FDA Clears Emerging AI-Enabled Teleradiology Platform

The Food and Drug Administration (FDA) has granted 510(k) clearance for Rology, an on-demand teleradiology platform, which is currently being utilized in nine countries, and may bolster the capabilities of stand-alone imaging centers in the United States.

In addition to facilitating seamless acquisition of DICOM images and encryption of data, Rology said the artificial intelligence (AI)-enabled teleradiology platform matches the imaging review requests with top radiologists based upon subspeciality and availability. The company noted the Rology platform has access to a network of 306 reviewing radiologists.

Rology noted the teleradiology platform features a variety of FDA-cleared modules including an automatic image acquisition tool (Rology Connect), a workflow management system and DICOM viewer. The company added that 69 percent of scans with the Rology platform undergo peer review.

Rology emphasized that the zero-footprint platform improves access to top-tier imaging, noting that 39 percent of its scan requests originate from rural areas and 46 percent of its scans have been performed for low-income patients.

"This clearance doesn't just represent technological advancement, it symbolizes hope for countless medical providers, especially (stand-alone imaging centers) and the underserved public hospitals,” emphasized Moaaz Hossam, the chief business officer of Rology. “With this platform, they can now provide world-class radiology services, ensuring that every patient, irrespective of their location or the institution's size, receives top-notch care.”