This article is more than 5 years old. Information may no longer be current.
AI-assisted cardiac MRI image acquisition software receives FDA clearance
Click Here to Manage Email Alerts
HeartVista announced that it received 510(k) clearance from the FDA for its AI-assisted MRI acquisition software for cardiac exams.
The system (Cardiac Package for OneClick) uses AI-assisted software to prescribe the standard cardiac views in as short as 10 seconds with one click, while the patient breathes freely, according to a press release issued by the company.
Using an artifact detection neural network, the software identifies when the image quality is below the acceptable threshold and prompts the operator to reacquire the images in question, if needed, the company stated in the release.
In addition, the software provides preliminary left ventricular function measurements including ejection fraction, LV volumes and LV mass.
The product “is a vital tool to enhance the consistency and productivity of cardiac magnetic
resonance studies, across all levels of CMR expertise,” Raymond Kwong, MD, MPH, director of cardiac magnetic resonance imaging at Brigham and Women’s Hospital and associate professor of medicine at Harvard Medical School, said in the release.
The system “makes these kinds of cardiac MRI exams practical for widespread adoption,” Itamar Kandel, CEO of HeartVista, said in a press release. “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.”
He noted that cardiac MRI may become more popular after the publication of the MR-INFORM study, in which, as Healio previously reported, cardiac MRI was noninferior to an invasive strategy supported by fractional flow reserve for initial management of patients with stable angina and intermediate-to-high risk for CAD.
Disclosure: Kandel is an employee of HeartVista. Kwong reports he received research grants from Alnylam, Bayer, GlaxoSmithKline, Myokardia and Siemens.