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

Turkey-based digital health startup h2o therapeutics has announced FDA listing of its new Apple Watch-enabled freezing of gait-cueing feature, Foggy, designed for Parkinson’s Disease patients, available via prescription as a Class II medical device. 

Utilising augmented reality, AI, and mobile-based digital therapeutics, h2o therapeutics also offers the Parky app for early detection of COVID-19. Foggy utilises the Taptic Engine to provide vibrotactile stimulation when a patient experiences freezing of gait, accessible through the Parky app by prescription. Founder Yagmur Selin Gulmus highlights the importance of accessibility and ease of use in cueing strategies.

h2o therapeutics previously received FDA clearance for the Parky app in 2022 and partnered with AmerisourceBergen in 2023 for market integration and patient engagement. Other players in the wearable monitoring market include NeuroRPM and Rune Labs, with FDA clearance for their Parkinson’s monitoring apps in 2023 and partnerships for further research and clinical platform development.

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