FDA clears AI 3D head, neck imaging tech from RapidAI
February 4, 2025
RapidAI announced that it received FDA 510(k) clearance for its Lumina 3D automated 3D imaging reconstruction solution.
RapidAI announced that it received FDA 510(k) clearance for its Lumina 3D automated 3D imaging reconstruction solution.
INDIANAPOLIS, Jan. 29, 2025 /PRNewswire/ — Roche announced today that the Tina-quant® Lipoprotein (a) Gen.2 Molarity assay has received 510(k) clearance from the United States Food and Drug Administration (FDA). This will be the first 510(k) cleared test of its kind available in the U.S. measuring lipoprotein (a), or Lp(a), in nanomoles per liter (nmol/L). The National Lipid Association (NLA) recommends all adults measure their Lp(a) – often referred to as L-P-Little-A – at least once in a lifetime to help assess cardiovascular risk.
RICHMOND, Va. and ATLANTA, Jan. 29, 2025 /PRNewswire/ — OrthoPreserve, a company developing orthopedic implant solutions, announced today it has been granted both a Breakthrough Device Designation and Total Product Life Cycle Advisory Program (TAP) enrollment from the U.S. Food & Drug Administration (FDA) for Defender, a meniscus replacement implant.
NEW YORK, Jan. 28, 2025 /PRNewswire/ — AI Optics Inc., an AI-focused medical device company announced today that it has received FDA 510(k) clearance for its Sentinel Camera. This handheld retinal imaging system captures high-quality images of the human eye, helping to address critical gaps in retinal disease screening through a portable and accessible solution.
BREA, Calif., Jan. 28, 2025 /PRNewswire/ — Beckman Coulter Diagnostics, a global leader in clinical diagnostics, today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Beckman Coulter’s Access p‑Tau217/β-Amyloid 1-42 plasma ratio. This blood test is designed to aid healthcare providers identify patients with amyloid pathology associated with Alzheimer’s disease.
Instylla today said it has won FDA 510(k) clearance for its Tembo Embolic System.
BALLERUP, Denmark and REDWOOD CITY, Calif., Jan. 27, 2025 /PRNewswire/ — Norlase, a leading global ophthalmic laser manufacturer developing next-generation laser solutions, today announced the immediate commercial launch and FDA 510(k) clearance and CE Mark for Norlase® LYNX™, the world’s first and only pattern scanning laser indirect ophthalmoscope.
Imperative Care announced today that it has secured FDA 510(k) clearance for its Zoom comprehensive stroke thrombectomy system.
Stereotaxis (NYSE:STXS) said today that it has secured CE mark approval for its Magic robotically-navigated magnetic ablation catheter.
MINNEAPOLIS, Jan. 23, 2025 /PRNewswire/ — Saluda Medical, Inc., a pioneer in the development and commercialization of a novel neuromodulation platform designed to transform the lives of patients with chronic neurological conditions, today announced United States (U.S.) Food & Drug Administration (FDA) approval for its biomarker-based, automated patient programming platform in spinal cord stimulation (SCS), representing a significant advancement for SCS therapy.