The company’s Cardiac Package deploys AI-assisted software to prescribe the standard cardiac views within 10 seconds, facilitating the patient breath freely
Image: FDA approves HeartVista’s cardiac MRI scan solution One Click. Photo: Courtesy of Michal Jarmoluk from Pixabay.
US-based MRI solutions provider HeartVista has secured the US Food and Drug Administration (FDA) 510(k) approval for its AI-assisted One Click MRI acquisition software for cardiac exams.
HeartVista is focused on improving access to MRI and improved patient care by leverages artificial intelligence, and its new One Click software platform enables real-time MRI for a variety of clinical and research applications.
HeartVista CEO Itamar Kandel said: “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. 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.”
One Click is designed to facilitate simple and affordable cardiac MRI
Cardiac MRI, which is also called cardiac magnetic resonance (CMR), offers several advantages. However, the lack of trained technologists, high costs, long scan time, and complexity would limit the use of cardiac MRI.
To address this, HeartVista has developed a new solution, which makes the cardiac MRI simple, time-efficient, affordable, and highly consistent.
HeartVista said that its FDA approved Cardiac Package deploys AI-assisted software to prescribe the standard cardiac views within 10 seconds, facilitating the patient breath freely.
The company has incorporated an advanced artifact detection neural network in its protocol to identify when the image quality is below the threshold, and prompt the operator to reacquire the low quality images if needed.
In addition, a 4D flow measurement application generates high quality images in a less time through a non-cartesian, volumetric parallel imaging acquisition, to provide preliminary measures of left ventricular function including ejection fraction, left ventricular volumes, and mass.
HeartVista intends to present the new One Click Cardiac Package at the Radiological Society of North America (RSNA) annual meeting in Chicago, US.
Harvard Medical School associate professor of medicine Raymond Kwong said: “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.”