Edwards Lifesciences and Medtronic have struggled for supremacy for transcatheter aortic valve devices for several years, but two recent studies suggest the Edwards line of devices provide better outcomes. However, another study gave new life to the notion that TAVR devices are underutilized, signaling that there is plenty of market for both companies.
Oxford University startup Ultromics Ltd. has won the U.S. FDA's nod for its artificial intelligence (AI) image analysis system for diagnosing coronary artery disease. Called Echogo Core, the system is intended to serve as an aid to cardiologists in evaluating echocardiograms of patients referred with symptoms such as shortness of breath and chest pain. Ross Upton, co-founder and CEO of Ultromics, called the clearance a "watershed moment" for the company, which began developing its algorithm-based system in 2011 and was spun out of Oxford University in 2017. The next stage for the company is commercializing the product and bringing it to clinicians in the U.S. Ross said the company expects to launch the product in the beginning of next year.
Patients undergoing transcatheter aortic valve implant may need a pacemaker after the TAVR device, but a new study suggests that right bundle branch block may predict the need for pacing. The data may have implications for device selection as some devices are seen as less likely to trigger the need for a pacemaker, a development that may move the needle in the robust but increasingly competitive market for TAVR.
Dublin-based Medtronic plc is highlighting results from the MARVEL 2 study showing that an investigational set of algorithms in the Micra Transcatheter Pacing System (TPS) helps those with normal sinus node function and atrioventricular (AV) block.
Los Altos, Calif.-based Heartvista Inc. has received the U.S. FDA's nod for its One Click autonomous MRI acquisition software for cardiac exams. The company said that One Click is the first artificial intelligence (AI)-assisted solution designed specifically with the goal of enhancing the performance and results of cardiac MRI scans.
TORONTO – Winnipeg, Manitoba-based Medicure Inc. said results of a study released last week could nudge the door open wider in the U.S. for a device adapted from the military to normalize lung fluid content in patients suffering from heart failure.
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