PARIS – Carmat SA has closed an $11.8 million loan in the form of a government-backed loan from a French banking syndicate. In an environment made uncertain by the COVID-19 crisis, Carmat will be able to continue its clinical development program on its total artificial heart, undisturbed. “This financing facility contributes to securing our cash position and extends our financial visibility through to the third quarter of 2021,” Stéphane Piat, CEO of Carmat, told BioWorld.

The U.S. FDA cleared Alivecor Inc.'s Kardia AI V2 interpretive electrocardiogram (ECG) algorithm for use in its personal ECG app and devices. Currently, the Kardia line permits consumers to take a 30-second medical grade ECG at home and instantly see whether they are exhibiting symptoms of atrial fibrillation, bradycardia, tachycardia or have normal heart rhythm.

Medtronic plc's cryoablation could soon put drug therapy on ice in parts of the atrial fibrillation (AF) market, based on results of studies published in the New England Journal of Medicine (NEJM) and presented at the American Heart Association Scientific Sessions 2020.

Boston Scientific Corp. said it is initiating a global, voluntary recall of all unused inventory of the Lotus Edge aortic valve system, blaming complexities associated with the product delivery system. The Marlborough, Mass.-based company emphasized that the valve itself continues to achieve positive and clinically effective performance post-implant. However, because of the time and investment needed to develop and reintroduce a delivery system, the company believes it is necessary to retire the entire Lotus platform immediately.