Exactech Inc., of Gainesville, Fla., decided it will not subject itself to a 10-year corporate integrity agreement with the Office of Inspector General, an understandable move given that the company no longer intends to do business in the U.S. under its old brand.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Apple, Brainsway, Caranx, Cardiovalve, GE Healthcare, GTCR, ITM, Labcorp, Lunit, Masimo, Naveris, Positron, Surmodics, Venus Medtech.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Onward Medical.
Withings SA received U.S. FDA clearance for Beamo, its health check-up tool designed to monitor heart and lung function. Described as the ‘thermometer of the future’, Beamo combines the sensors of an electrocardiogram, a stethoscope and a thermometer into a hand-held device to allow users to check their body temperature, cardiac and pulmonary health in less than a minute.
Cornerstone Robotics Ltd. raised an oversubscribed $200 million series D round to accelerate commercialization of its flagship product, the Sentire Endoscopic Surgical System.
The U.S. Environmental Protection Agency has moved to relax reporting requirements for perfluoroalkyl and polyfluoroalkyl substances used in a variety of applications, including medical devices.
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