LimFlow Receives Japan PMDA Approval for Clinical Study of Minimally-Invasive Technology Designed to Prevent Amputations in Chronic Limb-Threatening Ischemia Patients
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 receives FDA approval for TheraSphere device
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 Announces FDA 510(k) Clearance for the PROLIFT® Wedge Expandable Spacer System
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 Receives FDA IDE Approval for Pivotal Study of C-Scan®
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...
Inspire Medical Systems, Inc. Announces FDA Approval of Two-Incision Implant Procedure
Two-incision approach reduces average procedure time by approximately 20 percentMINNEAPOLIS, Minnesota – March 15, 2021 – Inspire Medical Systems, Inc. (NYSE: INSP) (“Inspire”), a...
Eitan Medical wins EU clearance for Sapphire infusion pump
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...
Promaxo Receives 510(k) Clearance from the FDA for its Innovational MRI Platform
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...
FDA gives Cue Health first EUA for at-home, OTC COVID-19 molecular testing
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...
Relivion® Wearable Brain Neuromodulation Technology Cleared by FDA for the Treatment of Migraine
Neurolief, an innovator in neurotechnology, announces the company has received Food and Drug Administration (FDA) clearance for its Relivion® system. Relivion® is the first non-invasive...