First TAVR Filter Gets US FDA Panel Date

Claret Medical’s Sentinel CPS missed its primary endpoint during a pivotal trial but showed greater benefits for patients receiving Sapien XT valves, and affirmed that it trapped debris and had a clinical benefit.

A device that is intended to cut the risk of embolism during transcatheter aortic valve replacement (TAVR) procedures – but showed uneven results in recent clinical trial data – will be up for discussion during the first US FDA device advisory panel meeting announced for 2017.

The Circulatory System Devices Panel plans to meet Feb. 23 in Gaithersburg, Md., to discuss the de novo application for...

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The Development Bank of Wales and London-based Parkwalk Advisors led an investment round of £5m, almost doubling Ceryx Medical's total investment to date.

SS Innovations’ SSI Mantra 3 Poised To Challenge Da Vinci In Robotic Surgery Market

 
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SS Innovations reported its first SSi Mantra 3 robotic cardiac surgery in South America as it prepares to file for US FDA de novo clearance and a CE mark. The firm aims to challenge Intuitive Surgical with a lower-cost, flexible system targeting US and European markets.

Innovative Wants Injunction Against J&J Subsidiary After $442M Antitrust Verdict

 
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Innovative Healthcare is asking for a permanent injunction against Johnson & Johnson subsidiary Biosense Webster after winning a $442 million antitrust verdict. The injunction aims to prevent continued anticompetitive practices in the electrophysiology catheter market.

Veterinary Heart Health Goes High-Tech: Eko And Boehringer Use AI To Spot Heart Murmurs In Dogs

 
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Eko hopes its new partnership with Boehringer Ingelheim to develop algorithms for accurately detecting heart murmurs in dogs will pave the way for more collaborations with medical and pharmaceutical companies to advance early detection in humans as well as animals.

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