SKIA HEAD: AR Surgical Guidance Receives FDA 510(k) Clearance, Eyes U.S. Expansion with Structure Partnership
SEOUL, South Korea, May 29, 2026 /PRNewswire/ -- South Korea-based medtech innovator SKIA has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its augmented reality (AR) surgical guidance system, SKIA HEAD....
3Shape Receives FDA 510(k) Clearance for 3Shape Dx Software
COPENHAGEN, Denmark, April 28, 2026 /PRNewswire/ -- 3Shape today announced that the U.S. Food and Drug Administration (FDA) has granted FDA clearance for its Dx Software following a review completed on April 10. 2026. The 510(k) Premarket...
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...
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 –...