October 15, 2020
FDA Clears See-Mode Technologies’ Augmented Vascular Analysis AI Software
October 15, 2020—See-Mode Technologies announced that it has received FDA 510(k) clearance for its debut product, Augmented Vascular Analysis (AVA), a medical artificial intelligence software for automated analysis and reporting of vascular ultrasound scans for stroke prediction.
AVA was approved in Singapore in late 2019. It is commercially available in Singapore, with ongoing pilots in leading hospitals in Singapore and Australia. CE Mark approval in Europe is pending, advised the company.
According to the company, AVA uses deep learning, text recognition, and signal processing technologies to assist clinicians in interpreting and reporting vascular ultrasound studies. AVA analyzes a full vascular ultrasound scan within 1 minute, minimizing the need for manual drawings. See-Mode’s AVA is intended to augment the clinical workflow for improved overall productivity, accuracy, and patient outcomes.
See-Mode stated that it continues to add more image interpretation and reporting capabilities to AVA and is expanding the product’s capabilities to new clinical use cases.
The company is also conducting multicenter clinical studies in Europe and the United States for two other new products: one to detect vulnerable plaque using machine learning and another to identify high-risk blood flow using computational modeling.