We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
Home » Software Firm Must Seek PMA, FDA Warning Letter States
Software Firm Must Seek PMA, FDA Warning Letter States
April 6, 2012
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.