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...
6Letters Launches "MOJO KING," an Apple Watch-Based iOS App for Non-Invasive Testosterone Monitoring
SEOUL, South Korea, Jan. 19, 2026 /PRNewswire/ -- Digital healthcare startup 6Letters today announced the official launch of MOJO KING, an iOS application that enables non-invasive monitoring of testosterone-related physiological patterns using...
Terumo Interventional Systems Announces Its New OPUSWAVE® Dual Sensor Imaging System and DualView® Imaging Catheter Receive FDA 510(k) Clearance
OPUSWAVE Imaging System combines OFDI and IVUS into a single catheter, providing significant potential to reduce procedural time and costs in treating coronary artery disease DualView imaging catheter offers a 150mm maximum pullback length, a 2.6...
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 –...