iCardio.ai Receives FDA 510(k) Clearance, Artificial Intelligence for Echocardiography A huge congratulations to the entire iCardio.ai team!
iCardio.ai is FDA Cleared ? We did it. After much sweat, strain, and ceaseless endurance through unforeseen trials, iCardio.ai received FDA 510(k) clearance for its artificial intelligence software for interpretation of echocardiography. Offering a comprehensive imaging workflow and autonomous preliminary reporting, our artificial intelligence is now available in the largest market in the world. - Our vision of the future of echocardiography–interpreted by machine: more accurate, more expedited, and more cost-effective–is coming to fruition. Gone will be the days when cardiologists read echos in the dark, like someone driving without Google Maps. We envision a future where clinicians can spend more time with their patients. - Our AI is already available in several imaging systems, thanks to our early believers–UltraLinQ Healthcare Solutions, deepc, HeartLab, and SARC MedIQ, and many others–representing exposure to millions of echocardiograms per year. The world of medicine is changing. This momentous achievement took a village. I want to foremostly thank my co-founder, Dr. Roman Sandler. Without his tireless nights and tenacity, I am not certain where iCardio.ai would be today. To our co-founder Dr. Aakriti Gupta, MD MSc, for her fervor and direction. Thank you to our regulatory team, Golnaz (Naz) Moeini, and others. Our labeling team led by Judith Buckland. Thank you, especially to our engineering talent that kept an undying belief in our mission daniel sokol, Aleksandar Stojmenski, Damjan Postolovski, Markos Muche, Anmol Nagpal, and others, David Mendelovits and Raphael Elspas. And thank you to our clinical and strategic advisors, and early investors, that never gave up hope in iCardio.ai and our team, Robert Luxenberg, Gabriel Shaya MD, MPH, Min-Yi Shih, Joshua Penn, David Yakobi, MD, Thomas A Biggs, MD, Benjamin Wessler, Matt Kozlov, Steve Persky, Evan C., Gustavo De Greiff, Jacob Kupietzky, Chris Romeo, Joe Sasson, Kinshuk Kocher, Nirdesh K Gupta, PhD and others. Finally, my deepest appreciation, and very special thank you to David Gershov, who saw us and believed in us from the very first line of code. What a milestone, what an accomplishment. How hard and long this journey has been. At last, we are FDA Cleared.