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Cardiovascular

Abbott imaging catheter recall flagged as Class I by FDA

May 27, 2022 By Jim Hammerand

The FDA has identified the Abbott (NYSE:ABT) recall of its Dragonfly OpStar Imaging Catheter as a Class I recall. That’s the most serious level of a medical device recall, carrying the risk of serious injury or death. Five incidents, one injury and zero deaths were reported when Abbott initiated the recall on April 11. The […]

Filed Under: Blog, Cardiovascular, Catheters, Food & Drug Administration (FDA), Imaging, News Well, Recalls, Regulatory/Compliance, Vascular Tagged With: Abbott, FDA

Will Johnson & Johnson buy Boston Scientific?

May 27, 2022 By Chris Newmarker

Needham & Co. analyst Mike Matson today upgraded his rating of Boston Scientific (NYSE:BSX) shares to Buy, partly because he thinks it’s an acquisition target for Johnson & Johnson (NYSE:JNJ). Said Matson: “If JNJ decides to acquire a large medtech company, we believe that BSX could be a good fit.” BSX shares were up more […]

Filed Under: Business/Financial News, Cardiovascular, Featured, Mergers & Acquisitions, News Well, Wall Street Beat

FDA grants IDE for MedAlliance’s sirolimus-eluting balloon

May 26, 2022 By Sean Whooley

MedAlliance announced today that it received FDA investigational device exemption (IDE) for its Selution SLR drug-eluting balloon. Geneva, Switzerland-based MedAlliance designed its Selution SLR (sustained limus release) novel sirolimus-eluting balloon to provide a controlled sustained drug release, similar to a drug-eluting stent. Get the full story at our sister site, Drug Delivery Business News.

Filed Under: Cardiovascular, Drug-Device Combinations, Drug-Eluting Stents, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: FDA, MedAlliance

AccuPulse raises $10M Series A

May 25, 2022 By Sean Whooley

AccuPulse Medical Technology announced that it recently raised more than $10 million in a Series A funding round. Shenzhen Qianhai Capital led the funding round, with Shanghai Biomedical Industry Equity Investment Fund and Yuanbio Ventures jointly investing. AccuPulse develops electrophysiology technology designed as a one-stop solution to treat cardiac arrhythmias, especially atrial fibrillation. Its product […]

Filed Under: Business/Financial News, Cardiovascular, Catheters, Funding Roundup, Vascular Tagged With: AccuPulse

inHeart wins FDA clearance for 3D cardiac modeling software

May 24, 2022 By Sean Whooley

inHeart announced today that it received FDA 510(k) clearance for its inHeart Models software suite for cardiac modeling. France-based inHeart designed its inHeart Models software to enable the 3D visualization and analysis of anatomical structures for pre-procedural planning and intraprocedural use. FDA clearance allows for the expansion of the company’s commercial footprint in the U.S. […]

Filed Under: 510(k), Cardiovascular, Food & Drug Administration (FDA), Health Technology, Imaging, Regulatory/Compliance, Software / IT Tagged With: FDA, inHeart

FDA clears RapidAI’s pulmonary embolism triage platform

May 24, 2022 By Sean Whooley

RapidAI announced today that it received FDA 510(k) clearance for its Rapid PE Triage & Notification product. San Mateo, California-based RapidAI designed its Rapid PE Triage & Notification product for the fast identification and communication of suspected central pulmonary embolism (PE). According to a news release, Rapid PE Triage & Notification works in conjunction with […]

Filed Under: 510(k), Blood Management, Cardiovascular, Diagnostics, Digital Health, Food & Drug Administration (FDA), Health Technology, Regulatory/Compliance, Software / IT, Vascular Tagged With: FDA, RapidAI

Boston Scientific’s Acurate Neo2 valve performs well in studies

May 20, 2022 By Sean Whooley

Boston Scientific (NYSE:BSX) announced positive outcomes from studies of its Acurate Neo2 aortic valve system. Initial outcomes from the Neo-Align study of 170 patients who underwent transcatheter aortic valve implantation (TAVI) with Acurate Neo2 using a novel implant technique to attempt commissural alignment of the prosthetic and native valves demonstrated that commissural alignment can be […]

Filed Under: Cardiac Implants, Cardiovascular, Clinical Trials, Featured, Implants, News Well, Replacement Heart Valves, Structural Heart Tagged With: Boston Scientific, TAVI, tavr

Abbott reports positive data on heart valve therapies

May 19, 2022 By Sean Whooley

Abbott (NYSE:ABT) today announced clinical study data supporting its TriClip and Navitor heart valve treatment technologies. Data for the TriClip minimally invasive tricuspid heart valve repair device and Navitor next-generation transcatheter aortic valve implantation (TAVI) system were presented at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EuroPCR). Real-world outcomes from the […]

Filed Under: Cardiac Implants, Cardiovascular, Clinical Trials, Featured, News Well, Replacement Heart Valves, Structural Heart Tagged With: Abbott

Expect more heart and lung failure years after COVID, Abbott’s heart failure CMO says

May 18, 2022 By Jim Hammerand

Two years into the COVID-19 pandemic, we know more than ever about the SARS-CoV-2 virus and how quickly it moves to ravage the human body. What remains to be seen is how the virus — and perhaps more importantly, our immune system’s response to it — will affect the health of people long after infection, […]

Filed Under: Blog, Cardiovascular, Featured, News Well, Patient Monitoring, Respiratory, Structural Heart, Transplants Tagged With: Abbott, covid, COVID-19, heart failure, lung failure

Teleflex wins Health Canada nod for Manta vascular closure device

May 18, 2022 By Danielle Kirsh

Teleflex (NYSE:TFX) today announced its Manta vascular closure device received Health Canada approval. Wayne, Pennsylvania-based Teleflex designed the Manta biomechanics vascular closure device for large bore femoral arterial access site closure. “Our team has been working diligently to obtain this approval and were confident that Health Canada would recognize the benefits of the Manta device,” […]

Filed Under: Business/Financial News, Cardiovascular, Catheters, Regulatory/Compliance Tagged With: Teleflex

Study shows strong performance, improved outcomes with Medtronic Evolut TAVR

May 18, 2022 By Sean Whooley

Medtronic (NYSE:MDT) today announced positive results from a study of its Evolut transcatheter aortic valve replacement (TAVR) system. The Optimize PRO clinical study evaluated the self-expanding, supra-annular Evolut PRO and PRO+ TAVR platforms. Medtronic’s CoreValve Evolut R, CorValve Evolut PRO and Evolut Pro+ systems are indicated for the relief of aortic stenosis in patients with […]

Filed Under: Cardiac Implants, Cardiovascular, Clinical Trials, Featured, News Well, Replacement Heart Valves, Structural Heart Tagged With: Medtronic, tavr

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