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  • First-Ever De Novo Clearance by FDA’s Orthopedic Branch

    According to IlluminOss Medical, Inc.'s recent press release, the company has successfully obtained the first-ever de novo clearance from the FDA's Orthopedic Branch for its minimally invasive bone stabilizaion system (the "IlluminOss System").  According to the FDA, the de novo clearance is reserved for new, novel devices whose type has not been previously classified. IlluminOss, a privatel ...
  • Report Finds European Union’s Assessment of High-Risk Medical Devices of Low Quality

    A report appearing in the December 2017 issue of Value in Health, (a journal of the International Society for Pharmacoeconomics and Outcomes Research) concluded that assessments of high-risk medical devices in the European Union were of low quality - based on evidence from studies that were methodologically inadequate. The authors of the report reviewed 1,376 health technology assessment repor ...
  • Microbot Medical to Acquire CardioSert’s Technology

    Microbot Medical Inc. announced that it entered into an agreement with CardioSert Ltd. to acquire CardioSert's patented guidewire technology, including R&D information, technical know-how, and intellectual property. Microbot expects the acquisition to close in April 2018, at which time Microbot expects to have a patent portfolio of 25 issued/allowed patents and 15 pending patent applica ...
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