Israel-based BrainsWay recently announced the de novo FDA clearance of its Deep Transcranial Magnetic Stimulation (TMS) system for treatment of obsessive compulsive disorder (OCD)....more
The Food and Drug Administration (FDA) has announced a medical device innovation challenge to help address opioid abuse and misuse. With the FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder, the FDA...more
Tel Aviv-based MedyMatch Technology recently announced it has received Expedited Access Pathway (EAP) designation from the FDA for its intracranial hemorrahage (ICH) detection software medical device....more
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
Novocure recently announced final results from a phase III EF-14 clinical trial of its Optune device for treatment of newly diagnosed glioblastoma (GBM)....more
The U.S. Food and Drug Administration announced the availability of a draft guidance for the clinical evaluation of software as a medical device (SaMD). The draft guidance was prepared by the SaMD Working Group of the...more
Second Sight announced in a press release the publication of positive results from a long-term clinical trial of the Argus II Retinal Prosthesis System. According to the press release, the five-year trial included 30...more
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
According to its recent press release, Stryker Corporation has reached an agreement to acquire Sage Products, LLC from Chicago private equity firm Madison Dearborn Partners in a $2.775 billion cash transaction. Stryker...more