---
title: 'Regulatory Daily Summary: What Happened on October 26, 2026'
headline: FDA cites VirtuOst software changes in O.N. Diagnostics warning
description: The agency said a new algorithm and platform changes left the products
adulterated and misbranded.
url: https://thebench.bio/news/regulatory/2026-10-26
topic: regulatory
date: '2026-10-26'
covers:
- '2026-10-26'
date_published: '2026-10-26T12:04:20Z'
date_modified: '2026-10-26T12:04:20Z'
tags:
- Regulatory
sources: 1
publisher: TheBench.Bio
---
# 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]
## Also published
- [FDA Alignment Is a Starting Point, Not a Rare Disease Strategy for the European Market](), MedCity News
## Sources
1. [If You Change It, FDA Will Come: What the O.N. Diagnostics Warning Letter Means for SaMD Modifications](), FDA Law Blog, 2026-10-26
---
TheBench.Bio wrote this from the reporting cited above, with a language model drafting and editing.
[1]: