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 eyes may be the window to the heart as well as the soul – particularly, to whether that heart is at risk of an infarct, researchers reported last week at the annual congress of the European Society of Human Genetics.
Medtronic plc received FDA premarket approval for its Onyx Frontier drug-eluting stent, an update to the company’s Resolute Onyx stent. The Frontier is designed for treatment of patients with coronary artery disease (CAD), a leading cause of death in the U.S. Medtronic expects the stent to receive CE mark shortly.
PERTH, Australia – Medtech newcomer Artrya Ltd. listed on the Australian Securities Exchange (ASX) in an AU$40 million (US$28.6 million) initial public offering to commercialize its software that analyzes heart computed tomography (CT) scans via artificial intelligence (AI) to better diagnose coronary artery disease.
Pulse Medical Imaging Technology (Shanghai) Co. Ltd. has raised more than $100 million in a series C funding round to accelerate the R&D, clinical trials and commercialization of its products. “Pulse plans to use the funds to accelerate the commercialization of its fractional flow reserve (FFR) estimating systems,” Xiaojie Lin, marketing director of Pulse, told BioWorld. FFR is a method to measure blood pressure and flow within a coronary artery to check on the possibility that the stenosis impedes oxygen delivery to the heart muscle.
Medtronic plc launched the newest product in its coronary portfolio, the Prevail drug-coated balloon (DCB) catheter, in Europe following CE mark approval. The device is intended for use during minimally invasive procedures to open narrowed or clogged arteries in patients with coronary artery disease.
Heartflow Holding Inc. is aiming to bring its noninvasive, artificial intelligence (AI)-based test for coronary heart disease to more doctors and patients via a merger with Longview Acquisition Corp. II. The deal, valued at an enterprise value of about $2.4 billion, is the latest in a steady stream of med techs queueing up to go public via a “blank check” special purpose acquisition company (SPAC) this year.
Cleerly Inc. snapped up $43 million in a series B fundraising round to develop artificial intelligence (AI)-enhanced imaging to better understand heart disease and more accurately project patient outcomes. Vensana Capital led the round with participation from the American College of Cardiology, Cigna Ventures, Dititx Partners, Lrvhealth (formerly Long River Ventures), New Leaf Venture Partners and returning investors.
Corvista Health Inc., a subsidiary of Toronto-based Analytics for Life Inc., reported closing on $65 million in series C equity financing, bringing total cash raised for a new cardiac diagnostics device to nearly $100 million. The Corvista system is described as noninvasive, point-of-care diagnostic system for coronary artery and other cardiovascular diseases.
Corvista Health Inc. has raised $65 million in a series C equity financing led by Ambix Life Science Fund I LP. The new funds are earmarked for ongoing research, product development and commercialization of the company’s noninvasive, point-of-care (POC) solution for rapid detection of heart disease. Joining Ambix in the round were Medventure Partners and several new and existing investors. With this latest infusion, Corvista has raised a total of nearly $100 million.
