The Food and Drug Administration (FDA) has rejected Verily’s application to use a smartwatch to assess the severity of Parkinson’s disease remotely. The smartwatch reminds patients to complete a range of motor tasks weekly. The device is meant to track any changes in disease progression, but the FDA noted that the smartwatch data might not correlate with altered day-to-day function. Verily could decide to modify its device and may turn to former FDA principal deputy commissioner Dr. Amy Abernethy, now president of Verily’s clinical research business, for assistance.
“The FDA also suggested that since Verily’s assessment is performed without clinical supervision and then quantified by a software algorithm, it may not paint a complete picture of changes in a patient’s motor abilities.” Read more here.
(Source: Andrea Park, Fierce Biotech, 6/8/21)