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    [title] => FDA Grants First-Ever Clearances to Detect Bradycardia and Tachycardia on a Personal ECG Device
    [short_title] => 
    [summary] => AliveCor's KardiaMobile is now the only personal ECG to detect the three most common heart arrhythmias.
    [slug] => fda-grants-first-ever-clearances-to-detect-bradycardia-and-tachycardia-on-a-personal-ecg-device
    [body] => AliveCor, the developer of FDA-cleared consumer electrocardiogram technology (ECG), announced two additional FDA 510(k)-cleared indications, making KardiaMobile the only consumer ECG device in the world with FDA-clearance to detect the three most common heart arrhythmias.
 
In addition to detecting Atrial Fibrillation (AFib) and Normal Sinus Rhythm, AliveCor is able to detect and show ECG results for Bradycardia and Tachycardia. These instant analyses indicate arrhythmias that are not AFib and that are between 40-50 beats per minute (Bradycardia), or between 100-140 beats per minute (Tachycardia).
 
"No other consumer ECG device in the world, can tell you more about your heart than KardiaMobile," said AliveCor CEO, Ira Bahr. "Until today, patients have been frustrated when devices label their ECG reading as 'unclassified' or 'inconclusive.' Starting today, KardiaMobile is the first personal ECG device that can begin to materially reduce the number of those determinations. Critically, KardiaMobile is also the only personal ECG that can detect Atrial Fibrillation at heart rates above 120, and heart rates below 40."
 
Bradycardia and tachycardia, which literally mean "slow heart" and "fast heart", respectively, occur in nearly all adults. While the normal range of heart rate is between 50 and 100 beats per minute, there are many scenarios where the rate can be slightly out of this range. For example, the heart may slow below 50 beats per minute during sleep, and naturally, in many healthy adults and athletes. A fast heart rate may naturally occur in response to exercise, anxiety, or pain.
 
While Bradycardia and Tachycardia are often benign, these arrhythmias can be indicative of heart disease or other health conditions, such as thyroid disease. A slow or fast heart rate may be asymptomatic, or cause symptoms such as dizziness or shortness of breath. KardiaMobile users will now be able to detect these arrhythmias and use the insight to inform conversations with their doctor. Beyond the patient-doctor relationship, KardiaMobile also provides peace of mind by diminishing the number of unclassified readings that users may receive.
 
"Tachycardia and bradycardia are common because they are often the body's natural response to everyday life, from physical activity and sleep to emotions and overall health," said Dr. Jacqueline Shreibati, CMO of AliveCor. "While we have traditionally focused on the patient empowerment that comes from increased awareness of atrial fibrillation, we are excited to give all of our users more actionable insights into their heart health." [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2019-04-24 09:31:00 [updated_at] => 2019-04-24 09:35:53 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["310103","310323","307704","309362","303313","304315","306112","308828","306548","305978","312688","312599","312494","312310","311551"] [is_show_company_name] => [created_at] => 2019-04-24 09:25:41 [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/2019-04-24/fda-grants-first-ever-clearances-to-detect-bradycardia-and-tachycardia-on-a-personal-ecg-device/ [relatedArticles] => Array ( [0] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 303313 [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] => 178864 [primary_image_old] => [slider_image_id] => [banner_image] => 0 [title] => First Patient Treated in Medtronic's TERMINATE AF Clinical Trial [short_title] => [summary] => Study to evaluate use of radiofrequency & cryosurgical ablation devices in cardiac surgery patients with atrial fibrillation. [slug] => first-patient-treated-in-medtronics-terminate-af-clinical-trial [body] => Medtronic plc announced the first patient treated in the TERMINATE AF trial, a multi-center study evaluating two surgical ablation devices—the Cardioblate Irrigated RF (IRF) System and the CryoFlex Surgical Ablation System—for the treatment of non-paroxysmal (persistent or longstanding persistent) atrial fibrillation (AF) in patients undergoing open-heart surgical procedures. Following investigational device exemption (IDE) approval by the U.S. Food and Drug Administration (FDA), the first patient was treated in the study by the heart team led by Ralph Damiano, M.D., at Washington University School of Medicine in St. Louis. In the U.S., use for treatment of AF is investigational use only.
 
During the surgical ablation procedure, surgeons will use the two ablation devices—deploying both "heat" (Cardioblate Irrigated Radio Frequency ablation) and "cold" (CryoFlex cryoablation) as needed—to make a pattern of lesions in the heart muscle, which are intended to help the heart to return to its normal rhythm. The investigational procedure will be conducted to evaluate the treatment of atrial fibrillation in patients during other surgical heart procedures, such as bypass surgery, heart valve repair or replacement.
 
