Dasi Simulations’ Precision TAVI Predictive Modeling Tool Cleared by FDA

June 16, 2023—Dasi Simulations announced recently that it has received FDA clearance for its first product, Precision TAVI, which provides artificial intelligence (AI)–driven, individualized, computer predictive modeling in transcatheter aortic valve replacement/implantation (TAVR/TAVI). The product is intended to improve patient outcomes, enhance lifetime planning, and reduce costs associated with treating structural heart disease.

Dasi Simulations is based in Dublin, Ohio.

The foundational technology for Precision TAVI was initially licensed through The Ohio State University in Columbus, Ohio, and subsequently through an agreement between Ohio State and three Atlanta, Georgia–based institutions: Georgia Institute of Technology, Emory University, and Piedmont Hospital Atlanta.

Lakshmi (Prasad) Dasi, PhD, FACC, FAIMBE, who is Founder and Chief Technology Officer of Dasi Simulations, commented in the press release, “Dasi Simulations empowers every heart team with critical insights guaranteeing the identification of the best possible care for individual patients, customized to their unique circumstances and anatomy. One surgery at a time, our technology helps avoid complications, repeated interventions, helps lifelong planning for optimal structural heart care, and has the potential to save billions in unnecessary costs from preventable complications.”

Teri Sirset, Founder and CEO of the company, added, “Our goal is to enter into the market and demonstrate our value to physicians, providers and TAVR centers. Receiving FDA clearance is a testament to our unwavering commitment to revolutionize health care through AI technology and personalized computer simulations. Our game-changing approach has paved the way for the first approved personalized computer simulations in the heart valve space.”

Ms. Sirset continued, “While the journey to approval typically spans years, we shattered expectations by achieving this milestone in less than 14 months. As a company founded in December 2019, before the onset of the global pandemic, we navigated through unprecedented challenges and built a robust infrastructure during the tumultuous times of COVID-19. This achievement showcases our resilience and dedication to transforming patient care, one groundbreaking innovation at a time.”