FDA approves Abbott ’ s HeartMate 3 as a destination therapy
Abbott (NYSE:ABT) said today it won FDA approval for its HeartMate 3 left ventricular assist device, now approved as a destination therapy for patients with advanced heart failure.
With the approval, the Chicago-based company said that the device can now be used in patients not eligible for a transplant as a life-long implant.
“We partner with physicians to holistically develop therapies that benefit patients and achieve better outcomes. The unique design of the HeartMate 3 LVAD—with its Full MagLev technology—takes an established innovation and improves upon it in meaningful ways to help people with advanced he...
Source: Mass Device - October 19, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Abbott Source Type: news
Judge pares claims in Bard IVC bellwether
A federal judge in Arizona yesterday pared some claims in the third bellwether case involving inferior vena cava filters made by Becton Dickinson (NYSE:BDX) subsidiary C.R. Bard, as the trial entered its 11th day.
It’s the fourth bellwether in the multi-district litigation over the IVC devices, which are designed to prevent blood clots from passing through the body’s largest vein into the heart and lungs. In the first case to go to trial, a federal jury in Phoenix found for plaintiff Sherr-Una Booker, awarding $3.6 million in damages.
Bard prevailed in the second bellwether trial, with the jury finding that t...
Source: Mass Device - October 3, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Featured Legal News Product Liability Vascular bectondickinson crbard Source Type: news
InfoBionic drums up $50m for MoMe Kardia remote heart monitor
InfoBionic said today that it raised another $50 million for its wireless remote cardiac monitor.
Boston-based InfoBionic said Eagle Investments, Excel Venture Management, Safeguard Scientifics, Blue Cross Blue Shield of Massachusetts subsidiary Zaffre Investments and Blue Cross and Blue Shield of Kansas all participated in the round.
The company sells the MoMe Kardia device, a remote, wireless outpatient system for monitoring & diagnosis of cardiac arrhythmias. It won 510(k) clearance from the FDA in 2015. Last month, InfoBionic inked a deal giving exclusive U.S. distribution rights for the MoMe Kardia system to Bi...
Source: Mass Device - September 11, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Funding Roundup Patient Monitoring Wall Street Beat InfoBionic Source Type: news
Biotronik Enters into Distribution Agreement with InfoBionics
Biotronik has become the exclusive US distributor for InfoBionic's MoMe Kardia external cardiac diagnostic monitor.
The device benefits patients suspected of experiencing cardiac arrhythmias.
“When we’re looking at partners - we’re asking ourselves - are these partners able to do the three main things that are important to us,†Rupa Basu, Senior Vice President of Marketing, Corporate Accounts and Strategy, at Biotronik, told MD+DI. “The first thing is, is it going to improve the patient’s expe...
Source: MDDI - September 7, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Cardiovascular Source Type: news
Biotronik to distribute InfoBionic monitor in U.S.
Biotronik has landed exclusive U.S. distributorship for InfoBionic’s MoMe Kardia external cardiac diagnostic monitor.
MoMe Kardia was designed to increase early detection and diagnosis of cardiac arrhythmias by providing physicians with the ability to access near real-time electrocardiographic data. Monitoring can also uncover patients at higher risk of sudden cardiac death.
Get the full story on our sister site, Medical Design & Outsourcing.
The post Biotronik to distribute InfoBionic monitor in U.S. appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - August 28, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Business/Financial News Cardiac Assist Devices Distribution Biotronik InfoBionic Source Type: news
Bankers in their twenties suffering more heart attacks, doctors warn
These unlikely patients regularly present themselves with two types of heart conditions: cardiac arrhythmia and myocarditis. (Source: the Mail online | Health)
Source: the Mail online | Health - August 6, 2018 Category: Consumer Health News Source Type: news
The future of Abbott ’ s electrophysiology business
At DeviceTalks Minnesota 2018, medtech veteran Michael Pederson provided an inside look at the Abbott-St. Jude Medical merger and what’s ahead for Abbott’s cardiovascular technologies.
Pederson tracked his career from a formative stint at HP to his current role as SVP of cardiac arrhythmias and heart failure at Abbott (NYSE:ABT).
Check out his keynote address with DeviceTalks founder Brian Johnson.
To learn more from the brightest minds in medtech, don’t miss DeviceTalks Boston on Oct. 8-10
The post The future of Abbott’s electrophysiology business appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - July 30, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Business/Financial News Cardiovascular DeviceTalks Q&A Wall Street Beat Abbott DeviceTalks Boston DeviceTalks Minnesota Source Type: news
Johnson & Johnson hits the Big Apple with latest JLabs site
Johnson & Johnson (NYSE:JNJ) opened its latest life science incubator in New York City, the healthcare giant said today.