"The Terminate AF trial provides a unique opportunity to study the combined use of two surgical ablation technologies to treat surgical patients who suffer from AF," said Ralph J. Damiano, M.D., chief of the Division of Cardiothoracic Surgery at Washington University School of Medicine and Barnes Jewish Hospital, and national principal investigator of the Terminate AF trial. "We anticipate the trial will help us uncover important procedural insights and potentially help surgeons and heart teams treat more patients with this widespread disease."
An estimated 2.7—6.1 million people in the U.S. have AF, which contributes to an increased risk of stroke and an annual healthcare cost of $6 billion.1
 
The study, which will be conducted at up to 15 centers in the U.S., will evaluate the safety and efficacy of the Cardioblate iRF and CryoFlex devices in up to 160 patients with a history of non-paroxysmal AF who are undergoing concomitant cardiac surgery. The primary efficacy endpoint is the absence of AF after the removal of antiarrhythmic drug therapy (three months post-procedure). Patients will be assessed at one, three, six and 12 months.
 
"The commencement of the TERMINATE AF trial furthers our continued commitment to cardiac surgery," said John Mack, vice president and general manager of the Cardiac Surgery business, which is part of the Cardiac and Vascular Group at Medtronic. "An indication for the surgical treatment of AF would enable physician training and education and would serve as the basis for ongoing clinical evidence generation."
 
The Cardioblate Irrigated RF (IRF) and CryoFlex Surgical Ablation Systems received 510(k) clearance from FDA in 2000 and 2004, respectively, with a general indication to ablate cardiac tissue during cardiac surgery. Neither device is FDA cleared or approved for the treatment of AF.

References
1 https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_atrial_fibrillation.htm [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-12-03 09:21:00 [updated_at] => 2018-12-03 09:26:24 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["294748","283697","284246","287984","284487","300284","282656","282845","287964","300778","302016","282688","300250","302305","302922","296562","282670","299802"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [1] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 304315 [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] => 179620 [primary_image_old] => [slider_image_id] => 179620 [banner_image] => 0 [title] => The First AI-Driven Wearable Heart Monitor to Prevent Heart Disease and Stroke [short_title] => [summary] => Cambridge Cardiologist and Cardiology MIT fellow to release the "Heartsense monitor." [slug] => the-first-ai-driven-wearable-heart-monitor-to-prevent-heart-disease-and-stroke [body] => Cambridge Heartwear, a medical provider of low-cost, next-generation wearable heart monitors that uses artificial intelligence (AI) to diagnose heart rhythm and respiratory problems in real time is announcing the launch of their company and release of their Heartsense monitor in 2019. In the U.S., strokes are among the leading causes of death and heart disease is the leading killer. National and international data suggests that more than 80 percent of those who die or who are left with severe neurological deficits following a stroke had an irregular heartbeat as the underlying cause.
 
Atrial fibrillation (AF) or AFib is an irregular heart rhythm that can lead to heart conditions such as blood clots, stroke, and heart failure. Cambridge Heartwear's solution to detecting AF and heart disease is an ergonomically designed and easy to wear a heart monitor that provides continuous monitoring of heart rhythms via electrocardiograms (ECGs) and the automatic interpretation and detection of irregularities using artificial intelligence.
 
Unlike other wearable healthcare devices that originated from a "product first, healthcare second' approach, the Heartsense monitor was born out of the real-life clinical practice of Cambridgecardiologist and cardiology MIT fellow Dr. Rameen Shakur.
 
"Our vision behind forming Cambridge Heartwear was to create a bespoke and patient-driven solution to the problem of preventing stroke and heart disease," said Dr. Shakur, founder and CEO of Cambridge Heartwear. "The technology and clinical care systems we currently have in place are not picking up atrial fibrillation before someone has a stroke and do not enable us to put preventative treatment in place. While there are wearable devices that do general health detection, there is currently no medically-driven device on the market coming out of a clinical practice. There is a critical need for a holistic, multi-input and patient-driven device that takes into account the complex physiology of a patient. We are the first patient-driven AI wearable device born out of real-life clinical practice, not an engineering lab."
 
Cambridge Heartwear's Heartsense monitor is the only wirelessly chargeable heart health device on the market that uses real-time, pulse oximetry and multiple ECG inputs. When using the device, patients control and own their own heart data. Should they choose to, patients can also allow the device to securely acquire and transmit their real-time data to their physician. The platform allows patient's data to be shared with physicians the moment activity is started.
 
The AI healthcare sector is one of the fastest growing markets that virtually pays for itself. Unlike other healthcare verticals that require investments, AI is autonomous in generating revenue and year over year growth. In 2014, AI healthcare was valued at $600 million; by 2021, the AI health market is expected to reach $6.6 billion, which is a compound annual growth rate of 40 percent.
 
