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Speedboat RS2 Endoscopic Device Receives FDA Clearance

UK-based Creo Medical recently announced the clearance of its Speedboat RS2 surgical endoscopic device for minimally invasive removal of lesions in the bowel....more

FDA Announces International Draft Guidance for Clinical Evaluation of Software as a Medical Device

The U.S. Food and Drug Administration announced the availability of a draft guidance for the clinical evaluation of software as a medical device (SaMD). The draft guidance was prepared by the SaMD Working Group of the...more

FDA Proposes Ban on Electrical Stimulation Devices for Aggressive or Self-Injurious Behavior

On April 25, the U.S. Food and Drug Administration published a proposed rule banning electrical stimulation devices (ESDs) used to treat aggressive or self-injurious behavior....more

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