FDA clears ThinkSono's AI ultrasound guidance software for DVT screening
ThinkSono received FDA 510(k) clearance (K260338) for ThinkSono Guidance, AI software that walks non-ultrasound-trained staff through acquiring leg-vein compression ultrasound images to evaluate suspected deep vein thrombosis. The software pairs with Clarius handheld point-of-care ultrasound scanners and, after 60-90 minutes of operator training, guides probe positioning and recording; a remote qualified clinician then grades image quality and makes the diagnostic call. In a double-blinded trial across 24 sites with 1,691 patients, exams reached adequate diagnostic image quality in 87.1% of cases, with 92.9% sensitivity and 97.1% specificity for DVT. The FDA had granted the software Breakthrough Device designation earlier in 2026.
Why it's notable: It lets a bedside nurse or clinician without ultrasound training capture DVT scans that a remote specialist can review within minutes, a way to get a common, dangerous, treatable condition diagnosed faster at sites that lack a trained ultrasonographer.