The Cambridge Heartsense monitor is already undergoing clinical trials among top-tier athletic organizations in the UK and the U.S. It was recently awarded on PwC's List of Most Innovative and Disruptive New Companies in the U.K. The company is also providing Heartsense monitors to communities in India and Africa to help prevent heart disease and stroke amongst patients. The device will be available on the market in early 2019. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-12-14 09:46:00 [updated_at] => 2018-12-14 09:50:03 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["301046","304193","299739","285594","300075","284024","303655","284243","283959","303607","304247","303994","300325","299507","293406","283958","289755","303895"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [2] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 305978 [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":"Johnson & Johnson","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 180989 [primary_image_old] => [slider_image_id] => 180989 [banner_image] => 0 [title] => J&J, Apple Seek to Improve AFib Outcomes [short_title] => [summary] => Companies to collaborate to assess impact of wearable technology on earlier detection of AFib, improved diagnosis, and patient outcomes. [slug] => jj-apple-seek-to-improve-afib-outcomes [body] => Johnson & Johnson has announced that Janssen Pharmaceuticals Inc., member of the Johnson & Johnson Family of Companies, entered into a research study in collaboration with Apple Inc. to investigate whether a new heart health program using an app from Johnson & Johnson in combination with Apple Watch’s irregular rhythm notifications and ECG app can accelerate the diagnosis and improve health outcomes of the 33 million people worldwide living with atrial fibrillation (AFib), a condition that can lead to stroke and other potentially devastating complications. In the U.S. alone, AFib is responsible for approximately 130,000 deaths and 750,000 hospitalizations every year.
 
The study aims to analyze the impact of Apple Watch on the early detection and diagnosis of AFib, and the potential to improve outcomes including the prevention of stroke. A multi-year research program will be launched later in 2019. This large-scale program will occur in the U.S. only, and will be designed as a pragmatic randomized controlled research study for individuals age 65 years or older.
 
The study’s goals include:  
“We’re excited about the potential of common, wearable technology to aid in the earlier detection and prevention of a frequent cause of stroke,” said Paul Stoffels, M.D., vice chair of the executive committee and chief scientific officer, Johnson & Johnson. “Too many people living with AFib are unaware of their risk, and earlier detection, diagnosis and treatment of AFib could significantly improve outcomes. Based on the insights generated through this research program, we may be able to develop new ways to detect other health conditions earlier in the future that also exhibit measurable physiological symptoms.”
 
“Through Apple Watch people have been able to learn more about their heart health, including discovering they have AFib. This kind of information empowers customers to follow up with the right treatment or even better, implement healthy habits aimed at prevention,” said Jeff Williams, chief operating officer, Apple Inc. “We’re excited to work with Johnson & Johnson, a leader in the medical community, as we learn about the impact Apple Watch can have in delivering better health outcomes.”
 
Johnson & Johnson’s recent mSTOPs (mHealth Screening to Prevent Strokes) study demonstrated that earlier screening leads to increased AFib detection. “Utilizing wristwatch-based optical heart sensor and ECG monitoring is a logical evolution of this research and may also lead to increased AFib diagnosis and improved clinical outcomes for patients,” said Paul Burton, M.D., Ph.D., FACC, vice president, medical affairs, internal medicine, Janssen Scientific Affairs, LLC.
 
“This collaboration brings together Johnson & Johnson’s depth of expertise and long heritage in treating cardiovascular disease with Apple’s experience in utilizing cutting-edge technologies to improve the lives of consumers. Ultimately, we hope to improve the treatment of cardiovascular disease, and identify ways to prevent it.” [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2019-01-17 09:42:00 [updated_at] => 2019-01-17 09:43:50 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["300443","289758","299472","302033","305381","301830","299952","289745","302205","304505","300397","302922","296472","299802","289752","289718","303896"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [3] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 306112 [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":"Abbott Laboratories","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 181117 [primary_image_old] => [slider_image_id] => 181117 [banner_image] => 0 [title] => FDA Approves Abbott's New TactiCath Contact Force Ablation Catheter [short_title] => [summary] => Abbott is helping more physicians integrate ablation with 3D mapping to advance the treatment of people with atrial fibrillation. [slug] => fda-approves-abbotts-new-tacticath-contact-force-ablation-catheter [body] => Abbott today announced U.S. Food and Drug Administration (FDA) approval of the TactiCath Contact Force Ablation Catheter, Sensor Enabled, a new ablation catheter designed to help physicians accurately and effectively treat atrial fibrillation (AFib). The approval further expands Abbott's portfolio of cardiac ablation tools that integrate with the company's EnSite Precision cardiac mapping system to help physicians develop more precise images of the heart during cardiac ablation procedures.
 
