Phantom Neuro today announced it received FDA breakthrough device designation and Targeted Acceleration Pathway (TAP) designation for its minimally invasive neural interface Phantom X.
MINNEAPOLIS and MISGAV, Israel, Feb. 27, 2025 /PRNewswire/ — Arcuro Medical Ltd., (“Arcuro”) today announced that it received FDA 510(k) clearance for its new SuperBall-RC™ system for use in rotator cuff repair procedures.
SAN JOSE, Calif., Feb. 26, 2025 /PRNewswire/ — Visby Medical™ announced today that it has received 510(k) clearance and was granted a CLIA waiver from the U.S. Food and Drug Administration (FDA) for its point-of-care respiratory health test. The Visby Medical Respiratory Health Test is a rapid polymerase chain reaction (PCR) test that detects and differentiates between upper respiratory infections caused by influenza (Flu) A & B, and SARS-CoV-2 (COVID-19). This multiplexed molecular device is the first handheld test to receive this designation after being granted Emergency Use Authorization (EUA) in December 2022.
TULSA, Okla., Feb. 26, 2025 /PRNewswire/ — Sway Medical, Inc., the company that created the Mobile Concussion Management category, is proud to announce that it has received FDA 510(k) clearance as a Computerized Cognitive Assessment Aid for Concussion under Section 882.1471. This clearance expands on Sway Medical’s previous FDA clearance for balance testing in head injuries, officially recognizing Sway as the first fully integrated tool that combines both cognitive and balance testing into one product for concussion management.
PALM COAST, Fla., Feb. 25, 2025 /PRNewswire/ — OrthoNovis, Inc is proud to announce that it has received U.S. Food and Drug Administration (FDA) clearance to market its innovative BPS Wrist Fracture System. www.orthonovis.com
SAN FRANCISCO, Feb. 25, 2025 /PRNewswire/ — Averto Medical, a clinical-stage medical device company pioneering minimally invasive gastrointestinal care, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its ColoSeal™ Intraluminal Colonic Diversion (ICD) System. This designation underscores the potential of ColoSeal™ to significantly improve outcomes for patients undergoing colorectal surgery by eliminating the need for a temporary ostomy.
Tandem Diabetes Care (Nasdaq:TNDM) today announced a major regulatory win that brings its diabetes technology to more patients.
SANTA BARBARA, Calif., Feb. 24, 2025 /PRNewswire/ — Aptitude Medical Systems, Inc. (Aptitude) today announced it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its next-gen molecular Metrix® COVID/Flu multiplex test. This innovative test represents a major advancement in accessible molecular diagnostics.
Medtronic (NYSE: MDT)+
announced today that the FDA approved its BrainSense adaptive deep brain stimulation (aDBS) platform.
DUBLIN, Ohio, Feb. 20, 2025 /PRNewswire/ — Atreon Orthopedics, LLC, a Columbus based innovator in tissue healing and regenerative technologies, announces the 510(k) clearance from the Food and Drug Administration (FDA) and the full market launch of BioCharge® Autobiologic Matrix, a bioresorbable synthetic implant designed to address biological failure modes in rotator cuff repair while improving repair integrity and long-term patient outcomes.