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A March FDA inspection revealed that Bellus Medical marketed and distributed its SkinPen device without approved premarket clearance or an investigational device exemption. Read More
Medicare spent $1.5 billion and patients spent $140 million as a result of just seven recalled or failed cardiac devices, spending that could be better controlled if unique device identifiers (UDIs) were required on CMS claim forms, according to a report by the HHS Office of Inspector General (OIG). Read More