FDA approves AI tool for stroke prediction

See-Mode Technologies, a medtech start-up based in Singapore and Australia that seeks to empower clinicians to better predict stroke, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its debut product, Augmented Vascular Analysis (AVA).

The product features artificial intelligence (AI) software for automated analysis and reporting of vascular ultrasound scans.

AVA uses deep learning, text recognition, and signal processing to assist clinicians in interpreting and reporting vascular ultrasound studies – typically a manual process. With a single click and in less than a minute, AVA can analyse a full vascular ultrasound scan, minimising the need for manual drawings. By significantly reducing the time taken to analyse images and generate reports, See-Mode’s AVA augments the clinical workflow, resulting in greater overall productivity, accuracy and improved patient outcomes.

Dr Milad Mohammadzadeh, co-founder and director, See-Mode Technologies, said: “Receiving our first FDA clearance is a huge step for us at See-Mode, which demonstrates the strength of the product we have built and the robustness of our approach in running clinical studies. We are extremely thankful to the outstanding group of clinicians who have worked closely with us to validate our models and build clinical evidence for the regulatory approval of AVA and our future products. Riding on this momentum, we will be ramping up our plans to bring AVA to the U.S. market within the year, to enable clinicians across the U.S. to do their work more efficiently and analyse medical images with a greater control on quality.”

Despite being a preventable disease, stroke remains a leading cause of death and disability around the world. To help clinicians better predict the risk of stroke and vascular diseases, See-Mode is developing solutions to improve the analysis of routinely collected medical images such as ultrasound, CT or MRI scans. By applying AI and computational models on these medical images, clinicians can obtain stroke risk factors that may not be accessible in current clinical practice. 

Aside from AVA, See-Mode has been building two other new products - to detect vulnerable plaque using machine learning and to identify high-risk blood flow using computational modelling. See-Mode is presently pending CE approval for AVA in Europe.