Parkinson's monitoring app h2o gets FDA approval to add haptic cueing feature

Steven Loeb · April 12, 2024 · Short URL:

Foggy uses the Taptic Engine in Apple Watch to provide vibrotactile stimulation for gait freezing

Neurological diseases, such as Alzheimer’s and Parkinson's, affect over 40% of the world’s population, or 3.4 billion people, making them the leading cause of illness and disability worldwide. Neurological conditions were responsible for 443 million years of healthy life lost due to illness, disability, and premature death in 2021. 

Digital therapeutics developer h2o therapeutics uses AI, AR, and mobile technologies to make digital therapeutics, turning real-time human data into a tool for disease management.

The company offers three apps: Parky, an Apple Watch to track Parkinson’s Disease patients’ symptoms such as tremor and dyskinesia episodes; Covie, a Covid-19 early detection system consisting of a smartwatch and mobile app; and Foggy, a haptic cueing feature, which is integrated into Parky. 

Now Foggy will be able to get into the hands of more patients as h2o announced this week that it has been classified as a Class II Medical Device by the U.S. Food and Drug Administration (FDA), meaning it is now available by prescription. 

One of the features of Parkinson's disease is that it affects the patient's gait, which may freeze, meaning they temporarily can't step forward, impacts mobility and independence, often leading to falls and decreased quality of life. Foggy uses the Taptic Engine in Apple Watch to provide vibrotactile stimulation for individuals experiencing freezing of gait. Users tap a complication on their Apple Watch to initiate haptic feedback that helps with the condition. 

Foggy was developed in collaboration with the Parkinson's community, so h2o was able to gain insights into patients' specific needs and preferences. The company then conducted two clinical studies to explore different cueing methods, including audio and visual cues using augmented reality.

Parky, which enables real-time monitoring of symptoms like tremors and dyskinesia through integration with Apple Watch using the Movement Disorder API obtained 510(k) marketing clearance from the FDA in 2022.

"We're excited to launch Foggy on World Parkinson's Day, highlighting a major step in our fight against the tricky problem of freezing of gait, a condition full of unknowns," Yagmur Selin Gulmus, founder of h2o therapeutics, said in a statement.

"Foggy is a starting point towards tackling this issue that only a wealth of real-world data can clarify. Besides haptic cue generation, Foggy also acts as a data platform. This allows us to better understand freezing of gait and individualize our technology to meet the specific needs of those experiencing it."

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