Nov 3, 2023

Toku secures FDA breakthrough device status for CVD retinal scan software Views: 0 Extensive research suggests the eye could provide a window to the heart. Image credit: Shuttestock/recep kart. The US Food and Drug Administration (FDA) has granted breakthrough device designation to Toku’s CLAIiR platform, which is an AI-driven software that uses retinal images to assess cardiovascular disease (CVD). Extensive research suggests the eye could provide a window to the heart. Currently, there are no FDA-cleared or approved devices that use retinal scans to indicate CVD. New Zealand-based Toku states its technology is able to provide real-time CVD assessments with similar accuracy to traditional tools such as blood tests, as per a 2 November press release. The AI software detects small details of imaged blood vessels and produces results indicating CVD risk, which are then passed on to the patient’s primary care physician. Toku added that its software is designed to be integrated into routine fundus retinal imaging cameras. An estimated 17.9 million people each year globally die from CVD, according to the World Health Organization. The FDA’s breakthrough device status gives manufacturers prioritised submission review and enhanced feedback from the agency during development. Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.