US FDA approval for AI TAVI planning software

CardiovascularNews — June 8, 2023 – DASI Simulations has announced it has received US Food and Drug Administration (FDA) clearance for its artificial intelligence (AI) model for pre-procedural transcatheter aortic valve implantation (TAVI) modeling.

The AI—Precision TAVI—is the company’s first product to be cleared by the FDA, according to a company press release.

“Dasi Simulations empowers every heart team with critical insights guaranteeing the identification of the best possible care for individual patients, customised to their unique circumstances and anatomy,” Lakshmi (Prasad) Dasi, co-founder and chief technology officer of Dasi Simulations, said in the release. “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.”

The technology was initially licensed through The Ohio State University and subsequently through an inter-institutional agreement including Georgia Institute of Technology, Emory University and Piedmont Hospital Atlanta, according to the release.

“Our game-changing approach has paved the way for the first approved personalised computer simulations in the heart valve space,” Teri Sirset, cofounder and CEO of Dasi Simulations, said in the release. “While the journey to approval typically spans years, we shattered expectations by achieving this milestone in less than 14 months. This achievement showcases our resilience and dedication to transforming patient care, one groundbreaking innovation at a time.”


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