MedTech News
Amplitude Vascular Systems wins FDA IDE approval for intravascular lithotripsy study
Amplitude Vascular Systems announced today that it received FDA investigational device exemption (IDE) for its pulsatile intravascular lithotripsy (PIVL) therapy.
Abbott wins CE mark for dual-chamber leadless pacemaker
Abbott (NYSE: ABT)+ announced today that it received CE mark approval for its Aveir dual-chamber (DR) leadless pacemaker system.
Enspectra Health Receives FDA Breakthrough Device Designation for AI-powered Imaging Platform Targeting Skin Cancer
Enspectra Health, a health tech company, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its next generation AI-powered VIO™ Skin Platform (VIO)
World’s First Wearable Ultrasound Patch in use for sepsis care at a Toronto Hospital
FloPatch from Flosonics Medical provides real-time patient data to enhance clinical decision-making during life-saving critical care events
Lumenis introduces FoLix™, the first FDA-cleared proprietary fractional laser for hair loss treatment
YOKNE’AM ILLIT, Israel, June 5, 2024 /PRNewswire/ — Lumenis Be. Ltd., a leading energy-based medical device company for aesthetic and eye care solutions, is proud to announce the launch of its breakthrough laser system designed to combat hair loss. Recently cleared by the Food and Drug Administration (FDA), FoLix becomes the first and only fractional laser choice for safe, effective, and natural hair loss treatment for women and men in the United States.
Moon Surgical wins FDA clearance for commercial version of Maestro surgical robot
Moon Surgical announced today that it received FDA clearance for the commercial version of its Maestro surgical robot system.
FDA authorizes Watmind USA’s OTC COVID and flu test
Watmind USA announced that the FDA granted it emergency use authorization (EUA) for its SpeedySwab COVID + flu A&B self test.
FDA Clearance For Gastrointestinal Parasite Detection Kit
MELBOURNE, Australia, June 4, 2024 /PRNewswire/ — Genetic Signatures Limited [ASX:GSS] (“GSS” or the “Company”), a global molecular diagnostics company announces that the US Food & Drug Administration (“FDA”) has cleared the Company’s EasyScreen™ Gastrointestinal Parasite Detection Kit and GS1 automated workflow[1] for marketing and sale in the US.