Tuesday, June 8, 2021

Very Brief Blog; Verily and Parkinson's App: When a Clinical Standard of Care Test Flops with FDA

 To me, there's a tidbit hiding inside today's news item that a Google/Verily app to diagnose Parkinson's disease flopped with the FDA.  Here.

It's not surprising that Verily can measure finger tap speed on a smartwatch or other device.  And this is one of the most common tests in a Parkinson's disease evaluation.  However, it appears that in FDA's rejection of the device, the FDA is actually rejecting the finger tap test itself.  FDA notes that the finger tap speed "is limited in its capacity to evaluate meaningful aspects of concepts of interest that are relevant to patients' ability to funciton in day to day life."  Ouch.

Interesting and perhaps unexpected basis for rejecting something as well-known as a neurologic finger tap test.





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