HeartVista said today that it won FDA 510(k) clearance for its AI-assisted One Click MRI acquisition software for cardiac exams.

The One Click system is designed to use AI-assisted software to prescribe the standard cardiac views with one click in as little as 10 seconds as the patient breathes freely. The system detects when images are below quality and uses volumetric parallel imaging acquisition to generate images of high quality in a fraction of the time.

The cardiac package is also designed to give preliminary measurements of left ventricular function, including ejection fraction, left ventricular volumes and mass.

A recent study published in the New England Journal of Medicine showed that non-invasive myocardial perfusion cardiovascular MRI stacks up with the standard invasive FFR to guide treatment for patients and lead to fewer catheterizations, according to a news release.

“This recent NEJM study further reinforces the clinical literature that cardiac MRI is the gold standard for cardiac diagnosis, even when compared against invasive alternatives,” HeartVista CEO Itamar Kandel said in prepared remarks. “Our One Click solution makes these kinds of cardiac MRI exams practical for widespread adoption. 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. Our AI solution generates definitive, accurate and actionable real-time data for cardiologists. We believe it will elevate the standard of care for cardiac imaging, enhance patient experience and access, and improve patient outcomes.”

“HeartVista’s Cardiac Package is a vital tool to enhance the consistency and productivity of cardiac magnetic resonance studies, across all levels of CMR expertise,” added Brigham and Women’s Hospital director of cardiac magnetic resonance imaging Dr. Raymond Kwong.