Similar to Abbott's other sensor-enabled mapping and ablation treatment catheters, TactiCath (Sensor Enabled) SE delivers more precise images of the heart overlaid with real-time electrical activity information. The catheter also utilizes the advanced ergonomic design found in the company's FlexAbility ablation catheter for superior reach and maneuverability during cardiac ablation procedures.
 
"Cardiac ablation has become a front-line therapy in the fight against conditions like atrial fibrillation in part because of improvements to the technology available today," said Roger Winkle, M.D., an electrophysiologist at Sequoia Hospital in Redwood City, Calif., and one of the first physicians to treat patients with the newly FDA-approved catheter. "The Abbott TactiCath SE ablation catheter represents one of those major improvements, and offers an incredibly powerful, yet easy to use, combination of advanced technologies to improve ablation procedures."
 
Technological Advancements in Cardiac Ablation 
One of the most common cardiac arrhythmias in the world, AFib can affect how efficiently the heart pumps blood through the body, causing symptoms such as dizziness, shortness of breath or lightheadedness. The condition can also increase a person's risk of stroke. To treat conditions like AFib, physicians can use ablation catheters to scar tissue in the heart that is generating abnormal electrical signals and disrupting a patient's natural heartbeat. As the number of patients receiving cardiac ablation therapy worldwide has grown, Abbott has prioritized ablation technology that adds efficiency and accuracy to ablation procedures. Abbott cardiac ablation technology is currently used to treat patients in more than 84 countries worldwide.
 
Not all ablation technology is the same, however. Physicians have begun exploring the use of new tools such as "contact force" technology during ablation procedures to help them avoid applying too much pressure to heart tissue (resulting in complications) or insufficient pressure (which may reduce the effectiveness of the procedure). In addition, Abbott has also invested in technology to improve the accuracy of cardiac mapping to support cardiac ablation procedures.
 
Over the last two years, Abbott has expanded offerings within its electrophysiology portfolio to drive new growth and build on the company's leadership. In addition to new clinical trials to further build clinical evidence surrounding cardiac ablation, the company has also launched the Advisor HD Grid Mapping Catheter, Sensor Enabled, and the FlexAbility Ablation Catheter, Sensor Enabled.
 
"TactiCath SE directly supports our goal of supporting fast, effective and safe cardiac ablation procedures," said Srijoy Mahapatra, M.D., FHRS, medical director of Abbott's Electrophysiology business. "As more physicians turn to cardiac ablation to treat AFib, Abbott's goal is to equip them with the most advanced ablation catheters combined with the most advanced cardiac mapping on the market." [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2019-01-21 09:18:00 [updated_at] => 2019-01-21 09:25:04 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["305910","305696","300780","300499","300283","299288","290449","290175","289559","296226","305313","302016","300250","302305","302922","296562","304399","303313","299802","304100"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [4] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 306548 [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":"Globe Newswire ","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 181624 [primary_image_old] => [slider_image_id] => 181624 [banner_image] => 0 [title] => Medtronic to Acquire EPIX Therapeutics, Expanding Its Cardiac Ablation Portfolio [short_title] => [summary] => The DiamondTemp ablation system represents a disruptive RF innovation. [slug] => medtronic-to-acquire-epix-therapeutics-expanding-its-cardiac-ablation-portfolio [body] => Medtronic plc has entered into a definitive agreement to acquire EPIX Therapeutics Inc., a privately-held medical device company that designs and manufactures a novel, catheter-based, temperature-controlled cardiac ablation system for the treatment of patients with cardiac arrhythmias (irregular heartbeats), including atrial fibrillation (AF). When completed, the EPIX acquisition will expand the Medtronic cardiac ablation portfolio to offer physicians a comprehensive suite of tools to treat patients with cardiac arrhythmias.
 
EPIX's flagship technology, the DiamondTemp ablation system, is a unique closed-loop, temperature-controlled system that provides physicians with improved feedback and control during an ablation procedure. The DiamondTemp system uses radiofrequency (RF) energy (heat) to create scar tissue in the heart and complements the Medtronic cryoballoon technology that uses cryo energy (cold) to isolate the pulmonary veins (PVI).
 
The DiamondTemp system received CE Mark in Europe in 2017 and is limited to investigational use in the U.S. The DIAMOND-AF trial, which completed enrollment in Oct. 2018, will support approval of the DiamondTemp system in the U.S. for patients with symptomatic paroxysmal AF (AF that starts and stops intermittently). Additionally, the DIAMOND-AF II trial, which is currently enrolling patients, is evaluating the DiamondTemp system in patients with persistent AF (AF that continues for long periods of time).
 
