Keystone Heart Ltd., of Caesarea, Israel and Tampa, Fla., scored a win in Europe after obtaining the CE mark for the Triguard 3 cerebral embolic protection (CEP) device. It is designed to minimize the risk of cerebral damage by deflecting embolic debris away from cerebral circulation during transcatheter aortic valve implantation (TAVI) and other transcatheter heart procedures. According to the company, the device is the only product with a CE mark designed to cover and protect all three major cerebral aortic arch vessels.

Campbell, Calif.-based startup Supira Medical Inc. scooped up $35 million in a series B financing led by Cormorant Asset Management. Also participating in the round were The Capital Partnership, 415 Capital, Amed Ventures and Shifamed Angels. The new capital is earmarked to advance the development and clinical evaluation of the company’s next-generation percutaneous ventricular assist device.

An artificial intelligence (AI) platform developed by Naperville, Ill.-based Physiq Inc. gave researchers a mean of 10.4 days warning of an impending heart failure exacerbation that would require hospitalization or an emergency department visit, according to a study published in Circulation – Heart Failure.

San Francisco-based startup Element Science Inc. has raised a massive financing in support of the first product that is part of its next-generation digital wearable platform. The $145.6 million series C financing is slated to support the company through clinical trial completion and commercial launch of its Jewel Patch Wearable Cardioverter Defibrillator.

PARIS – Vygon SA, of Ecouen, France, has acquired Advanced Perfusion Diagnostics SA (APD), a startup based in Lyon, France, that has developed Ikorus, a device that detects changes in visceral microvascular blood flow in the most critically ill hospital patients. Vygon did not disclose the financial details behind the agreement.

The U.S. FDA has given its nod to Novalung, a heart and lung support system from Fresenius Medical Care North America (FMCNA) for the treatment of acute respiratory or cardiopulmonary failure. The Waltham, Mass.-based company noted that Novalung is the first extracorporeal membrane oxygenation (ECMO) system to be cleared for more than six hours of use.

NATIONAL HARBOR, Md. – Berlin-based Biotronik SE & Co. reported new data from the BIOFLOW-V trial showing that its Orsiro ultrathin strut drug-eluting stent (DES) continued to outperform Abbott Laboratories’ Xience DES through three years’ follow-up.