The U.S. Food and Drug Administration (FDA) has issued a warning letter to O.N. Diagnostics for an uncleared update to its VirtuOst software for vertebral fracture assessment on CT scans.
According to the agency, VirtuOst VFA 3.0.0 added a new machine-learning algorithm for vertebral landmarking. The update also moved the software from a desktop application to a web-based architecture and migrated its technology platform. The FDA said each change could significantly affect the device's safety or effectiveness and requires new 510(k) submissions.
The agency asked the company to stop commercial distribution of version 3.0.0. until it addresses the issues outlined in the letter, dated September 1.
