setup with a newly designed user interface for workflow optimization and VitalEye brings a unique patient sensing approach, enabling respiratory signal without any interaction from the operator. VitalEye technology and algorithms process over two hundred body locations in parallel to intelligently extract signs of breathing—allowing routine exam set-up time to occur in less than a minute, even for less experienced operators.3
 
Philips Ambient Experience and in-bore Connect solution, offering an immersive audio-visual experience to calm patients and guide them through MR exams, further improves the patient experience. A study at Herlev Gentofte University Hospital in Denmark showed that the Ambient Experience in-bore Connect solution helped reduce the number of rescans by up to 70 percent4, allowing radiologists to handle more patients per day. The unique combination of innovations that the new Ingenia Elition offers is improving the entire workflow from image acquisition to reading preferences.
 
All-New Ingenia Digital MR Portfolio 
The Ingenia Elition 3.0T is part of the all-new Ingenia digital MR portfolio and complements the recently introduced Philips Ingenia Prodiva 1.5T MR solution. Philips' new MR portfolio supports radiology departments to enhance productivity, improving the patient and staff experience, while delivering better value-based care through improved patient outcomes at lower costs.


Philips’ Ambient Experience and in-bore Connect solution offers an immersive experience to calm patients and guide them through MR exams.

 
Philips will officially unveil Ingenia Elition and its newest MR innovations, alongside its full suite of solutions for diagnosis and treatment during the 2018 European Congress of Radiology at booth #402 in X4 at the Austria Center in Vienna.
 
References
1Using Compressed SENSE technology and compared to exams without Compressed SENSE
2510k pending. Not available for sale in the USA or Canada. Not yet CE marked. Not yet available for delivery.
3Based on in house testing.
4Results from case studies are not predictive of results in other cases. Results in other cases may vary.  [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-02-28 13:46:00 [updated_at] => 2018-02-28 13:56:45 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["270284","269237","261840","260492","263828","267298","264335","255868","263868","263041","263835","114790"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [3] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 272166 [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":"PR Newswire","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 163095 [primary_image_old] => [slider_image_id] => 163095 [banner_image] => 0 [title] => Philips and Hologic Partner to Provide Integrated Women's Health Imaging Solutions [short_title] => [summary] => Will allow integrated diagnostic imaging modalities, advanced informatics, and comprehensive breast screening and diagnosis. [slug] => philips-and-hologic-partner-to-provide-integrated-womens-health-imaging-solutions [body] => Royal Philips, a global developer of health technology, and Hologic Inc., a women's health company, announced a global partnership agreement to offer care professionals integrated solutions comprising diagnostic imaging modalities, advanced informatics and services for screening, diagnosis and treatment of women across the world. The collaboration combines Hologic's innovative mammography technologies and Philips' leading portfolio of ultrasound, MRI, CT, and X-ray systems, advanced informatics and broad range of services, including maintenance, upgrade, training and operational performance management services.
 
"No two women are alike, and we are teaming up with care providers and leading industry partners to support the delivery of a tailored, seamless breast care experience for women," said said Rob Cascella, CEO Diagnosis & Treatment businesses for Royal Philips. "That is why I am very pleased to announce our new partnership with Hologic for mammography. This partnership allows us to offer a complete set of innovative diagnostic imaging systems, software and services to our customers, including Hologic's market-leading mammography solutions for breast screening and diagnosis of women in need of care."
 
"Hologic believes in enabling doctors with superior technology that improves women's health through early detection and treatment," said Pete Valenti, Hologic's Division President, Breast and Skeletal Health Solutions. "Our market-leading mammography solutions perfectly complement Philips' portfolio, making Hologic the right industry partner for this first-of-its-kind collaboration. Now, through the partnership, Hologic can join Philips when engaging with customers on projects that were not previously possible for the two companies alone. It's a win for everyone involved, including the customers and patients we serve."
 
In breast care, Philips offers advanced imaging for ultrasound (e.g. Philips Affinity with Anatomical Intelligence for Breast), MRI (e.g. Philips Ingenia digital MRI with Compressed SENSE to speed up exam times), and PET/CT (e.g. Philips Vereos fully digital PET/CT), supported by intelligent image analysis, quantification, information management and workflow tools. Under the agreement, Philips will be able to offer select products from Hologic's breast health portfolio as part of multi-modality deals for hospitals and health systems. This will include Hologic's new 3Dimensions mammography system, the fastest, highest resolution breast tomosynthesis system in the industry, as well as other technologies for breast screening and interventional radiology1,2.
 
The multi-year, non-exclusive global partnership agreement allows for customized regional implementation to best meet the individual needs of each customer. The financial details of the agreement were not disclosed.
 
References
1Hologic Data on file
2Pending FDA approval and/or commercial availability [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-03-02 09:37:00 [updated_at] => 2018-03-02 09:47:18 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["271971","270284","269237","261840","260492","263828","267298","264335","263868","263041","264798","261284","262090","271192","272156","271932","271604","269320","269060","267660","266964","266470","264835","263664"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [4] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 279103 [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":"MasterControl","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 166492 [primary_image_old] => [slider_image_id] => 166493 [banner_image] => 0 [title] => Quality Nightmares #38: Audit Selection [short_title] => [summary] => Quality Nightmares offers a humorous look at the challenges faced by medtech professionals. [slug] => quality-nightmares-37-audit-selection [body] => An exclusive, rare inside look at a regulatory authority and its decision-making process.
 
Could you use some help with your audit preparation? Check out these solutions. 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