The U.S. Food and Drug Administration (FDA) has issued a warning letter to O.N. Diagnostics for an uncleared update to its VirtuOst VFA 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 require new premarket notification.
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.
"In response to FDA’s concerns, O.N. Diagnostics is completing verification and validation of a revised version of VirtuOst VFA that removes the machine-learning functionality identified in the warning letter and incorporates updated cybersecurity controls and documentation consistent with applicable FDA guidance," a spokesperson for O.N. Diagnostics told AuntMinnie.
The company is also implementing broader quality-system corrective actions and will continue working with FDA as those activities are completed. In the meantime, VirtuOst VFA remains available for clinical care through O.N. Diagnostics’ existing in-house service, O.N. Diagnostics said.
