FDA clears RevealDX’s AI lung nodule diagnostic
February 3, 2026
RevealDX’s software analyses CT scans and assigns lung nodules with a Malignancy Similarity Index score to aid in lung cancer diagnosis.
RevealDX’s software analyses CT scans and assigns lung nodules with a Malignancy Similarity Index score to aid in lung cancer diagnosis.
Johnson & Johnson MedTech (NYSE: JNJ)+
today announced the full commercial release of its NuVision Nav ultrasound catheter.
The Mosaic 3D device incorporates several features designed to enhance safety and patient comfort.
GE HealthCare (Nasdaq: GEHC)+
announced today that it received FDA 510(k) clearance and CE mark for its Allia Moveo platform.
Medtronic (NYSE: MDT)+
today announced three U.S. milestones expanding access to its MiniMed 780G automated insulin delivery system.
Veritas.AI is designed to advance the functionality of Spectrum Dynamics’ VERITON-CT scanner for nuclear imaging.
Rystiggo is administered weekly, 3ml to 6ml over 15 to 30 minutes for six weeks.
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.
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.
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.