MedTech News
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.
Evolution Optiks Receives U.S. FDA 510(k) Clearance for Breakthrough Eye Examination Device
CHRIST CHURCH, Barbados, June 4, 2024 /PRNewswire/ — Evolution Optiks Limited, a privately held company specializing in light field technology, today announced the receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the LFR-260, the world’s first light field powered subjective tele-refractor. This is the second regulatory clearance for the device after obtaining the European CE mark in March 2024.
Zeto obtains FDA 510(k) clearance for its groundbreaking next-generation EEG brain monitoring product, ONE.
Zeto ONE is approved for EEG Brain Monitoring across hospital, home, ambulance, and air transport environments.
FDA approves Microbot Medical endovascular surgical robot trial
Microbot Medical (Nasdaq:MBOT) this week announced it received FDA approval to start its human clinical trial for its Liberty Endovascular Robotic Surgical System.