Alzheimer's Is A Repeat Target For FDA Breakthrough Device Path

16 Oct 2018

• By David Filmore

NeuroDiagnostics LLC said its investigational Alzheimer's disease test had been designated by US FDA as a Breakthrough Device. This is at least the third company to achieve that recognition for technology targeting Alzheimer's this year.

[Editor's Note: For details on all company-disclosed Breakthrough Device designations since the program was established in 2015, check out Medtech Insight's US Breakthrough Devices Tracker.]

A three-biomarker assay that helps identify and differentiate Alzheimer's disease is the latest technology targeted at neurodegenerative disease to gain...