ThinkSono has received US FDA 510(k) clearance for ThinkSono Guidance, AI-powered software designed to help non-ultrasound-trained healthcare professionals acquire vascular ultrasound images when evaluating adults with suspected deep vein thrombosis (DVT).

The company said the clearance makes ThinkSono Guidance the first AI-powered ultrasound guidance software cleared by the FDA for suspected DVT evaluation.

The technology provides real-time guidance during probe positioning and image acquisition for lower extremity compression ultrasound examinations. ThinkSono said it is designed to help address potential delays in DVT assessment where access to trained sonographers and vascular laboratories is limited, including overnight, at weekends and in rural or resource-constrained healthcare settings.

Venous thromboembolism, which includes DVT and pulmonary embolism, affects up to 900,000 people in the US each year, according to the US Centers for Disease Control and Prevention. The condition is potentially life-threatening but can be treated when identified promptly.

AI guides image acquisition rather than interpretation

ThinkSono Guidance connects to compatible FDA-cleared handheld point-of-care ultrasound scanners through a mobile app. Its AI algorithm guides the operator in real time through probe positioning and the recording of venous compression cine-loops at anatomical sites relevant to lower extremity DVT.

The resulting recordings are sent to the ThinkSono Guidance Dashboard, where a qualified remote clinician reviews image quality and assesses vein compressibility.

The software does not interpret ultrasound images or make a diagnosis. Instead, it is intended to help less experienced operators acquire images that can then be reviewed by a qualified clinician, with all clinical decisions remaining under the authority of that clinician.

In clinical studies, operators completed examinations following between 60 and 90 minutes of standardised training.

Fouad Al-Noor, CEO and co-founder of ThinkSono, said: “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.”

The approach could allow healthcare organisations to perform ultrasound image acquisition closer to the point of care while retaining specialist clinical review.

Multicentre studies support FDA clearance

The 510(k) clearance was supported by prospective, double-blinded, multicentre clinical investigations comparing examinations performed using ThinkSono Guidance by non-ultrasound-trained operators with reference-standard specialist duplex ultrasound.

The pivotal US study enrolled 594 patients across five sites. Across the wider programme, 1,691 patients were recruited at 24 US and international sites, including 157 patients with confirmed DVT.

In a pooled analysis, examinations achieved adequate diagnostic image quality in 87.1% of cases. Sensitivity was 92.9%, with prioritisation specificity of 97.1%.

The median operator scan time was five minutes and 24 seconds, while median remote review time was two minutes and 13 seconds.

ThinkSono said performance remained consistent across demographic subgroups, including age, sex, body mass index and race or ethnicity.

The company said these results support the use of the technology to help expand access to DVT assessment while reducing the need for a specialist sonographer to be physically present for the initial image acquisition.

ThinkSono prepares for US commercial launch

ThinkSono Guidance previously received FDA Breakthrough Device Designation in February 2026. The programme is intended for devices that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions.

Michael Blaivas, chief medical officer of ThinkSono, said: “By enabling a much wider range of healthcare professionals to capture these images, we can reach patients faster and reduce delays to lifesaving treatment.”

ThinkSono Guidance is available by prescription and operates with compatible FDA-cleared Clarius handheld point-of-care ultrasound scanners.

The company is now preparing for commercial availability in the US.

The FDA clearance adds to the growing use of artificial intelligence in medical imaging, with AI increasingly being developed not only to interpret scans but also to support the acquisition of consistent, clinically useful images.

For DVT assessment, ThinkSono’s approach focuses on the acquisition stage, potentially allowing more healthcare professionals to capture ultrasound examinations while remote qualified clinicians retain responsibility for image assessment and clinical decisions.