Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


FDA Mulls Standards For Neurodiagnostic Tools

This article was originally published in The Gray Sheet

Executive Summary

The noninvasive tests of cognitive functioning hold a great deal of promise, but have not yet been fully validated, experts said at a meeting convened by FDA.

You may also be interested in...

Despite New De Novo Clearance To Assess Brain Injury, ImPACT Concussion Assays Have Been Used For Years

US FDA granted a de novo clearance for ImPACT Applications's ImPACT and ImPACT pediatric tests to assess a patient's cognitive functions for suspected brain injury on Aug. 22, defining a new class of device, "Computerized Cognitive Assessment Aid For Concussion", but the devices have actually been in widespread use by health care providers on behalf of US parents, sporting teams, and schools since 2006, the company tells Medtech Insight.

ICER Partnering With Aetion To Scale Up Use Of RWE In Value Assessments

Aetion is also working with the US Food and Drug Administration and a number of biopharma companies on projects involving use of real-world evidence.

‘Highly Questionable’ GMP Compliance In Pakistan Prompts New Licensing System

Increased fines and penalties are on the cards for manufacturing facilities that fail to comply with proposed new requirements.





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts