Lakshmi Prasad Dasi opened the email from the U.S. Food and Drug Administration, then the attachment.

The inventor and CTO of Dasi Simulations LLC called his co-founder, CEO Teri Sirset, as she was driving to the Dublin office.

“He’s just like, giggling, and I go, ‘Whaaat’s going on?'” Sirset said. “And then I’m the one that screamed, actually, bounced around and caused a ruckus.”

The startup’s AI-guided 3D modeling software for visualization and planning of heart valve replacement surgery received FDA clearance on May 30 as a medical device, Dasi Simulations announced Tuesday. That means wider marketing, use in more procedures and insurance reimbursement.

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