"The DiamondTemp ablation system stands out from other RF ablation technologies because of the real-time temperature control via rapid power modulation. This results in shorter procedure times and higher confidence in lesion quality," said Atul Verma, M.D., Southlake Regional Health Center in Newmarket, Canada, and global principal investigator for the DIAMOND-AF II study. "I've had the pleasure of working with EPIX to design the DIAMOND-AF II trial and I look forward to continuing that work with Medtronic."
 
"The DiamondTemp cardiac ablation system represents leapfrog technology in the RF cardiac ablation space, a segment of the market where we haven't previously participated," said Rebecca Seidel, vice president and general manager of the Atrial Fibrillation Solutions division, which is part of the Cardiac and Vascular Group at Medtronic. "When combined with our existing leading cryoballoon technology, we expect to provide physicians with a complete portfolio of best-in-class cryo and RF systems."
 
The EPIX acquisition is expected to close in Medtronic's fourth fiscal quarter, which runs January 26 to April 26, 2019, subject to the satisfaction of certain customary closing conditions. EPIX is currently pre-revenue, and although the acquisition is expected to be dilutive to Medtronic's near-term adjusted earnings per share, Medtronic intends to offset the dilution. The transaction is expected to meet Medtronic's long-term financial metrics for acquisitions. Additional terms of the transaction were not disclosed.
 
The DiamondTemp ablation system is a temperature-controlled, irrigated RF ablation system for treating patients with AF. The DiamondTemp system is a closed-loop system with open irrigation and high-resolution electrograms, providing physicians with improved feedback and control during the ablation procedure which may improve AF treatment success. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2019-01-25 08:53:00 [updated_at] => 2019-01-25 10:13:42 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["305855","305410","305051","303783","303649","300633","300284","290459","302863","298715","294748","304069","299944","299472","300545","299797","289909","302205","304148"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) ) [relatedContent] => Array ( [0] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 303313 [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] => 178864 [primary_image_old] => [slider_image_id] => [banner_image] => 0 [title] => First Patient Treated in Medtronic's TERMINATE AF Clinical Trial [short_title] => [summary] => Study to evaluate use of radiofrequency & cryosurgical ablation devices in cardiac surgery patients with atrial fibrillation. [slug] => first-patient-treated-in-medtronics-terminate-af-clinical-trial [body] => Medtronic plc announced the first patient treated in the TERMINATE AF trial, a multi-center study evaluating two surgical ablation devices—the Cardioblate Irrigated RF (IRF) System and the CryoFlex Surgical Ablation System—for the treatment of non-paroxysmal (persistent or longstanding persistent) atrial fibrillation (AF) in patients undergoing open-heart surgical procedures. Following investigational device exemption (IDE) approval by the U.S. Food and Drug Administration (FDA), the first patient was treated in the study by the heart team led by Ralph Damiano, M.D., at Washington University School of Medicine in St. Louis. In the U.S., use for treatment of AF is investigational use only.
 
During the surgical ablation procedure, surgeons will use the two ablation devices—deploying both "heat" (Cardioblate Irrigated Radio Frequency ablation) and "cold" (CryoFlex cryoablation) as needed—to make a pattern of lesions in the heart muscle, which are intended to help the heart to return to its normal rhythm. The investigational procedure will be conducted to evaluate the treatment of atrial fibrillation in patients during other surgical heart procedures, such as bypass surgery, heart valve repair or replacement.
 
"The Terminate AF trial provides a unique opportunity to study the combined use of two surgical ablation technologies to treat surgical patients who suffer from AF," said Ralph J. Damiano, M.D., chief of the Division of Cardiothoracic Surgery at Washington University School of Medicine and Barnes Jewish Hospital, and national principal investigator of the Terminate AF trial. "We anticipate the trial will help us uncover important procedural insights and potentially help surgeons and heart teams treat more patients with this widespread disease."
An estimated 2.7—6.1 million people in the U.S. have AF, which contributes to an increased risk of stroke and an annual healthcare cost of $6 billion.1
 
The study, which will be conducted at up to 15 centers in the U.S., will evaluate the safety and efficacy of the Cardioblate iRF and CryoFlex devices in up to 160 patients with a history of non-paroxysmal AF who are undergoing concomitant cardiac surgery. The primary efficacy endpoint is the absence of AF after the removal of antiarrhythmic drug therapy (three months post-procedure). Patients will be assessed at one, three, six and 12 months.
 
"The commencement of the TERMINATE AF trial furthers our continued commitment to cardiac surgery," said John Mack, vice president and general manager of the Cardiac Surgery business, which is part of the Cardiac and Vascular Group at Medtronic. "An indication for the surgical treatment of AF would enable physician training and education and would serve as the basis for ongoing clinical evidence generation."
 
The Cardioblate Irrigated RF (IRF) and CryoFlex Surgical Ablation Systems received 510(k) clearance from FDA in 2000 and 2004, respectively, with a general indication to ablate cardiac tissue during cardiac surgery. Neither device is FDA cleared or approved for the treatment of AF.

