Regulatory Daily Summary
Regulatory Daily Summary: What Happened on October 26, 2026
FDA cites VirtuOst software changes in O.N. Diagnostics warning
The agency said a new algorithm and platform changes left the products adulterated and misbranded.
Today in brief
O.N. Diagnostics received an FDA warning letter over changes to its VirtuOst software products, issued September 1, 2026, and posted by the agency October 6.1 FDA said the products were adulterated and misbranded after the company introduced a new machine-learning algorithm and moved them to web-based software on a different technology platform.1