What You Should KnowMedical AI developer ThinkSono has secured FDA 510(k) clearance for ThinkSono Guidance, the first AI-powered ultrasound guidance software cleared in the U.S. for evaluating suspected lower-extremity deep vein thrombosis (DVT). In a 1,691-patient double-blinded multicenter study across 24 international and U.S. sites, non-expert operators achieved adequate diagnostic image quality in 87.1% of cases with 92.9% sensitivity and 97.1% specificity. Standardized Cine-Loop Recording: Automated triggers capture standardized venous compression cine-loops, ensuring consistent, audit-ready imaging of critical anatomical sites. Asynchronous Dashboard Transmission: Recorded cine-loops automatically sync to the ThinkSono Guidance Dashboard, allowing off-site radiologists or vascular specialists to evaluate image quality and confirm vein compressibility within minutes. Recorded cine-loops automatically sync to the ThinkSono Guidance Dashboard, allowing off-site radiologists or vascular specialists to evaluate image quality and confirm vein compressibility within minutes.