ThinkSono has received FDA 510(k) clearance for ThinkSono Guidance, becoming the first AI-powered ultrasound guidance software cleared in the United States to assist in the evaluation of suspected lower-extremity deep vein thrombosis (DVT). The software is designed to help healthcare professionals without formal ultrasound training acquire clinical-grade vascular ultrasound images using compatible Clarius handheld point-of-care ultrasound (POCUS) devices, while leaving all diagnostic decisions to qualified clinicians.
The clearance follows the software’s FDA Breakthrough Device Designation earlier in 2026 and supports a workflow that separates image acquisition from clinical interpretation. Through a mobile application, the platform provides real-time computer vision guidance, directing users on probe positioning, pressure application, and anatomical alignment while scanning the proximal deep venous system. Once standardized venous compression cine-loops have been captured, the recordings are automatically transferred to the ThinkSono Guidance Dashboard, where radiologists or vascular specialists can remotely assess image quality and evaluate vein compressibility.
Clinical evidence supporting the clearance comes from a double-blinded multicenter study involving 1,691 patients across 24 sites in the United States and internationally. In the study, non-expert operators produced diagnostic-quality images in 87.1% of examinations, while the system demonstrated 92.9% sensitivity and 97.1% specificity. The workflow also reduced the median scan time to 5 minutes and 24 seconds, with remote review completed in a median of 2 minutes and 13 seconds.
Importantly, ThinkSono Guidance functions solely as an image acquisition tool and does not provide diagnostic interpretation or AI-generated clinical conclusions. Diagnostic responsibility remains entirely with qualified physicians reviewing the transmitted images.
Commenting on the milestone, Fouad Al-Noor, CEO and Co-Founder of ThinkSono, said, “DVT is common, dangerous, and treatable, yet whether a patient gets scanned quickly still depends on where and when they happen to present. This clearance means a nurse or clinician at the bedside, guided by our software, can capture the images a specialist needs, and a qualified clinician can review them remotely within minutes.”
As ThinkSono begins its U.S. commercial rollout alongside handheld ultrasound partner Clarius, the company aims to expand access to timely vascular imaging across emergency, acute, and outpatient care settings through connected point-of-care ultrasound workflows.
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