The 30,000-square-foot JLabs @ NYC is a collaboration between Johnson & Johnson Innovation, New York State and the New York Genome Center. Sited at the genome center in SoHo, the incubator is home to 26 startups and has room for four more, New Brunswick, N.J.-based J&J said.
“Johnson & Johnson has deep entrepreneurial roots in New York and we are pleased to see our unique JLabs model applied in this rich ecosystem to foster the creation of new healthcare innovations that have the p...
Source: Mass Device - June 21, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Funding Roundup Research & Development johnsonandjohnson Source Type: news
Philips acquires Remote Diagnostic Technologies
Royal Philips (NYSE:PHG) said today it acquired U.K.-based Remote Diagnostic Technologies for an undisclosed amount.
Remote Diagnostic Technologies develops cardiac therapy, data management and monitoring solutions for the pre-hospital market, and has a portfolio of connected emergency care solutions that Amsterdam-based Philips said will complement its therapeutic care biz.
“We are committed to investing in and expanding our resuscitation and emergency care offering, and with the acquisition of RDT we can boost our capabilities and portfolio in this vital area of healthcare. With its focus on the pre-hospital mark...
Source: Mass Device - June 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Mergers & Acquisitions Patient Monitoring royalphilips Source Type: news
Philips to acquire EPD solutions in $293m upfront deal
Royal Philips (NYSE:PHG) said today it inked a deal to acquire image-guided cardiac arrhythmia treatment dev EPD Solutions for $293 million (EU €250 million) upfront with a possible additional $246.2 million (EU €210 million) upon completion of the deal based on certain milestones.
EPD Solutions produces cardiac imaging and navigation systems designed to aid electrophysiologists in navigating the heart through a detailed 3D image of the cardiac anatomy, Amsterdam-based Philips said. The system is also designed to identify the location and orientation of catheters during the diagnostic and therapeutic procedures for c...
Source: Mass Device - June 5, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Mergers & Acquisitions royalphilips Source Type: news
Philips Bets Big on Image-Guided Therapy with Latest Acquisition
Royal Philips is seeking to expand its image-guided therapy solutions with the acquisition EPD Solutions. Philips is set to acquire the Tortola, British Virgin Islands-based company for about $292 million upfront. The deal could close in July, Philips said.
EPD’s cardiac imaging and navigation system has received CE mark and is used in diagnostic and therapeutic procedures for cardiac arrhythmias. The system has not been given a nod from FDA and is currently under review by the agency.
Philips said its interventional imaging systems, such as Azurion, and EPD’s cardiac imaging and navigation system could more efficientl...
Source: MDDI - June 5, 2018 Category: Medical Devices Authors: Omar Ford Tags: Imaging Cardiovascular Source Type: news
Boston Scientific touts safety, effectiveness in Rhythmia mapping study
Boston Scientific‘s (NYSE:BSX) Rhythmia mapping system and catheter was found to be safe and effective in procedures to treat arrhythmias, according to a Healio summary of a newly released study from the company.
Researchers in the study examined 572 patients, with 519 patients undergoing procedures with the Rhythmia system and IntellaMap Orion catheter, according to the report. A total of 504 patients had a complete mapping procedure and were followed for one month post-procedure.
Findings from the study were presented at the EHRA 2018 meeting, according to Healio.
The primary endpoint of the trial was acute procedu...
Source: Mass Device - May 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Imaging Boston Scientific Source Type: news
New Cardiac Mapping Options for Complex Arrhythmias
CARLSBAD, Calif., May 8, 2018 /PRNewswire/ -- Acutus Medical®, a global heart rhythm technology company, today announced that the AcQMap® High Resolution Imaging and Mapping System has been utilized for the first time in U.S. patients. The company also revealed initiation of a new clinical study to evaluate the technology during atrial fibrillation retreatment ablation procedures in Europe and Canada.
"Enabling physicians to see complex, irregular arrhythmias in real-time should provide important new insights and enable truly personalized and individualized ablation therapy planning. We hope that this uniq...
Source: MDDI - May 9, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Imaging Source Type: news
Abbott Expands Cardiac Arrhythmias Portfolio with FDA Clearance of Advanced Mapping Catheter
ADVISOR HD GRID MAPPING CATHETER, SENSOR ENABLED FACILITATES IMPROVED DATA COLLECTION, SUPPORTING OPTIMAL TREATMENT FOR PATIENTS WITH COMPLEX CARDIAC ARRHYTHMIAS
FIRST-OF-ITS-KIND GRID CONFIGURATION IS DESIGNED TO CAPTURE DATA IN MULTIPLE DIRECTIONS T... Devices, Cardiology, FDA Abbott, Advisor, HD Grid Mapping Catheter, Arrhythmia, electrophysiology (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - May 3, 2018 Category: Pharmaceuticals Source Type: news
