Dasi Simulations has announced that its second product—Dasi Dimensions—has earned US Food and Drug Administration (FDA) clearance.
“Our mission—to provide an artificial intelligence (AI)-powered structural heart platform that allows physicians to be more efficient and use their expertise more effectively—is moving forward with great momentum,” said Teri Sirset, founder and CEO, following the milestone.
Dasi Dimensions uses AI to automatically identity and measure dimensions of cardiac structures from computed tomography (CT) scans for pre-procedural planning of structural heart procedures such as transcatheter aortic valve implantation (TAVI).
It is a cloud-based software that eliminates the time currently spent by physicians or users identifying landmarks and making measurements.
“Our proprietary technology behind Dasi Dimensions and its AI was trained on a multicentre dataset that is not only representative of the patient population in the USA but also ground-truthed at the highest standards for accuracy,” said Lakshmi (Prasad) Dasi, founder and chief technology officer.
Each dataset was checked for accuracy independently by a group of cardiologists who specialise in cardiac imaging.
“Clinical studies conducted with the AI-powered Dasi technology, coupled with cutting-edge computational modelling, have consistently demonstrated substantial improvements in patient outcomes. By reducing complications and decreasing costs, Dasi Simulations is driving a transformation in the healthcare landscape,” said Vinod Thourani (Piedmont Heart Institute, Atlanta, USA), chair of the Dasi medical advisory board.
Supported by National Institutes of Health (NIH) Small Business Innovation Research funding, Dasi Dimensions is designed to work in concert with the company’s previously FDA cleared and Centers for Medicare & Medicaid Services (CMS) reimbursable PrecisionTAVI product—a novel predictive model platform that helps physicians improve decision making and clinical outcomes using its interactive predictive environment accessible on mobile, tablet, or web browsers.
“With the two products working in concert, physicians can save time and money on automatic sizing tasks and interactively visualise in 4D 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,” said Taylor Becker, director of product.
“In this era of booming AI applications in medicine, we are leading the charge towards bringing advanced AI and predictive modelling products as standard-of-care, that have already proven to increase efficiency and improved TAVI outcomes,” said Dasi.