Software Firm Must Seek PMA, FDA Warning Letter States

The FDA has escalated a long-simmering dispute with Israeli-owned software developer NeuroTrax about the proper classification of its MindStreams cognitive health assessment tool, telling the company in a warning letter it must seek Class III status or halt marketing the product. NeuroTrax is selling MindStreams’ software without 510(k) or PMA approval by the FDA, which has determined the product is high-risk and belongs in Class III, the agency said in a March 15 warning letter.
Devices & Diagnostics Letter