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h2o therapeutics Gets FDA Clearance for Parky – An Apple Watch-Based App for Parkinson’s Disease

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Parky App - h2o therapeutics - digital therapeutics

Turkey-based digital health startup h2o therapeutics has announced it has received FDA-Clearance for its prescription mobile app Parky for monitoring Parkinson’s Disease. Limited to the Apple Watch only, the Parky app monitors in real-time Parkinson’s disease symptoms such as tremors and dyskinesia (the uncontrolled, involuntary movements that affect people with Parkinson’s disease). Through Parky, medical professionals may develop a clinical profile of the patient outside the clinic – strengthening the possibility of data-driven, tailored treatment procedures – bridging the gap between real-life and in-clinic settings.

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According to the announcement, the Parky app leverages the Apple-developed Movement Disorder API. Validation of the API in a 2021 published study of 343 participants laid the foundation for h2o therapeutics and the Parky app. As MedTechDive best explains, the technology in the published research evaluated its Motor fluctuations Monitor for Parkinson’s Disease (MM4PD) system. MM4PD uses inertial sensors in the smartwatch to continuously track changes in resting tremors and dyskinesia, the uncontrolled, involuntary movements that affect people with Parkinson’s disease. 

The published research found that in 94% of cases, the Apple Watch monitoring system captured symptom changes in response to treatment that matched clinicians’ expectations. Measurements from the other 6% of patients identified opportunities to improve the treatment strategy.

h2o therapeutics Parky app for Parkinson's symptom tracking

Ten million patients worldwide live with Parkinson’s Disease, the fastest-growing neurological disorder. Parkinson’s disease (PD) occurs when brain cells that make dopamine, a chemical that coordinates movement, stop working or die. Because PD can cause tremors, slowness, stiffness, and walking and balance problems, it is called a movement disorder. Healthcare professionals in this area need reliable feedback and data for optimized treatment plans. The Parky App strengthens the possibility of data-driven, tailored treatment procedures and bridges the gap between real-life and in-clinic settings.

AS A WOMAN-FOUNDED, NON-VC-BACKED COMPANY BASED IN TURKEY, RECEIVING OUR FIRST 510(K) CLEARANCE IS A HUGE MILESTONE FOR US. WE BELIEVE PARKY WILL BRING GREAT VALUE TO THE PARKINSON’S DISEASE COMMUNITY AS AN EASILY SCALABLE AND DATA-DRIVEN PRODUCT.

Yagmur Selin Gulmus, founder of h2o Therapeutics

Parky
iPhone & Apple Watch App

h2o therapeutics’ Parky app leverages the Movement Disorder API, a tool developed by Apple. Parky monitors symptoms such as tremors and dyskinesia in real-time.

  • Tracks movement disorder symptoms such as tremors and dyskinesia
  • Medicine reminders and reporting
Parky App - h2o therapeutics - digital therapeutics

At the time of this writing (November 2022), it’s unclear whether providers can track their patients in real-time. Currently, the Parky FAQ section states that the provider portal will go live at the end of 2021. Patients can share daily, monthly, and weekly reports with their care team, but this manual process requires them to download and submit them electronically. The reports will be downloaded as PDFs containing daily, weekly, and monthly motor symptoms graphs, medication compliance, and detect falls.

As a recent Forbes article points out, FDA clearance is a relatively low bar that tests whether a product is safe to use. Parky’s implementation of Apple’s own movement disorder APIs suggests the recorded statistics should be largely reliable. This API was added to Apple’s ResearchKit platform back in 2018. Earlier this year, in June, a similar app for Parkinson’s Disease symptom tracking called StrivePD received FDA clearance and has since launched on the App Store.

h2o therapeutics – A Digital Therapeutics Company

h2o Therapeutics has two more digital therapeutics products in the pipeline based on wearable devices, and FDA submissions are planned to be completed in 2023. Using AI, AR, and mobile technologies, h2o makes real-time human data a handy tool for disease management in certain therapeutic areas. h2o currently promotes three solutions on its website.

Parky uses Apple Watch to track Parkinson’s Disease patients’ symptoms, such as tremors and dyskinesia episodes. 

Covie is a Covid-19 early detection system consisting of a smartwatch and mobile app.

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Foggy is a mobile app currently under research, leveraging augmented reality and artificial intelligence for real-time symptomatic treatments of certain neurodegenerative diseases.

Digital Therapeutics Market

In the era of digital technology, consumerism in healthcare means patients demand the same seamless digital experience they get when dealing with other service-oriented industries. Digital health tools, specifically Digital Therapeutics (DTx) that facilitate innovative methods and modalities to improve care, enable lifestyle change, and create efficiencies, are progressing quickly. Digital therapeutics deliver medical interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of diseases and disorders. Products are held to the same evidence and regulatory oversight standards as traditional medical treatments. DTx is typically used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes. These digital therapies empower patients, clinicians, and payers with intelligent and accessible tools for addressing various conditions through high-quality, safe, and effective data-driven interventions. 

As patients continue to adopt digital interactions, healthcare organizations are rapidly leveraging these technologies to improve care and the patient experience. Advancements in the increasingly dominant role of mobile technology and artificial intelligence (AI) in our daily lives have broadened PDT’s capacity in healthcare. Digital therapeutics could play a critical role in care delivery throughout the pandemic and make health care more accessible and convenient.

About h2o therapeutics

h2o therapeutics is developing digital therapeutics focusing on mobile technologies, Augmented Reality (AR), and Artificial Intelligence (AI). h2O intends to make real-time human data a handy tool for disease management in specific therapeutic areas. Their core understanding of digital therapeutics lies in the power of AI, the robustness of their clinical health research, and high levels of user engagement.

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Logan Harperhttp://curioushumans.org
With an M.S. in Organizational Leadership, my background lies within the healthcare operations and sales sector, specifically within the digital health/ digital therapeutics arena. I have a proven track record of developing and implementing effective sales strategies, establishing organizational partnerships, and creating effective product/service/sales training programs and collateral.
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