FDA Gives Thumbs Down to Add Parkinson's Disease Assessments In Verily's Smartwatch
The FDA recently rejected an attempt by Alphabet Inc’s (NASDAQ: GOOG) (NASDAQ: GOOGL) Verily in its efforts to add a Parkinson’s disease symptom assessment to its clinical research-focused smartwatch.
Verily Study Watch is a sensor-based wearable device for non-invasive, continuous monitoring but is not commercially available.
It can collect biometric health information, such as ECG (which received 510(k) clearance in 2019), heart rate, electrodermal activity, and inertial movements.
In its rejection letter, the agency said the motor exam and Verily’s algorithm, which sought to assess the motor symptom severity in adults, are “limited in their capacity to evaluate meaningful aspects of concepts of interest that are relevant to the patients’ ability to function in day-to-day life.”
When evaluating drug efficacy in Parkinson’s disease, the FDA said it prefers content that is more representative of daily life functioning, like speech, eating, and dressing changes.
“For example, a change in rigidity or finger tapping in the MDS-UPDRS Part III cannot be directly interpreted as being meaningful to patients,” FDA said, also noting that it “is unclear how the change in the digital signature for finger tapping (as measured by the Verily Study Watch) could be interpreted as representing a meaningful change in patient function.” The company did not respond to a request for comment.
In its January letter of intent, Verily noted that its virtual motor exam was designed to mitigate the difficulties of collecting consistent data tracking the effects of various treatments on physical Parkinson’s symptoms.
Price Action: GOOG shares closed at $2,482.8 on Tuesday.
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