Wednesday, May 01, 2024
Toku a leading medical device company specializing in imaging technology and AI, has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to its MyKidneyAI technology. MyKidneyAI employs AI to analyze retinal images gathered during routine eye exams to identify elevated chronic kidney disease (CKD) risk in individuals with diabetes. This development is crucial as many people with diabetes do not undergo regular CKD screening, resulting in late-stage detection when interventions are less effective.
Professor of Medicine (Nephrology) and Epidemiology and Population Health at Stanford University School of Medicine, highlighted the significance of MyKidneyAI in detecting CKD early. By examining retinal microvasculature, MyKidneyAI can identify signs of CKD risk, offering a non-invasive solution available in eye care or primary care settings. Toku is collaborating with its strategic investors, Topcon Healthcare and National Vision, to make MyKidneyAI accessible in the U.S. market, potentially transforming CKD screening.
CKD affects a substantial portion of the U.S. population, yet many individuals are unaware of their condition until it reaches advanced stages. The economic burden of managing CKD is significant, with Medicare spending over $130 billion annually, emphasizing the need for early identification and intervention.
Toku's CEO, Ehsan Vaghefi, expressed pride in achieving two FDA Breakthrough designations within a year, highlighting the company's commitment to innovative healthcare solutions. The expedited review process facilitated by the Breakthrough designation accelerates the deployment of technologies like MyKidneyAI to benefit patients sooner.
Senior Vice President of Healthcare Strategy and Development at National Vision, emphasized the importance of leveraging innovative technologies like AI to improve patient outcomes, acknowledging their transformative potential across medical disciplines.
President of Topcon Healthcare, Inc., reiterated their support for Toku's mission of advancing healthcare through innovation.
Toku's MyKidneyAI technology represents a significant advancement in early CKD detection, with the potential to alleviate the burden of this condition on both patients and healthcare systems.
Source: businesswire.com
