See-Mode Technologies Receives FDA Clearance for its Debut Product, AVA

See-Mode Technologies Receives FDA Clearance for its Debut Product, AVA

AVA uses text recognition, deep learning, and signal processing technologies to assist clinicians in interpreting and reporting vascular ultrasound studies

Fremont, CA: See-Mode Technologies, a MedTech startup based in Singapore and Australia that helps 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), a world-first medical Artificial Intelligence (AI) software for automated analysis and reporting of vascular ultrasound scans.

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

"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," said Dr Milad Mohammadzadeh, Co-Founder and Director, See-Mode Technologies.

Despite being a highly preventable disease, stroke remains one of the key reasons behind the increased medical mortality rate around the world. To help clinicians better predict the risk of stroke and vascular diseases, See-Mode is developing novel 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. The startup has completed strong proofs-of-concept for both products with collaborators in Singapore and Australia, and multi-centre clinical studies are now being conducted with partners across Europe and the United States.

See-Mode continues to add more image interpretation and reporting capabilities to AVA and is expanding the product's capabilities to new clinical use cases. AVA has been approved by the Singapore Health Sciences Authority (HSA) as a Class B medical device in late 2019, and available in Singapore, with ongoing pilots in leading hospitals in Singapore and Australia.