HeartVista has received 510(k) clearance from the FDA for its artificial intelligence (AI) assisted One Click MRI acquisition software for cardiac exams. A press release reports that with HeartVista’s solution, cardiac MRI is now simple, time-efficient, affordable, and highly consistent. It adds that, prior to the HeartVista system, the use of cardiac MRI has been largely limited due to a lack of trained technologists, high costs, longer scan time, and complexity of use.
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. Furthermore, an 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 optimised 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.
Itamar Kandel, CEO of HeartVista, says: “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, minimise 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.”