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.

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.

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.

Nalu Medical announced today that the FDA cleared expanded labeling of its peripheral nerve system to include whole-body MRI use.

SUNNYVALE, Calif., Jan. 21, 2025 /PRNewswire/ — Inflammatix, a pioneering host response diagnostics company, today announced that the U.S. Food and Drug Administration (FDA) has granted marketing authorization for the TriVerity™ Test System (TriVerity), a first-in-class molecular test for patients with suspected acute infection or sepsis. Using precise measurements of a patient’s immune response, TriVerity combines highly accurate bacterial-viral infection scoring with an all-cause illness severity risk evaluation, giving clinicians a rapid and holistic snapshot of a patient’s status.