Envoy Medical Submits First Module of FDA PMA Application for Breakthrough Hearing Implant
WHITE BEAR LAKE, Minnesota, June 30, 2026 Envoy Medical announced the submission of the first module of its Modular...
breakthrough device
Advertisement
GlycoNex Reports Positive Phase III Results for SPD8 Biosimilar
NEW TAIPEI CITY, Taiwan, June 11, 2026 GlycoNex, Inc. (GNX) announced positive topline results from its Phase III clinical...
Wave Neuroscience Wins FDA Clearance for MeRT in PTSD
NEWPORT BEACH, Calif., June 11, 2026 Wave Neuroscience announced that the U.S. Food and Drug Administration (FDA) has granted...
FDA Grants Breakthrough Status to AMR Rapid Tests
Innovative Diagnostics Target Critical Drug Resistance February 18, 2026 | Santa Maria, California U.S. Food and Drug Administration has...
Acclaim Cochlear Implant Trial Nears Full Enrollment
WHITE BEAR LAKE, MINNESOTA, UNITED STATES — February 17, 2026 Envoy Medical announced that enrollment in its pivotal clinical...
Advertisements
CSA Medical Submits PMA for RejuvenAir After Pivotal Trial Success
BOSTON | January 7, 2026 — CSA Medical, a U.S.-based medical device company focused on interventional pulmonary therapies, has...
Gore Wins FDA Approval for First IVC Deep Venous Stent
FLAGSTAFF, Arizona | January 6, 2026 — W. L. Gore & Associates has secured U.S. FDA approval for the...
FDA Approves U.S. Trial for EndoArt Synthetic Corneal Implant
NES ZIONA, Israel, December 8, 2025 — EyeYon Medical Ltd. announced that the U.S. Food and Drug Administration (FDA)...
NEXTBIOMEDICAL Launches U.S. Pivotal Trial for Nexsphere-F™ in Knee OA
SEOUL, South Korea, Oct. 13, 2025 — NEXTBIOMEDICAL CO., LTD. (KOSDAQ: 389650), a South Korea-based innovative medical device company,...
Precision Robotic CERTA Access System Records First U.S. Clinical Outcomes
Fort Lauderdale, FL – September 4, 2025 – The first U.S. clinical cases using the CERTA™ Access System, a...
Advertisement
