HeartVista Receives FDA 510(k) Clearance for One Clicktm Cardiac MRI Package, the First AI-assisted Cardiac MRI Scan Solution

HeartVista, a pioneer in AI-assisted MRI solutions, today announced that it received 510(k) clearance from the U.S. Food and Drug Administration to deliver its AI-assisted One Clicktm MRI acquisition software for cardiac exams. Despite the many advantages of cardiac MRI, or cardiac magnetic resonance (CMR), its use has been largely limited due to a lack of trained technologists, high costs, longer scan time, and complexity of use. With HeartVista's solution, cardiac MRI is now simple, time-efficient, affordable, and highly consistent.

"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," said Dr. Raymond Kwong, MPH, Director of Cardiac Magnetic Resonance Imaging at Brigham and Women's Hospital and Associate Professor of Medicine at Harvard Medical School.

A recent multi-center, outcome-based study (MR-INFORM), published in the New England Journal of Medicine, demonstrated that non-invasive myocardial perfusion cardiovascular MRI was as good as invasive FFR, the previous gold standard method, to guide treatment for patients with stable chest pain, while leading to 20% fewer catheterizations.

"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," said Itamar Kandel, CEO of HeartVista. "Our One Clicktm 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 FDA-cleared Cardiac Package uses AI-assisted software to prescribe the standard cardiac views with just one click, and in as few as 10 seconds, while the patient breathes freely. A unique artifact detection neural network is incorporated in HeartVista's protocol to identify when the image quality is below the acceptable threshold, prompting the operator to reacquire the questioned images if desired. Inversion time is optimized with further AI assistance prior to the myocardial delayed-enhancement acquisition. A 4D flow measurement application uses a non-Cartesian, volumetric parallel imaging acquisition to generate high quality images in a fraction of the time. The Cardiac Package also provides preliminary measures of left ventricular function, including ejection fraction, left ventricular volumes, and mass.

HeartVista is presenting its new One Clicktm Cardiac Package features at the Radiological Society of North America (RSNA) annual meeting in Chicago, on Dec. 4, 2019, at 2 p.m., in the AI Showcase Theater. HeartVista will also be at Booth #11137 for the duration of the conference, from Dec. 1 through Dec. 5.

About HeartVista

HeartVista believes in leveraging artificial intelligence with the goal of improving access to MRI and improved patient care. The company's One Clicktm software platform enables real-time MRI for a variety of clinical and research applications. Its AI-driven, one-click cardiac localization method received first place honors at the International Society for Magnetic Resonance in Medicine's Machine Learning Workshop in 2018. The company's innovative technology originated at the Stanford Magnetic Resonance Systems Research Laboratory. HeartVista is funded by Khosla Ventures, and the National Institute of Health's Small Business Innovation Research program.

For more information, visit www.heartvista.ai