Paragonix Technologies said today that the FDA granted 510(k) clearance for a design change to its SherpaPak heart transport device so that it can be used with small and pediatric hearts. Braintree, Mass.-based Paragonix said it will begin shipping heart connectors covering most aortic diameters during the first quarter of 2019. “This FDA clearance is an […]
Colombia clears Hancock Jaffe first-in-human VenoValve trial
Hancock Jaffe Laboratories (NSDQ:HJLI) said today that it won regulatory approval from Colombia’s INVIMA, the country’s FDA equivalent, to launch a first-in-human trial of its VenoValve device. The VenoValve is a porcine valve designed to be implanted into the femoral or popliteal vein to treat lower limb chronic venous insufficiency from damage to leg vein valves after […]
Acute decompensated HF treatment device dev WhiteSwell raises $30m in Series B
Early stage device developer WhiteSwell said this week it closed a $30 million Series B round of financing to help support continued development and a pivotal study of the company’s technology intended to treat acute decompensated heart failure. The round was led by RA Capital Management and an InCube Ventures syndicate and joined by other […]
Boston Scientific touts win in continued TAVR patent spat with Edwards Lifesciences
Boston Scientific (NYSE:BSX) today claimed a win in an ongoing patent spat with Edwards Lifesciences (NYSE:EW) over transcatheter aortic valve replacement system patents. Marlborough, Mass.-based Boston Scientific said that a jury in the U.S. District Court for the District of Delaware ruled in its favor, finding that their ‘608 patent, related to a transcatheter heart valve sealing skirt, […]
BioCardia submits bid for FDA clearance of Avance transseptal introducer
BioCardia (NSDQ:BCDA) said today that it submitted an application for FDA 510(k) clearance for its Avance steerable introducer intended for introducing cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. The San Carlos, Calif.-based company said the Avance device uses new technology developed for the company’s Morph line of […]
Abiomed puts $15m into Shockwave
Abiomed (NSDQ:ABMD) plans to invest $15 million in Shockwave Medical and collaborate on a training and education program in the U.S. and Germany, according to a newly-inked deal between the two companies. Shockwave’s intravascular lithotripsy technology uses sonic pressure waves to crack vascular calcium in the vessel wall, allowing arteries to expand under low pressure. The […]
Edwards Lifesciences, Bay Labs ink cardio-focused collab AI-dev deal
Edwards Lifesciences’ (NYSE:EW) and cardiovascular artificial intelligence medtech firm Bay Labs, have inked a multi-faceted collaborative cardiovascular-focused development deal, Bay Labs said today. San Francisco-based Bay Labs said that the partnership involves multiple initiatives including the development of new AI-powered algorithms in Bay Labs’ EchoMD software suite and the integration of EchoMD algorithms into Edwards’ CardioCare […]
Meril Life Sciences wins approval for TAVR in India
Indian medtech maker Meril Life Sciences has won regulatory approval for a transcatheter aortic valve replacement (TAVR) developed exclusively in India, according to a published report. The MyVal device is balloon-expandable and employs a hybrid honeycomb cell design. The upper, open cells were designed to ensure un-jailing of coronary ostia, and the closed, lower cells […]
How Reggie Groves reinvented Medtronic’s atrial fibrillation biz
Reva Medical (ASX:RVA) CEO Reggie Groves got her start in the medical device industry at medtech titan Medtronic. In her upcoming keynote interview at DeviceTalks West, Groves will discuss how that experience has shaped her as a leader and an innovator. Here’s a preview: When Reggie Groves joined Medtronic (NYSE:MDT) in 2002, she didn’t know very much […]
Corindus touts first-in-human coronary telerobotics study with CorPath system
Corindus Vascular Robotics (OTC:CVRS) today touted that its CorPath robotic surgical platform was used in a first-in-human telerobotic intervention study in India. The Waltham, Mass.-based company touted that the study was the world’s first percutaneous coronary intervention conducted from a remote location outside of a catheterization lab. In the trial, five patients at India’s Apex Heart […]
FDA panel votes in support of Impulse Dynamic’s cardiac contractility modulation pulse generator
The FDA’s Circulatory Systems Device Panel this week voted in favor of Impulse Dynamics’s Optimizer Smart implantable pulse generator, supporting the company’s premarket approval application seeking clearance for use in patients suffering from heart failure, according to a Healio report. The Optimizer impulse generator is designed to remodel the myocardium to increase the heart’s efficiency […]
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