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.
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.