Regulatory Approvals

Medtronic plc obtained the CE mark for its Sensight directional lead system for deep brain stimulation (DBS) for movement disorders and epilepsy, which is designed...

LimFlow SA, a pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery...

Boston Scientific has received U.S. Food and Drug Administration (FDA) approval of the TheraSphere Y-90 Glass Microspheres, developed for the treatment of patients with hepatocellular carcinoma...

Life Spine, a leading medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that...

Check-Cap Ltd., a clinical stage medical diagnostics company advancing the development of C-Scan® , the first and only patient-friendly, preparation-free, screening test to detect polyps...

Two-incision approach reduces average procedure time by approximately 20 percent MINNEAPOLIS, Minnesota – March 15, 2021 – Inspire Medical Systems, Inc. (NYSE: INSP) (“Inspire”), a...

Eitan Medical announced that it received European Union Medical Device Recognition (MDR) certification for its Sapphire infusion pump. Approval for the Sapphire infusion pump, along with...

Ready for commercial distribution, the first single-sided MRI, cleared for office setting, will be available in the United States. The United States Food and Drug...

The system delivers its results to a companion app in about 20 minutes, according to the agency. The FDA has issued its first emergency use...