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GRAIL Submits FDA Premarket Approval Application for the Galleri® Multi-Cancer Early Detection Test

January 29, 2026

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.

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FDA Qualifies MolecuLightDX Wound Measurement as a Medical Device Development Tool (MDDT) for Evaluating New Products in Wound Care

January 29, 2026

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.

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Spectrum Dynamics Medical Receives FDA 510(k) Clearance for Veritas.AI™, Its AI-Powered Noise Reduction Platform for VERITON-CT

January 29, 2026

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.

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