MedTech News
.................... by Andrew Celentano
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.
Abbott wins FDA clearance for its Lingo OTC glucose monitor
Abbott (NYSE: ABT)+ has secured a 510(k) clearance from the FDA for its over-the-counter Lingo glucose-monitoring biowearable.
Enable Biosciences Secures Patent for Antibody Detection Method with Applications in Type 1 Diabetes
SOUTH SAN FRANCISCO, Calif., May 30, 2024 /PRNewswire/ — Enable Biosciences Inc. has been awarded a patent for a cutting-edge method of detecting polyclonal antibodies, marking a significant advancement in diagnostic technologies, particularly in assessing the risk of Type 1 Diabetes (T1D).
TOOsonix receives MDR CE Mark for its new oncology and dermatology device
The EU Medical Device Regulation CE certification approves that the most common types of skin cancer and a wide range of skin diseases and conditions can be treated in less than 90 seconds.