The agency is sounding the alarm after receiving more than 450 adverse event reports in four years tying patient infections to the devices. Products from Olympus and Karl Storz were cited in the reports.
FDA has now categorized 13 HeartWare products recalled as Class I events in the past 13 months amid a stream of fault reports that have been implicated in the deaths.
Cancer tests feature heavily in the latest round of agency breakthrough designations, with Natera, Inivata and Bluestar Genomics all securing the status.
The court ruled the case can go forward on the question of whether the medtech defrauded the agency to gain 510(k) clearance for several products by failing to disclose the devices were intended for use in cervical spine.
The medtech lobby and 39 stakeholders warned CMS that including cervical fusion with disc removal and implanted spinal neurostimulators as new service categories will delay patient access to medically necessary procedures.
Medtronic and Globus Medical are currently in a "two pony race" in the space, Wall Street analysts say, but market share can be stolen as other companies launch systems and adoption grows.
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