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 […]
Cardiovascular
Will Johnson & Johnson buy Boston Scientific?
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 […]
FDA grants IDE for MedAlliance’s sirolimus-eluting balloon
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.
AccuPulse raises $10M Series A
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 […]
inHeart wins FDA clearance for 3D cardiac modeling software
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. […]
FDA clears RapidAI’s pulmonary embolism triage platform
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 […]
Boston Scientific’s Acurate Neo2 valve performs well in studies
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 […]
Abbott reports positive data on heart valve therapies
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 […]
Expect more heart and lung failure years after COVID, Abbott’s heart failure CMO says
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, […]
Teleflex wins Health Canada nod for Manta vascular closure device
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,” […]
Study shows strong performance, improved outcomes with Medtronic Evolut TAVR
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 […]
