Bardy Diagnostics says Seattle-area health providers are using its Carnation ambulatory monitor (CAM) patch to measure QT segments in COVID-19 patients prescribed hydroxychloroquine (HCQ) experimentally. Hospitals across the city in their protocals have slated the local company’s CAM patch for use monitoring cardiac rhythms after coronavirus patients on HCQ are discharged from the hospital, as […]
Impulse Dynamics appoints medical director
Cardiac contractility modulation (CCM) therapy developer Impulse Dynamics announced that it is appointing Dr. Ishu Rao as its medical director. Rao previously spent 17 years in a clinical practice treating heart failure patients, with a focus on interventional therapies, according to a news release. He received his cardiology training at Harbor-UCLA Medical Center in Torrance, […]
Medtronic recall of HeartWare HVAD system battery charger is Class I
The FDA has labeled a Medtronic (NYSE:MDT) HeartWare HVAD system battery charger as Class I — it’s most serious level. A notice out March 9 from the FDA said that the Fridley, Minn.-based medtech giant recalled 5,489 total battery charger devices due to the potential for an HVAD system user to mistakenly insert the charger’s AC […]
Abbott wins CE Mark for FlexNav delivery system
Abbott (NYSE:ABT) announced today that it won CE Mark approval in Europe for the FlexNav delivery system for its Portico transcatheter aortic valve implantation (TAVI) system. The Abbott Park, Ill.-based company’s FlexNav delivery system is designed to offer another tool for doctors to treat patients requiring a transcatheter aortic valve implant by incorporating stability, predictability and […]
Aria completes $31m Series B for its pulmonary hypertension treatment device
Pulmonary arterial hypertension (PAH) treatment developer Aria CV announced today that it completed a $31 million Series B financing round. The proceeds from the round, led by private equity and venture investor Xeraya Capital, are earmarked for funding St. Paul, Minn.–based Aria CV’s first U.S. clinical study. Aria CV’s early feasibility investigational study is set […]
Aria CV wins breakthrough nod for pulmonary arterial hypertension device
Aria CV announced that it won FDA breakthrough device designation for its pulmonary hypertension (PH) system for treating pulmonary arterial hypertension (PAH) that can lead to heart failure. The implanted system is designed to restore the benefits of a healthy, elastic pulmonary artery, according to a news release. The restoration should lead to reduced cardiac […]
CMS considers extending Medicare coverage for heart devices
The Centers for Medicare and Medicaid Services (CMS) may extend coverage for artificial hearts and ventricular assist devices (VADs). Currently, Medicare covers artificial hearts for beneficiaries enrolled in a CMS-approved clinical study, a status that hasn’t been updated since 2008. Artificial heart-maker SynCardia wrote a letter last year to CMS asking it to extend coverage […]
Abbott wins FDA breakthrough nod for ventricular assist system
Abbott (NYSE:ABT) announced today that it won FDA breakthrough device designation for its in-development fully implantable left ventricular assist system (Filvas). According to a news release, left ventricular assist devices are implanted into the body and powered using an external battery pack or charging port. Abbott’s fully implantable device would require no external components, offering more […]
MIT engineers have created a bionic ‘heart’
Massachusetts Institute of Technology announced that engineers at the institute, along with others elsewhere, have collaborated to develop a bionic “heart” designed to offer a more realistic model for testing artificial valves and other devices. According to a report from MIT News, the device is a real biological heart which had its tough muscle tissue replaced […]
FDA OKs new clinical trial for Abbott’s Amplatzer stroke prevention device
FDA has approved a clinical trial that will pit Abbott’s Amplatzer Amulet stroke prevention device against a newer class of blood thinners that are the present standard of treatment. Officials at Abbott (NYSE:ABT) think data from the new Catalyst trial could alter clinical practice, eliminating the need for some people with atrial fibrillation to take blood […]
Abbott appears to be ahead in the TMVR race
Abbott (NYSE:ABT) announced today that its Tendyne transcatheter mitral valve implantation system has won CE Mark approval in Europe — touting the approval as a first. Industry insiders consider transcatheter mitral valve replacement as the next big thing after transcatheter aortic valve replacement (TAVR), with a potentially significant market for TMVR. The CE Mark for Tendyne […]
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