Neovasc (NSDQ:NVCN) said today that its Reducer device designed for treating refractory angina was used in its first procedure in the US. The Reducer system is designed to alter blood flow in the heart’s circulatory system to increase perfusion of oxygenated blood to ischemic areas of heart muscle, and can be placed in a minimally invasive transvenous […]
Bay Labs wins FDA clearance for AI-based echocardiogram analysis
Bay Labs has received 510(k) clearance from U.S. FDA for use of its EchoMD AutoEF software product to provide fully automated clip selection and calculation of left ventricular ejection fraction (EF), the San Francisco–based company said today. The EF is the percentage of blood leaving a heart each time it contracts. Bay Labs in its news release […]
Newly formed pVAD dev Supira Medical raises $16m
Medtech incubator Shifamed said this week that its newly formed portfolio company Supira Medical has raised $15.5 million in a new round of financing. The round was led by The Capital Partnership and joined by Cormorant Asset Management and Shifamed Angels, the Campbell, Calif.-based incubator said. The round officially closed on April 25. Supira Medical […]
LivaNova wins FDA nod for Memo 4D mitral annuloplasty ring
LivaNova (NSDQ:LIVN) said today it won FDA 510(k) clearance for its Memo 4D semi-rigid mitral annuloplasty ring, and said that the device has been used in its first commercial procedure. The Memo 4D mitral annuloplasty ring is a next-generation device designed for treating patients with mitral regurgitation, and is available in sizes from 24 mm to […]
Venus Medtech launches Venus pulmonary valve implant
Chinese heart valve maker Venus Medtech said today it launched its Venus P-Valve self-expanding pulmonary valve implant in Canada, touting that the first procedures with the valve have been performed in the region. The Venus P-Valve was designed for percutaneous use in native right ventricular outflow tracts, the Hangzhou-baesd company said, and is intended for patients who […]
Medtronic warns on external pacemaker issues
Medtronic (NYSE:MDT) has released an urgent field safety notice warning of issues with a subset of its model 53401 single chamber external pacemakers in which the device may experience an unexpected power on reset. The Fridley, Minn.-based company said that the issue is due to an initial version of the firmware for the device which allowed […]
Researchers deliver cardiac stem cell therapy in preclinical trial using refillable patch
Researchers have developed a small device designed to halt the effects of a heart attack by delivering a stem cell therapy directly to damaged cardiac tissue. In a study published in Nature Biomedical Engineering, researchers from Harvard University, the Massachusetts Institute of Technology, the National University of Ireland Galway and Trinity College Dublin reported that the […]
How you can control lab-grown heart cells with a remote control light
University of California San Diego researchers have created a technique that speeds up and slows down human heart cells that are being grown in a dish on command by shining light on them and varying the intensity. The heart cells are being grown in graphene which turns light into electricity, a more realistic environment that […]
LivaNova wins Japanese nod for Perceval aortic valve
LivaNova (NSDQ:LIVN) said today it won approval from Japan’s Ministry of Health, Labour and Welfare for its Perceval sutureless aortic heart valve designed to treat aortic valve disease. The London-based company claims that the lack of suturing allows the super-elastic Perceval valve to achieve optimal effective orifice area, resulting in “excellent hemodynamics.” LivaNova said procedures utilizing […]
FDA labels IABP recall for Getinge’s Maquet, Datascope as Class I
The FDA today labeled a select recall of Getinge‘s (PINK:GETI B) Datascope and Maquet Cardiosave hybrid intra-aortic balloon pumps over issues related to fluid seepage and corrosion as Class I. A Class I recall is the federal watchdog’s most serious class of recall, indicating the potential for serious injury or death. The Cardiosave hybrid intra-aortic balloon pump is designed […]
Medtronic can’t slip whistleblower’s CRM suit
Medtronic (NYSE:MDT) must face a whistleblower’s lawsuit accusing it of running a kickbacks scheme to encourage doctors to implant its cardiac rhythm management devices. Plaintiff Cathleen Forney worked for Fridley, Minn.-based Medtronic for 16 years until she was fired from her role as a district service manager for the cardiac & vascular division in 2012, […]
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