Updated with information from an Abbott spokesperson. The FDA today issued a Class I recall label for the safety notice Abbott (NYSE:ABT) issued for its MitraClip device over issues in which the clip delivery system could not be detached from the clip due to a malfunction. Class I recall designations, the agency’s most serious classification of recall, […]
Cardiovascular
Welcome to MassDevice's Cardiovascular Hub, your resource for the latest news in cardiac implants, structural heart, heart valves, stents and more. Stay informed about the innovations and business news shaping the cardiovascular device industry.
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Here are top cardiology features from MassDevice and its sister publications (and scroll down to read the latest cardiology device news from MassDevice):
+ LVADs save lives: So why aren’t more available?
+ How Medtronic uses nitinol to improve the structure and effectiveness of heart devices
+ How Abbott designed the world’s first dual-chamber leadless pacemaker system
+ J&J used RWE for expanded indications — and you can, too
+ 7 cardiology startups you need to know
Latest Cardiology News
Japan approves the Sapien 3 heart valve from Edwards Lifesciences
Edwards Lifesciences (NYSE:EW) said today that the Japanese Ministry of Health, Labor & Welfare approved its Sapien 3 transcatheter aortic valve replacement. Irvine, Calif.-based Edwards said it expects to win reimbursement approval in Japan during the 2nd quarter and launch “immediately thereafter” with a full rollout complete by the end of the year. “We are pleased to be […]
Boston Scientific, Mayo Clinic reveal hush-hush development program
Boston Scientific (NYSE:BSX) and Mayo Clinic today revealed a 3-year-old development program that has about a dozen new products in the pipeline, including a centering catheter for replacement heart valves and a heart failure application for the Precision Spectra spinal cord stimulator. Four of the roughly 12 products in the hush-hush program, reportedly winnowed from a field of 50 […]
AliveCor unveils EKG-equipped Kardia Band for Apple Watch
AliveCor said today it is premiering the Kardia Band EKG-equipped band for Apple‘s (NSDQ:AAPL) Apple Watch, designed to provide diagnostic-grade electrocardiogram readings through a smartphone-connected app, as well as a significant update to the company’s existing EKG-monitoring app. The Kardia Band is a thin wrist band designed specifically for the Apple watch that returns single-lead EKG […]
UPDATE: FDA panel OKs Abbott’s Absorb stent
UPDATED March 16 with comments from panel members. An FDA advisory panel recommended approval for the Absorb bioresorbable stent made by Abbott (NYSE:ABT). The Circulatory Devices panel voted 9-1 on safety, 10-0 on efficacy and 9-0, with one abstention, on the risk-benefit profile for the Absorb device, a coronary scaffold that’s designed to elute the drug everolimus […]
Biotronik’s BioMonitor 2 hits U.K., Ireland
Biotronik said today it launched its BioMonitor 2 subcutaneous insertable cardiac monitor in the U.K. and Ireland. The BioMonitor 2 device is designed for remote monitoring of patients with atrial fibrillation, syncope, bradycardia and tachychardia, Biotronik said. The device uses Biotronik’s ProMRI technology and is approved for full-body MRI scans at 1.5 and 3 tesla […]
Arterys raises $12m Series A round from MR-based vascular imaging
Arterys said today that it raised a $12 million Series A round for the MR-based vascular imaging system it’s developing. The San Francisco-based company said its system uses data from a 10-minute MRI chest scan to compute blood flow information with “deep learning” and artificial intelligence technology. Available to researchers now, the system is expected […]
Mass General researchers regenerate working heart muscle in decellularized human hearts
Researchers at Massachusetts General Hospital have regenerated functional heart muscle in a decellularized human heart. The donated hearts used in the study were stripped of components that would generate an immune response, and the regenerated tissue was generated from induced pluripotent stem cells, which the researchers said could come from a potential recipient. Investigators said […]
Teleflex recalls Arrow intra-aortic balloon pumps
Teleflex (NYSE:TFX) said today that it’s recalling nearly 50,000 of its Arrow International intra-aortic balloon pump catheters due to the risk of the sheath body detaching from its hub, after 13 adverse event reports including 6 serious injuries and 1 death. If the sheath body detaches from the hub, the patient may lose blood through the […]
Boston Scientific wins FDA nod for 1st open-irrigation ablation catheter
Boston Scientific (NYSE:BSX) yesterday said the FDA approved its Blazer OI ablation catheter, marking the 1st time the medical device maker will put an open-irrigated catheter for treating Type I atrial flutter on the U.S. market. The company also said it won CE Mark approval in the European Union for the IntellaTip MiFi OI catheter for use in all cardiac […]
Structural heart: Nobles Medical, HeartStitch tout cardiac suture procedures
Structural heart focused HeartStitch and Nobles Medical today touted separate procedures utilizing cardiac sutures with the company’s Hearstitch ST and Noblestitch EL devices. Nobles Medical Tech said that the NobleStitch EL device was used in the 1st percutaneous ASD closure and ASA repair and remodeling without the use of an implantable device. The NobleStitch EL device […]