FDA Lists Apple Watch's 'Foggy' As A Class II Device For Parkinson’s Gait Freezing

In a significant development for individuals grappling with Parkinson's disease, h2o therapeutics has unveiled Foggy, a pioneering haptic cueing feature now accessible by prescription. Recognized as a Class II Medical Device by the U.S. Food and Drug Administration (FDA), Foggy emerges as a beacon of hope for millions affected by this neurological condition. Parkinson's disease, known for its profound impact on mobility and quality of life, often manifests through freezing of gait - a temporary yet debilitating inability to move forward.

Foggy leverages the Taptic Engine in Apple Watch to deliver vibrotactile stimulation, aiming to alleviate the challenges associated with freezing of gait. By simply activating a complication on their Apple Watch, users receive haptic feedback designed to aid their movement. Yagmur Selin Gulmus, the visionary founder of h2o therapeutics, emphasized the potential of cueing strategies in enhancing the lives of those facing this symptom. "Our goal with Foggy is to offer an accessible, personalized, and straightforward solution that integrates seamlessly into the patient's daily life without overwhelming them," Gulmus stated.

The journey to Foggy's creation involved extensive research, including two clinical studies focusing on various cueing methods such as audio and visual cues augmented by reality technology. Collaborating with the Parkinson’s community allowed h2o therapeutics to tailor Foggy to meet the nuanced needs of individuals living with the disease. Launched on World Parkinson's Day, Foggy not only represents a step forward in addressing freezing of gait but also serves as a platform for gathering valuable data to further refine and personalize the technology.

In 2022, h2o therapeutics achieved a milestone by securing 510(k) marketing clearance from the FDA for Parky, its prescription mobile app dedicated to monitoring Parkinson’s Disease. The integration of Foggy into Parky enhances the app’s functionality, offering a comprehensive approach to symptom management. Through its connection with Apple Watch and utilization of the Movement Disorder API, Parky facilitates real-time monitoring of symptoms such as tremors and dyskinesia. With the addition of Foggy, the app now provides even more robust support for patients, enabling effective communication of crucial data between patients and healthcare providers.

This innovation underscores h2o therapeutics' commitment to advancing digital therapeutic solutions for Parkinson's disease. By harnessing wearable technology and data analytics, Foggy and Parky collectively aim to improve understanding and management of this complex condition, marking a significant stride in enhancing patient care and independence.