iCardio.ai Receives FDA 510(k) Clearance, Artificial Intelligence for Echocardiography

iCardio.ai Receives FDA 510(k) Clearance

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. We want to foremostly thank our co-founder, Dr. Roman Sandler, for leading the charge. Dr. Aakriti Gupta, MD MSc, for her fervor and direction. Thank you to our regulatory team, Golnaz 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, Kinshuk Kocher, Nirdesh K Gupta, PhD and others. Finally, my deepest appreciation, a 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. Alas, we are FDA Cleared. 

So where do we go from here? 

iCardio.ai has already begun mobilizing its commercial operations with integrations in several partner systems. The revenue forecasted will be used to drive our future company ambitions.

EchoMeasure is our first FDA Cleared software product, which supports a robust reading workflow for automated echocardiographic interpretation. The clearance for this system will act as the foundation on which future algorithms will be supported, namely our structural heart disease detection algorithm suite. Some of our algorithms can be used to detect valvular heart disease and have already garnered much attention from health systems and prosthetic valve manufacturers. 

The AI Thesis

Artificial intelligence has already transformed industries, though we see these advancements siloed to specific domains. Example, Tesla’s autonomous driving, which was trained on billions of miles of driving data, or OpenAI’s ChatGPT for interacting with and generating general knowledge, trained on the corpus of the internet. The domain of medical imaging remains largely untapped. Accessing large imaging datasets for training AI systems remains challenging, owing to the bureaucratic hurdles required to access and organize institutional data. iCardio.ai continues to operate within the wave of first-mover advantage. With access to data, talent, distribution, and now FDA regulatory clearance, the moat we carved is deeper than ever. As a company, we are meeting our potential of changing medicine and fulfilling our mission of building the next evolution of echocardiography.

With much excitement for the future. 

Joseph & the rest of the iCardio.ai Team

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