BOSTON and SHANGHAI, Sept. 3, 2024 /PRNewswire/ — Skyline Therapeutics, an innovation-driven gene therapy company committed to developing unique and novel solutions for rare and severe diseases, announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for SKG1108, a novel one-time intravitreally delivered gene therapy for the treatment of Retinitis Pigmentosa (RP).

BELFAST, Northern Ireland, Sept. 3, 2024 /PRNewswire/ — B-Secur, a leader in advanced biosensing technology, proudly announces the FDA clearance and launch of HeartKey® Rhythm, a suite of electrocardiogram (ECG) algorithms and analytics designed to enhance clinical confidence, streamline industry efficiency, and improve outcomes for cardiac patients.

ENGLEWOOD, Colo., Sept. 3, 2024 /PRNewswire/ — Zynex Inc. (NASDAQ: ZYXI), a leading medical technology company specializing in non-invasive medical devices for pain management and rehabilitation, today announced FDA clearance of its new TensWave device

SUNNYVALE, Calif., Sept. 3, 2024 /PRNewswire/ — VELMENI announced today it received FDA 510(k) clearance for VELMENI for DENTISTS, an innovative AI that analyzes and annotates dental X-Rays