FDA Clears Dasi Simulations’ Dimensions Imaging Software for Planning Structural Heart Procedures

September 19, 2024—Dasi Simulations recently announced that Dasi Dimensions, its second product, has earned FDA clearance.

Dasi Dimensions is a cloud-based software that uses artificial intelligence (AI) to automatically identify and measure dimensions of cardiac structures from CT scans for preprocedural planning of structural heart procedures such as transcatheter aortic valve replacement (TAVR).

According to the company, Dasi Dimensions is designed to work with the company’s PrecisionTAVI product—a predictive model platform that helps physicians improve decision-making and clinical outcomes using its interactive predictive environment accessible on mobile, tablet, or web browsers.

In 2023, Dasi Simulations announced FDA clearance for PrecisionTAVI. In January 2024, the company announced that the Centers for Medicare & Medicaid Services granted approval for a hospital outpatient billing code allowing $1,000 reimbursement per report for PrecisionTAVI.

Vinod Thourani, MD, Chair of the Dasi Medical Advisory Board, stated in the press release, “Clinical studies conducted with the AI-powered Dasi technology, coupled with cutting-edge computational modeling, have consistently demonstrated substantial improvements in patient outcomes. By reducing complications and decreasing costs, Dasi Simulations is driving a transformation in the health care landscape.”

As noted in the press release, the company was founded by Chief Technology Officer Lakshmi (Prasad) Dasi, PhD, and CEO Teri Sirset.

The technology was invented and developed in Dr. Dasi’s research lab at the Georgia Institute of Technology in Atlanta, Georgia, and was supported by National Institutes for Health’s Small Business Innovation Research funding. It has now been successfully commercialized in the United States.

“Our proprietary technology behind Dasi Dimensions and its AI was trained on a multicenter data set that is not only representative of the patient population in the United States but also ground-truthed at the highest standards for accuracy,” commented Dr. Dasi in the company press release, which further noted that each data set was ground-truthed independently by a nationally recognized group of cardiologists who specialize in cardiac imaging.

Dr. Dasi continued, “In this era of booming AI applications in medicine, we are leading the charge toward bringing advanced AI and predictive modeling products as standard of care, that have already proven to increase efficiency and improved TAVR outcomes.”

Sirset added, “Our mission—to provide an AI-powered structural heart platform that allows physicians to be more efficient and use their expertise more effectively—is moving forward with great momentum.”

Finally, Taylor Becker, Director of Products at Dasi Simulations, commented in the press release, “With the two products working in concert, physicians can save time and money on automatic sizing tasks and interactively visualize in four dimensions how different devices interact with the patient’s unique anatomy. This allows physicians insight into complication risks as well as helps plan a patient’s future interventions.”