FDA Rejects Verily’s Smartwatch for Parkinson’s Assessment
The U.S. Food and Drug Administration (FDA) has rejected an application from Verily Life Sciences that sought to add a Parkinson’s disease symptom assessment tool to the company’s clinical research-focused smartwatch.
In its response letter, the FDA said there was not enough evidence that the criteria evaluated in the assessment were meaningful for patients’ lives.
Verily’s smartwatch system — a wrist-worn device called Verily Study Watch — was designed to assess the motor abilities that are affected in Parkinson’s disease based on the Movement Disorders Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), which measures disease severity and progression.
The company developed a tool, called virtual motor exam (VME) for Parkinson’s disease Part III (VME Part III of the MDS-UPDRS), to be incorporated in its smartwatch system. The VME Part III provides an estimate of the well-established MDS-UPDRS Part III Total motor score.
The watch prompts its wearer to complete eight simple motor assessments, which include tapping the smartwatch, opening and closing the hand, stomping the foot, and standing still.
According to the letter of intent that Verily submitted to the FDA in January, “the exam takes less than 20 minutes, and can be performed in the comfort of a person’s home, without the guidance of a clinician.” The aim of the system, according to Verily, is to allow for more frequent and convenient symptom assessments, which could be implemented in clinical trials.
However, the FDA was dubious about whether the data collected by the eight-part exam would reflect meaningfully on the symptoms experienced by patients in their day-to-day lives.
“For example,” the agency wrote, “a change in rigidity or finger tapping in the MDS-UPDRS Part III cannot be directly interpreted as being meaningful to patients.”
The FDA noted that changes in patients’ ability to speak, eat, and dress themselves are more relevant to patients’ daily experiences. These measures are assessed in a different section of the MDS-UPDRS, in Part II.
The agency also noted that, since the smartwatch assessment is done without the supervision of a specialist, and the results are measured by a computer algorithm, data generated from the assessment are unlikely to paint a holistic picture of patients’ motor abilities.
“For example, it is unclear how the change in the digital signature for finger tapping (as measured by Verily’s Study Watch) could be interpreted as representing meaningful change in patient function,” the FDA wrote.
“For these reasons, when evaluating drug efficacy in Parkinson’s disease, the FDA prefers content that is more representative of daily life functioning (e.g., consistent with the MDS-UPDRS Part II or other similar instruments),” the agency concluded.
Verily’s smartwatch system is currently being used to monitor symptoms in a clinical trial (NCT03364894) with Parkinson’s disease patients. The trial is recruiting participants at Radboud University in the Netherlands, which is sponsoring the trial, with plans to expand into other countries.