MedTech News
.................... by Andrew Celentano
FDA clears Spectrum Dynamics’ Veritas.AI platform
Veritas.AI is designed to advance the functionality of Spectrum Dynamics’ VERITON-CT scanner for nuclear imaging.
KORU Medical receives FDA clearance for FreedomEDGE infusion system
Rystiggo is administered weekly, 3ml to 6ml over 15 to 30 minutes for six weeks.
GRAIL Submits FDA Premarket Approval Application for the Galleri® Multi-Cancer Early Detection Test
MENLO PARK, Calif., Jan. 29, 2026 /PRNewswire/ — GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today announced the submission of the final module of the Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its Galleri® multi-cancer early detection (MCED) test. The FDA designated the test as a Breakthrough Device in 2018.
Zeus Launches PFX™ Platform and Introduces PFX Flex™ Sub-Lite-Wall™, Advancing the Future of Catheter Innovation
ORANGEBURG, S.C., Jan. 29, 2026 /PRNewswire/ — Zeus, a global leader in advanced polymer solutions, today announced the launch of PFX™, a breakthrough platform designed to advance catheter innovation with a focus on performance, design flexibility, and sustainability.
NEXTBIOMEDICAL Secures Health Canada Approval for Nexsphere-F™ in Musculoskeletal Pain Embolization
SEOUL, South Korea, Jan. 29, 2026 /PRNewswire/ — NEXTBIOMEDICAL CO., LTD. (KOSDAQ: 389650), an innovative medical device company based in South Korea, announced today that Nexsphere-F™, the company’s novel fast resorbable microsphere for musculoskeletal pain embolization has received approval from Health Canada.
FDA Qualifies MolecuLightDX Wound Measurement as a Medical Device Development Tool (MDDT) for Evaluating New Products in Wound Care
PITTSBURGH, Jan. 29, 2026 /PRNewswire/ — MolecuLight today announced that its MolecuLightDX® wound measurement has been qualified by the U.S. Food and Drug Administration (FDA) as a Medical Device Development Tool (MDDT). The FDA’s MDDT program qualifies select, scientifically validated tools for use in medical device development and evaluation, enabling sponsors to generate reliable, FDA accepted data in clinical investigations.
Spectrum Dynamics Medical Receives FDA 510(k) Clearance for Veritas.AI™, Its AI-Powered Noise Reduction Platform for VERITON-CT
SARASOTA, Fla., Jan. 29, 2026 /PRNewswire/ — Spectrum Dynamics Medical, a global leader in digital nuclear medicine imaging solutions, today announced that it has received FDA 510(k) clearance for Veritas.AI™ Noise Reduction, its advanced artificial intelligence platform designed to significantly enhance image quality, diagnostic confidence, and operational efficiency on the VERITON-CT® digital SPECT/CT system.
Nivalon Medical Produces the World’s First Fully Patient-Specific, Motion-Preserving, Metal-Free Spinal Implant Using AI and Advanced Ceramic 3D Printing
YOUNGSTOWN, Ohio, Jan. 29, 2026 /PRNewswire/ — Nivalon Medical Technologies Inc. has successfully produced the world’s first fully patient-specific, motion-preserving spinal implant built entirely without metal, using AI-driven design and advanced ceramic 3D printing.