h2o Therapeutics’ Apple Watch feature for Parkinson’s gets FDA medical device listing

Turkey-based digital health startup h2o therapeutics announced its new Apple Watch-enabled freezing of gait cueing feature, dubbed Foggy, designed for Parkinson’s Disease patients has received FDA listing as a Class II medical device and is available via prescription.
According to the Parkinson’s Foundation, freezing of gait is a symptom of Parkinson’s Disease in which a patient experiences a temporary, involuntary inability to move. Freezing may also affect a person’s speech or other parts of the body. 
h2o therapeutics is a company that deploys augmented reality, AI and mobile-based digital therapeutics. The company also offers an early detection Covid-19 smartwatch system named Covie.
Foggy utilizes the Taptic Engine in an Apple Watch to provide vibrotactile stimulation when a patient is experiencing freezing of gait. Users tap a complication that initiates feedback to assist with the condition. 
The feature is available through the company’s Parky app, which is accessible for Apple Watch users by prescription. 
“Cueing strategies hold immense promise in aiding individuals with freezing of gait. However, the key to their effectiveness lies in accessibility, individualization, and ease of use. Our introduction of Foggy marks a significant advancement in the field, offering patients a non-invasive solution by simply wearing their Apple Watch, designed to assist without adding cognitive load,” Yagmur Selin Gulmus, founder of h2o therapeutics, said in a statement. 
Parky received FDA clearance in 2022. The application monitors Parkinson’s symptoms such as tremors and dyskinesia. 
h2o therapeutics partnered with AmerisourceBergen in 2023 to bring the company’s Parky app to market. 
AmerisourceBergen supported h2o integration into health systems and helped generate patient engagement through AmerisourceBergen’s digital therapeutics platform. The DTx platform allows physicians to order and fulfill digital therapeutics. 
Other companies in the wearables monitoring market include Washington D.C.-based NeuroRPM and brain data startup Rune Labs. 
Rune Labs locked down FDA clearance for its Parkinson’s symptom monitoring app called StrivePD in 2022. The application also uses Apple Watch monitoring capabilities to track uncontrolled body movement. 
Rune Labs partnered with biopharma research company BlueRock Therapeutics in 2023 to further study Parkinson’s Disease using Rune Labs StriveStudy clinical platform and the company’s monitoring app StrivePD. 
NeuroRPM gained FDA clearance in 2023 for a Parkinson’s monitoring app that leverages AI to monitor common Parkinson’s symptoms such as tremors and bradykinesia. 


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