References
1 https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_atrial_fibrillation.htm [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-12-03 09:21:00 [updated_at] => 2018-12-03 09:26:24 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["294748","283697","284246","287984","284487","300284","282656","282845","287964","300778","302016","282688","300250","302305","302922","296562","282670","299802"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [1] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 304315 [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] => 179620 [primary_image_old] => [slider_image_id] => 179620 [banner_image] => 0 [title] => The First AI-Driven Wearable Heart Monitor to Prevent Heart Disease and Stroke [short_title] => [summary] => Cambridge Cardiologist and Cardiology MIT fellow to release the "Heartsense monitor." [slug] => the-first-ai-driven-wearable-heart-monitor-to-prevent-heart-disease-and-stroke [body] => Cambridge Heartwear, a medical provider of low-cost, next-generation wearable heart monitors that uses artificial intelligence (AI) to diagnose heart rhythm and respiratory problems in real time is announcing the launch of their company and release of their Heartsense monitor in 2019. In the U.S., strokes are among the leading causes of death and heart disease is the leading killer. National and international data suggests that more than 80 percent of those who die or who are left with severe neurological deficits following a stroke had an irregular heartbeat as the underlying cause.
 
Atrial fibrillation (AF) or AFib is an irregular heart rhythm that can lead to heart conditions such as blood clots, stroke, and heart failure. Cambridge Heartwear's solution to detecting AF and heart disease is an ergonomically designed and easy to wear a heart monitor that provides continuous monitoring of heart rhythms via electrocardiograms (ECGs) and the automatic interpretation and detection of irregularities using artificial intelligence.
 
Unlike other wearable healthcare devices that originated from a "product first, healthcare second' approach, the Heartsense monitor was born out of the real-life clinical practice of Cambridgecardiologist and cardiology MIT fellow Dr. Rameen Shakur.
 
"Our vision behind forming Cambridge Heartwear was to create a bespoke and patient-driven solution to the problem of preventing stroke and heart disease," said Dr. Shakur, founder and CEO of Cambridge Heartwear. "The technology and clinical care systems we currently have in place are not picking up atrial fibrillation before someone has a stroke and do not enable us to put preventative treatment in place. While there are wearable devices that do general health detection, there is currently no medically-driven device on the market coming out of a clinical practice. There is a critical need for a holistic, multi-input and patient-driven device that takes into account the complex physiology of a patient. We are the first patient-driven AI wearable device born out of real-life clinical practice, not an engineering lab."
 
Cambridge Heartwear's Heartsense monitor is the only wirelessly chargeable heart health device on the market that uses real-time, pulse oximetry and multiple ECG inputs. When using the device, patients control and own their own heart data. Should they choose to, patients can also allow the device to securely acquire and transmit their real-time data to their physician. The platform allows patient's data to be shared with physicians the moment activity is started.
 
The AI healthcare sector is one of the fastest growing markets that virtually pays for itself. Unlike other healthcare verticals that require investments, AI is autonomous in generating revenue and year over year growth. In 2014, AI healthcare was valued at $600 million; by 2021, the AI health market is expected to reach $6.6 billion, which is a compound annual growth rate of 40 percent.
 
The Cambridge Heartsense monitor is already undergoing clinical trials among top-tier athletic organizations in the UK and the U.S. It was recently awarded on PwC's List of Most Innovative and Disruptive New Companies in the U.K. The company is also providing Heartsense monitors to communities in India and Africa to help prevent heart disease and stroke amongst patients. The device will be available on the market in early 2019. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-12-14 09:46:00 [updated_at] => 2018-12-14 09:50:03 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["301046","304193","299739","285594","300075","284024","303655","284243","283959","303607","304247","303994","300325","299507","293406","283958","289755","303895"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [2] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 305978 [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":"Johnson & Johnson","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 180989 [primary_image_old] => [slider_image_id] => 180989 [banner_image] => 0 [title] => J&J, Apple Seek to Improve AFib Outcomes [short_title] => [summary] => Companies to collaborate to assess impact of wearable technology on earlier detection of AFib, improved diagnosis, and patient outcomes. [slug] => jj-apple-seek-to-improve-afib-outcomes [body] => Johnson & Johnson has announced that Janssen Pharmaceuticals Inc., member of the Johnson & Johnson Family of Companies, entered into a research study in collaboration with Apple Inc. to investigate whether a new heart health program using an app from Johnson & Johnson in combination with Apple Watch’s irregular rhythm notifications and ECG app can accelerate the diagnosis and improve health outcomes of the 33 million people worldwide living with atrial fibrillation (AFib), a condition that can lead to stroke and other potentially devastating complications. In the U.S. alone, AFib is responsible for approximately 130,000 deaths and 750,000 hospitalizations every year.
 
