Hypertrophic cardiomyopathy (HCM) might not be the talk of the town in the world of cardiology medical devices, but the condition has a devastating effect on a large number of lives, particularly in the case of early disease onset. San Francisco-based Viz.ai Inc. has won a de novo from the U.S. FDA for its algorithm for identification of patients at risk of HCM, the aptly named Viz HCM, a product the company believes will not only save lives but may save the U.S. health care system a large amount of money as well.

The $31.4 million investment Capstan Medical Inc. recently received in its Series B funding round will allow the company to make headway in its efforts to use a catheter-based, robotic delivery platform to treat patients with mitral and tricuspid valve disease. With heart disease a leading cause of death globally and cardiac procedures remaining highly invasive and filled with complications, Capstan is working to provide patients with safer, less invasive alternative.

Acorai AB received a U.S. FDA breakthrough device designation for its Heart Monitor, a noninvasive intracardiac pressure monitoring device for patients with heart failure. The Acorai Heart Monitor can estimate diastolic pulmonary artery pressure, systolic pulmonary artery pressure and mean pulmonary artery pressure in patients with Stage C heart failure who have been referred for hemodynamic monitoring.

Lush vegetation is great for a gardener, but alarming for a cardiologist. For them, the news that Angiodynamics Inc. received U.S. FDA breakthrough device designation for its Angiovac system to remove vegetation from the right heart is surely cheering. Right heart vegetations--masses of fibrin, platelets and infectious pathogens--are indications of serious infective endocarditis.

Boston Scientific Corp. has managed its Polarx device to another regulatory approval, this time a nod from the U.S. FDA, giving the company access to one of the world's premier markets. The news comes four months after the company obtained a CE mark for the device, opening the door to two jumbo markets in a move the company hopes will ensure the device will provide solid returns on its investment.

Peijia Medical Co. Ltd. reported the implant of its Taurustrio transcatheter aortic valve replacement (TAVR) system in a first patient as part of a multi-center trial getting one step closer to launching the first TAVR system for aortic regurgitation (AR) in China.

Transcatheter aortic valve replacement (TAVR) devices are all the rage for treatment of aortic valve disease, but that doesn’t mean valve reconstruction via the so-called Ozaki procedure has been consigned to the pages of medical history. The U.K.’s National Institute for Health and Care Excellence has recommended that trusts in the U.K. health system use this procedure only in clinical trials at least for the time being, although the agency noted that the Ozaki procedure allows the patient to sidestep the need for long-term antithrombotic therapy, a big selling point for patients and clinicians alike.

Genesis Medtech Group received marketing approval from China’s National Medical Products Administration for its laparoscopic surgical device called Artisential, which helps surgeons in precision surgery. The approval not only adds another market in which the device is available but will allow Genesis to expand its reach in China.