JenaValve Technology announced that it raised $50 million in equity financing as it develops and manufactures the JenaValve pericardial transcatheter aortic valve replacement (TAVR) system for treating aortic valve disease. Bain Capital Life Sciences led the funding round, while Andera Partners, Gimv, Legend Capital, NoMed Management, RMM, Valiance Life Sciences and VI Partners all participated, […]
8 types of FDA-approved devices that treat the heart
Just starting to learn about all of the medical devices out there for treating cardiovascular diseases? The U.S. FDA has a good, basic roundup on its website of the most common types of cardiovascular devices it regulates. Go to our sister site Medical Design & Outsourcing to read the list, along with the FDA’s descriptions.
CHF Solutions secures distribution arrangement in central Europe
CHF Solutions (NSDQ:CHFS) announced today that it initiated distribution agreements with Neucomed Group and its affiliates to cover Germany, Austria and Switzerland. With the new distribution agreements, Eden Prairie, Minn.–based CHF Solutions is further expanding its commercial presence in Europe, as the company now has distribution partnerships covering 13 different countries across the globe, according to […]
FDA authorizes use of Caption Health’s AI software to capture heart images via ultrasound
The FDA announced today that it has authorized the marketing of Caption Health’s Caption Guidance software for assisting in the acquisition of cardiac ultrasound or echocardiography images. Caption Guidance is an accessory to compatible diagnostic ultrasound systems designed to use artificial intelligence to help capture images of a patient’s heart that are of acceptable diagnostic […]
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 […]
CardioFocus seeks PMA supplement to launch HeartLight X3 endoscopic ablation system
CardioFocus is seeking a PMA supplement with FDA so that it can launch its next-gen HeartLight X3 endoscopic ablation system in the U.S. The move comes more than 10 months after Marlborough, Mass.–based won a CE Mark in Europe for the device, which is used to treat AFib. CardioFocus plans to launch HeartLight X3 in […]
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 […]
Cardiac Science issues urgent field safety notice for some AED devices
Cardiac Science issued an urgent field safety notice to announce a voluntary recall of its G3 Elite automated external defibrillator (AED) devices. The Deerfield, Wis.-based company said in the notice that it received field reports saying that its G3 Elite devices’ “rescue ready” status indicator displayed red and the service LED was illuminated. After investigating […]
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 […]
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