Endologix Inc., of Irvine, Calif., has won approval from the U.S. FDA for its Alto abdominal stent graft system, the company’s next-generation Ovation system for polymer endovascular aneurysm repair (EVAR). The company plans to begin rolling out Alto initially to high-volume customers of its Ovation iX system, who are already skilled at using Ovation stent grafts.

Balloon catheters are in abundant use across the human vasculature. Thus, the January U.S. FDA draft guidance for angioplasty and specialty catheters captured a range of critical devices. However, Stephen Ferguson, of Bloomington, Ind.-based Cook Group Inc., cited several problems he saw with the draft, including that one of the specifications for balloon fatigue testing exceeds the level spelled out in an international standard adopted by the FDA.

TORONTO – Complain to your doctor about shortness of breath, chest pain or a rapid or irregular heartbeat and chances are you’ll end up on a treadmill to check for the presence of coronary artery disease or CAD. The conventional treadmill stress test is a time-consuming process that could change with patented, AI-driven sensor technology developed by Ottawa, Ontario-based Ausculsciences Inc. and bankrolled by US$10 million from investors anxious to see the CAD-det System approved for sale by the end of the year.

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.