CGBIO Receives FDA 510(k) Clearance for Patient-Specific Titanium Implant 'EASYMADE TI'
Patient-specific titanium implant designed for cranial and craniofacial reconstruction First Korean company to obtain FDA 510(k) clearance for a customized titanium implant in the U.S. market SEOUL, South Korea, April 24, 2026 /PRNewswire/ -- CGBIO...
FDA 510(k) Clearance Establishes Broad Intended Use for Copan's PhenoMATRIX®, Expanding Clinical Microbiology Capabilities
MURRIETA, Calif., Feb. 17, 2026 /PRNewswire/ -- Copan Group announced today that PhenoMATRIX®, its automated image assessment software used with WASPLab® full laboratory automation, received FDA 510(k) clearance as a Class II device in the United...
Brain Navi achieves U.S. FDA approval for neurosurgical robot NaoTrac
ZHUBEI CITY, June 17, 2025 /PRNewswire/ -- Brain Navi Biotechnology, a medical robotics company founded in 2015 in Taiwan by surgeon and serial entrepreneur Jerry Chen, has reached another major milestone. Following previous approvals from the...
DOSIsoft PLANET® Onco Dose receives CE MDR Mark and new FDA 510(k) clearance
PARIS, April 7, 2025 /PRNewswire/ -- DOSIsoft, leading provider of patient-specific imaging and dosimetry software solutions for radiation oncology and nuclear medicine, proudly announces the latest release of PLANET® Onco Dose version 3.2 –...