The study aims to analyze the impact of Apple Watch on the early detection and diagnosis of AFib, and the potential to improve outcomes including the prevention of stroke. A multi-year research program will be launched later in 2019. This large-scale program will occur in the U.S. only, and will be designed as a pragmatic randomized controlled research study for individuals age 65 years or older.
 
The study’s goals include:  
“We’re excited about the potential of common, wearable technology to aid in the earlier detection and prevention of a frequent cause of stroke,” said Paul Stoffels, M.D., vice chair of the executive committee and chief scientific officer, Johnson & Johnson. “Too many people living with AFib are unaware of their risk, and earlier detection, diagnosis and treatment of AFib could significantly improve outcomes. Based on the insights generated through this research program, we may be able to develop new ways to detect other health conditions earlier in the future that also exhibit measurable physiological symptoms.”
 
“Through Apple Watch people have been able to learn more about their heart health, including discovering they have AFib. This kind of information empowers customers to follow up with the right treatment or even better, implement healthy habits aimed at prevention,” said Jeff Williams, chief operating officer, Apple Inc. “We’re excited to work with Johnson & Johnson, a leader in the medical community, as we learn about the impact Apple Watch can have in delivering better health outcomes.”
 
Johnson & Johnson’s recent mSTOPs (mHealth Screening to Prevent Strokes) study demonstrated that earlier screening leads to increased AFib detection. “Utilizing wristwatch-based optical heart sensor and ECG monitoring is a logical evolution of this research and may also lead to increased AFib diagnosis and improved clinical outcomes for patients,” said Paul Burton, M.D., Ph.D., FACC, vice president, medical affairs, internal medicine, Janssen Scientific Affairs, LLC.
 
“This collaboration brings together Johnson & Johnson’s depth of expertise and long heritage in treating cardiovascular disease with Apple’s experience in utilizing cutting-edge technologies to improve the lives of consumers. Ultimately, we hope to improve the treatment of cardiovascular disease, and identify ways to prevent it.” [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2019-01-17 09:42:00 [updated_at] => 2019-01-17 09:43:50 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["300443","289758","299472","302033","305381","301830","299952","289745","302205","304505","300397","302922","296472","299802","289752","289718","303896"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [3] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 306112 [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":"Abbott Laboratories","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 181117 [primary_image_old] => [slider_image_id] => 181117 [banner_image] => 0 [title] => FDA Approves Abbott's New TactiCath Contact Force Ablation Catheter [short_title] => [summary] => Abbott is helping more physicians integrate ablation with 3D mapping to advance the treatment of people with atrial fibrillation. [slug] => fda-approves-abbotts-new-tacticath-contact-force-ablation-catheter [body] => Abbott today announced U.S. Food and Drug Administration (FDA) approval of the TactiCath Contact Force Ablation Catheter, Sensor Enabled, a new ablation catheter designed to help physicians accurately and effectively treat atrial fibrillation (AFib). The approval further expands Abbott's portfolio of cardiac ablation tools that integrate with the company's EnSite Precision cardiac mapping system to help physicians develop more precise images of the heart during cardiac ablation procedures.
 
Similar to Abbott's other sensor-enabled mapping and ablation treatment catheters, TactiCath (Sensor Enabled) SE delivers more precise images of the heart overlaid with real-time electrical activity information. The catheter also utilizes the advanced ergonomic design found in the company's FlexAbility ablation catheter for superior reach and maneuverability during cardiac ablation procedures.
 
"Cardiac ablation has become a front-line therapy in the fight against conditions like atrial fibrillation in part because of improvements to the technology available today," said Roger Winkle, M.D., an electrophysiologist at Sequoia Hospital in Redwood City, Calif., and one of the first physicians to treat patients with the newly FDA-approved catheter. "The Abbott TactiCath SE ablation catheter represents one of those major improvements, and offers an incredibly powerful, yet easy to use, combination of advanced technologies to improve ablation procedures."
 
Technological Advancements in Cardiac Ablation 
One of the most common cardiac arrhythmias in the world, AFib can affect how efficiently the heart pumps blood through the body, causing symptoms such as dizziness, shortness of breath or lightheadedness. The condition can also increase a person's risk of stroke. To treat conditions like AFib, physicians can use ablation catheters to scar tissue in the heart that is generating abnormal electrical signals and disrupting a patient's natural heartbeat. As the number of patients receiving cardiac ablation therapy worldwide has grown, Abbott has prioritized ablation technology that adds efficiency and accuracy to ablation procedures. Abbott cardiac ablation technology is currently used to treat patients in more than 84 countries worldwide.
 
