Amplitude Vascular Systems announced today that it received FDA investigational device exemption (IDE) for its pulsatile intravascular lithotripsy (PIVL) therapy.
Abbott (NYSE: ABT)+ announced today that it received CE mark approval for its Aveir dual-chamber (DR) leadless pacemaker system.
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)
FloPatch from Flosonics Medical provides real-time patient data to enhance clinical decision-making during life-saving critical care events
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 announced today that it received FDA clearance for the commercial version of its Maestro surgical robot system.
Watmind USA announced that the FDA granted it emergency use authorization (EUA) for its SpeedySwab COVID + flu A&B self test.
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.
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 ONE is approved for EEG Brain Monitoring across hospital, home, ambulance, and air transport environments.