The company’s software helps healthcare professionals capture ultrasound images for suspected blood clots, potentially making assessments more accessible and reducing delays in care
London, 15 October 2026 – Getting a timely assessment for a suspected blood clot can be challenging when specialised ultrasound services are not immediately available. For patients experiencing symptoms of deep vein thrombosis, or DVT, delays can create uncertainty and slow the next steps in treatment. ThinkSono, a medical technology company focused on artificial intelligence, is working to address this challenge with software designed to guide healthcare professionals through ultrasound image collection.
The company has received clearance from the U.S. Food and Drug Administration (FDA) for ThinkSono Guidance, an AI-powered software that helps healthcare professionals without formal ultrasound training capture vascular ultrasound images. The technology is intended for adults undergoing lower limb compression ultrasound examinations to evaluate suspected DVT. The clearance marks an important step in bringing AI-assisted medical imaging into more healthcare settings.
DVT occurs when a blood clot forms in a deep vein, usually in the leg. If part of the clot travels to the lungs, it can cause a potentially life-threatening condition known as pulmonary embolism. Ultrasound is commonly used to assess suspected DVT, but the process often depends on trained specialists and access to suitable imaging facilities. These resources may not always be readily available, particularly in smaller hospitals, emergency departments, and remote locations.
ThinkSono Guidance is designed to help bridge this gap. The software works with compatible handheld ultrasound scanners and provides real-time instructions on probe positioning and image capture. It guides the operator through the scanning process so that the relevant veins are recorded for assessment. The images can then be uploaded to a dashboard for review by a qualified clinician.
Importantly, the software does not independently interpret the ultrasound images or make a diagnosis. A qualified healthcare professional remains responsible for reviewing the images and making clinical decisions. This distinction allows the technology to support image acquisition without replacing medical expertise.
The FDA clearance was supported by clinical investigations involving 1,691 patients across 24 sites in the United States and other countries. Reported study findings showed that the examinations produced adequate diagnostic image quality in 87.1 percent of cases. The pooled analysis also reported 92.9 percent sensitivity and 97.1 percent prioritisation specificity. These results support further evaluation of the technology, although performance in practice depends on the clinical setting and appropriate use.
The potential benefit extends beyond the technology itself. If healthcare teams can collect suitable ultrasound images closer to the patient, they may be able to reduce dependence on immediate access to specialised imaging departments. Remote review could also help connect frontline healthcare professionals with experienced clinicians, supporting more flexible assessment pathways.
ThinkSono Guidance is available by prescription and requires compatible, FDA-cleared handheld ultrasound equipment. The company is preparing for commercial availability in the United States.
As healthcare providers explore artificial intelligence in medical imaging, technologies such as ThinkSono Guidance demonstrate how AI can support specific clinical tasks. Its value will ultimately depend on safe implementation, clinician oversight, and evidence that it improves access to timely assessment for patients who may have a blood clot.