As digital health technologies proliferate, the US Food and Drug Administration (FDA) is taking a closer look at how they can capture information about a person’s health outside of a clinical setting.
For Parkinson’s disease, a handful of wearable technologies have already been cleared to track symptoms.
According to leading data and analytics company GlobalData, the market for neurological devices was valued at $12.5bn in 2023 and is expected to grow by a compound annual growth rate of 4.60% to reach $20.9bn by 2033.
This growth underscores the increasing importance and demand for advanced diagnostic and monitoring technologies in neurology, including those targeting Parkinson’s disease.
Apple published study results in 2021 evaluating its Motor Fluctuations Monitor for Parkinson’s disease, which uses sensors to track fluctuations in resting tremor and dyskinesia.
Later that year, a company called H2O Therapeutics received FDA 510(k) clearance for its Parky app that sends Apple Watch data to a patient’s doctor.
Last month, H2O received clearance for another app that provides haptic feedback when people experience freezing of gait symptoms.
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Other cleared apps that use Apple Watch data include Rune Labs’ StrivePD software and an app developed by digital health company NeuroRPM.
To start, the agency will ask developers, innovators, and researchers to submit AI models before 2 August 2024.
They can use public data sources or bring their own data.
Then, the FDA will pick the top performers from that group and test those models against its own freezing of gait data.
Its goal is to determine best practices for using AI models to develop and validate measures from wearable devices and smartphones.
The challenge is being hosted by the FDA’s Digital Health Center of Excellence, Office of Science and Engineering Laboratories, and Office of Digital Transformation’s precisionFDA.