Medical-Grade Wearables on the Horizon

Fitness-tracking devices, such as Fitbit, do not require the FDA approval that medical-grade wearables do. A new wave of these devices that detect and monitor medical conditions are close to coming on the market and creating new business opportunities. The smart wearable healthcare market will grow from two billion last year to more than 41 billion by 2020, with diabetes, sleep disorders, obesity, and heart disease being the largest conditions monitored.

Companies are eager to show how these devices will improve peoples’ health and want insurance companies to cover them. Empatica has developed a wristband called Embrace, originally made to detect stress in autistic people, which alerts epilepsy patients of imminent seizures. It tracks sleep, motion, heart rate, and physiological stress. When there is a spike in electrodermal activity in one side of the body, this alerts the caregiver to check on their patient, possibly preventing sudden unexpected death which kills 1 out of every 1000 epileptic patients. Empatica hopes to develop its technology to work with other medical conditions. Embrace will start shipping out to patients early next year. Other epilepsy devices, such as SmartWatch which detects repetitive shaking, are on the market, but are not covered by insurance because they are not FDA approved.

New devices will need to not only collect data from high-tech sensors, but develop the capabilities to analyze the data. More clinical trials will gather evidence for future medical claims. Harvard Medical School’s Boston Children’s Hospital owns part of the Empatica patent and is testing different types of sensors.

Since Obamacare gives financial incentives to doctors and hospitals who keep patients healthy, these providers are eager to collect data to keep people out of the hospital. Companies such as Apple, Google, and Samsung have developed new data-gathering platforms to work with a number of chronic diseases, especially diabetes. New technology will make it possible to discover unknown signals for a variety of conditions, and unknown signals will take additional analytics.

Steenhuysen, Julie. “Beyond Fitbit: The quest to develop medical-grade wearables.” Lifestyle. Reuters, 18 Dec 2015. Web. 22 Dec 2015.

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