Medical Device User Fee Negotiations: Here We Go Again

FDA is holding a meeting Sept. 14 to start a public dialogue on the next reauthorization of medical device user fees, more than two years before Congress needs to renew the program

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Ceryx Medical Amasses £11M To Develop Adaptive Cardiac Pacing Technology

 

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.