Not all ablation technology is the same, however. Physicians have begun exploring the use of new tools such as "contact force" technology during ablation procedures to help them avoid applying too much pressure to heart tissue (resulting in complications) or insufficient pressure (which may reduce the effectiveness of the procedure). In addition, Abbott has also invested in technology to improve the accuracy of cardiac mapping to support cardiac ablation procedures.
 
Over the last two years, Abbott has expanded offerings within its electrophysiology portfolio to drive new growth and build on the company's leadership. In addition to new clinical trials to further build clinical evidence surrounding cardiac ablation, the company has also launched the Advisor HD Grid Mapping Catheter, Sensor Enabled, and the FlexAbility Ablation Catheter, Sensor Enabled.
 
"TactiCath SE directly supports our goal of supporting fast, effective and safe cardiac ablation procedures," said Srijoy Mahapatra, M.D., FHRS, medical director of Abbott's Electrophysiology business. "As more physicians turn to cardiac ablation to treat AFib, Abbott's goal is to equip them with the most advanced ablation catheters combined with the most advanced cardiac mapping on the market." [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2019-01-21 09:18:00 [updated_at] => 2019-01-21 09:25:04 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["305910","305696","300780","300499","300283","299288","290449","290175","289559","296226","305313","302016","300250","302305","302922","296562","304399","303313","299802","304100"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [4] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 306548 [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":"Globe Newswire ","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 181624 [primary_image_old] => [slider_image_id] => 181624 [banner_image] => 0 [title] => Medtronic to Acquire EPIX Therapeutics, Expanding Its Cardiac Ablation Portfolio [short_title] => [summary] => The DiamondTemp ablation system represents a disruptive RF innovation. [slug] => medtronic-to-acquire-epix-therapeutics-expanding-its-cardiac-ablation-portfolio [body] => Medtronic plc has entered into a definitive agreement to acquire EPIX Therapeutics Inc., a privately-held medical device company that designs and manufactures a novel, catheter-based, temperature-controlled cardiac ablation system for the treatment of patients with cardiac arrhythmias (irregular heartbeats), including atrial fibrillation (AF). When completed, the EPIX acquisition will expand the Medtronic cardiac ablation portfolio to offer physicians a comprehensive suite of tools to treat patients with cardiac arrhythmias.
 
EPIX's flagship technology, the DiamondTemp ablation system, is a unique closed-loop, temperature-controlled system that provides physicians with improved feedback and control during an ablation procedure. The DiamondTemp system uses radiofrequency (RF) energy (heat) to create scar tissue in the heart and complements the Medtronic cryoballoon technology that uses cryo energy (cold) to isolate the pulmonary veins (PVI).
 
The DiamondTemp system received CE Mark in Europe in 2017 and is limited to investigational use in the U.S. The DIAMOND-AF trial, which completed enrollment in Oct. 2018, will support approval of the DiamondTemp system in the U.S. for patients with symptomatic paroxysmal AF (AF that starts and stops intermittently). Additionally, the DIAMOND-AF II trial, which is currently enrolling patients, is evaluating the DiamondTemp system in patients with persistent AF (AF that continues for long periods of time).
 
"The DiamondTemp ablation system stands out from other RF ablation technologies because of the real-time temperature control via rapid power modulation. This results in shorter procedure times and higher confidence in lesion quality," said Atul Verma, M.D., Southlake Regional Health Center in Newmarket, Canada, and global principal investigator for the DIAMOND-AF II study. "I've had the pleasure of working with EPIX to design the DIAMOND-AF II trial and I look forward to continuing that work with Medtronic."
 
"The DiamondTemp cardiac ablation system represents leapfrog technology in the RF cardiac ablation space, a segment of the market where we haven't previously participated," said Rebecca Seidel, vice president and general manager of the Atrial Fibrillation Solutions division, which is part of the Cardiac and Vascular Group at Medtronic. "When combined with our existing leading cryoballoon technology, we expect to provide physicians with a complete portfolio of best-in-class cryo and RF systems."
 
The EPIX acquisition is expected to close in Medtronic's fourth fiscal quarter, which runs January 26 to April 26, 2019, subject to the satisfaction of certain customary closing conditions. EPIX is currently pre-revenue, and although the acquisition is expected to be dilutive to Medtronic's near-term adjusted earnings per share, Medtronic intends to offset the dilution. The transaction is expected to meet Medtronic's long-term financial metrics for acquisitions. Additional terms of the transaction were not disclosed.
 
The DiamondTemp ablation system is a temperature-controlled, irrigated RF ablation system for treating patients with AF. The DiamondTemp system is a closed-loop system with open irrigation and high-resolution electrograms, providing physicians with improved feedback and control during the ablation procedure which may improve AF treatment success. 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