Venus Medtech (Hangzhou) Inc. received the green light in China for its transcatheter pulmonic valve replacement (TPVR) system Venusp-Valve. It is a self-expanding TPVR product for the treatment of severe pulmonary regurgitation (≥3+) in patients after a congenital heart defects procedure with native right ventricular outflow tract.
Medtronic plc has entered a strategic collaboration with Cathworks Ltd. to expand the reach of Cathworks’ artificial intelligence (AI) guidance system for coronary artery disease management. Medtronic will invest up to $75 million and immediately begin co-promotion of the Ffrangio system on the U.S., European and Japanese market. As part of a separate agreement, Dublin-headquartered Medtronic will have the option to acquire Cathworks once certain undisclosed milestones are met.
Rainmed Medical Ltd. raised HK$146 million (US$19 million) in an initial public offering in Hong Kong. Its shares debuted at HK$5.60 and dropped as much as 15.38% to close at HK$5.28 on July 8, 2022, the first trading day. Jiangsu, China-based Rainmed Medical plans to use 80% of the proceeds to support the development and commercialization of its core products – a coronary angiography-derived fractional flow reserve (caFFR) system and a coronary angiography-derived index of microvascular resistance (caIMR) system.
The University of Central Florida (UCF) and Orlando Health are testing new medical technology designed to identify blood clots more quickly in surgery. The monitoring device consists of a small optical fiber that uses red blood cells to track the process of blood coagulation in patients so doctors can watch for life threatening blood clot formation.
Corvia Medical Inc. has closed $54 million in equity financing to support a confirmatory trial for its Interatrial Shunt Device, designed to reverse diastolic heart failure (HF), otherwise known as “preserved ejection fraction” (HFpEF), and which affects millions of Americans. This follows results of the largest randomized controlled trial of a device-based therapy published in February 2022, with a 45% reduction in HF events and a 55% greater improvement in patient quality of life.
Ceros Capital Markets and Peregrine Ventures evidently liked what they heard about Cordio Medical Ltd.’s Hearo voice app that can detect deterioration in patients with congestive heart failure (CHF), leading them to invest $18 million in the company’s latest venture funding round.
Shares in Acutus Medical Inc. (NASDAQ:AFIB) are trading 50% higher after the arrhythmia management company reported the launch of an expanded suite of its Acqcross left-heart access products. The Carlsbad, Calif.-based company received an expanded U.S. FDA clearance for its Acqcross Qx system for use with Natick, Mass.-based Boston Scientific Corp.’s Watchman left atrial appendage closure (LAAC) device.
The FDA has rejected Artrya Ltd.’s 510(k) application for its Salix coronary anatomy (SCA) software that analyzes heart computed tomography scans via artificial intelligence (AI) to better diagnose coronary artery disease. “The FDA has advised that the Artrya Salix product is not equivalent to the predicate device,” Artrya CEO John Barrington told BioWorld.
The U.S. Centers for Medicare & Medicaid Services (CMS) had covered transcarotid artery revascularization for patients at high risk of poor outcomes during carotid artery endarterectomy to correct for stenosis, but the agency recently expanded that patient population to those at standard surgical risk. The news was lauded by the Society for Vascular Surgery (SVS) as a solid development for patients, given that this procedure’s complication rates are in many instances lower than seen in conventional endarterectomy.
Less than three years after unveiling the first Sonovein device, Theraclion SA is launching its CE-marked, third-generation platform, Sonovein HD. This represents a new generation of robotics platform for noninvasive treatment of varicose veins. The new version integrates the acquisition and analysis of technical data during the procedure.
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