HeartVista—a company focused on AI-powered MRI solutions—has received 510(k) clearance from the FDA for its AI-assisted One Click MRI software, the first system of its kind, according to a company announcement.
The Los Altos, California-based company’s cardiac system automatically recommends cardiac views with one click, enabling more efficient and cost-effective cardiac MRI exams.
“Patients across the country now have access to the only AI-guided cardiac MRI exam, which will deliver continuous imaging via an automated process, minimize errors and simplify scan operation,” Raymond Kwong, MPH, director of cardiac magnetic resonance imaging at Brigham and Women’s Hospital, said in the announcement.
Kwong also noted the outcomes of the recent MR-INFORM study published in the New England Journal of Medicine that found non-invasive myocardial perfusion cardiac MRI performed as well as invasive FFR—once the “gold standard” to treat patients with stable chest pain.
“Our AI solution generates definitive, accurate and actionable real-time data for cardiologists,” Kwong added. “We believe it will elevate the standard of care for cardiac imaging, enhance patient experience and access, and improve patient outcomes.”