Firm files PMA for its automated, qualitative hepatitis B diagnostic, which detects antibodies to the hepatitis B virus core antigen. The test is run on the firm's Architect laboratory immunoassay analyzer. Abbott cites CDC statistics indicating that 1.25 million people in the U.S. have chronic hepatitis B
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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 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 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.
