Ezra announces that the U.S. FDA has granted 510(k) clearance to its artificial intelligence, Ezra Flash, which helps improve MRI quality. The company will use this technology to launch a 30-minute, full-body MRI scan.
Ezra trained the AI to assess which elements of the MRI scan are essential to creating a complete and accurate image. This allowed Ezra to enhance image quality in high-speed MRI scans that are at the limits of the current standard of care. Ezra used a multi-step validation process in which a panel of five radiologists analyzed the performance of the AI both qualitatively and quantitatively. These medical experts were instrumental in choosing an AI model that can enhance MR images without obscuring any existing pathology, Ezra officials say.
Daniel K. Sodickson, MD, PhD, the chief of innovation and director of the Center for Advanced Imaging Innovation and Research at New York University’s radiology department, worked with Ezra’s team of AI researchers to develop Ezra Flash.
“The FDA clearance of Ezra Flash is an important landmark—the beginning of a sea change in how medical imaging is used,” says Sodickson. “Progressive increases in imaging speed over time have already resulted in myriad benefits to patients and physicians. Until now, though, imaging has principally been used for the diagnosis and characterization of disease once other signs and symptoms have already developed.”
Ezra, on the other hand, is using MRI as a tool for early detection of cancer prior to the development of symptoms—a safety net of proactive monitoring that has previously only been available to patients with certain well-established risk factors, Ezra officials say. Specifically, Ezra Flash will increase the accessibility of early-warning MRI, and Ezra’s dataset of repeated scans over time will help it to prevent false positives and ensure that the warnings it provides are appropriate .
Ezra’s Full Body MRI is available in New York, Los Angeles, San Francisco, Miami, and Las Vegas. The company will be rolling out its services to more cities in the second half of 2023.