Beyond Fitbit: The quest to develop medical-grade wearables

Fri Dec 18, 2015 10:31am EST
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By Julie Steenhuysen

CHICAGO (Reuters) - A new wave of wearable computing devices that detect and monitor serious diseases is moving from the laboratory to the market, potentially transforming the treatment of conditions ranging from epilepsy to diabetes and creating business opportunities estimated to be worth tens of billions of dollars.

Unlike popular fitness-tracking devices, such as Fitbit Inc's Fitbit and Jawbone's UP wristbands, these so-called medical-grade wearables require approval from the U.S. Food and Drug Administration - a rigorous regulatory hurdle that first-generation wearables sought to avoid.

The FDA is preparing for the coming onslaught.

Bakul Patel, FDA's associate director for digital health, told Reuters the agency is reviewing applications for three new senior health scientist positions focused on digital health.

Long criticized by some health-tech entrepreneurs as a barrier to innovation, the FDA is now seen as an important ally by companies eager to show that their devices can improve peoples' health - and eager to get heath insurers to cover them.

"Consumers, doctors, payers all want to know if a product provides a clinical benefit," said Julie Papanek of the venture capital firm Canaan Partners, who invests in wearables startups. "Working with the FDA is the one way to get the ability to market that benefit."

Many would-be vendors of medical wearables are small startup companies, such as Cambridge, Massachusetts-based Empatica, which is developing a wristband designed to alert epilepsy patients and their caregivers of seizures in the hope of averting a dangerous post-seizure condition that can cause sudden, unexpected death.

Like many emerging wearables companies, Empatica hopes that its core technology will also find uses far beyond one specific medical condition. Empatica founder Rosalind Picard, a Massachusetts Institute of Technology professor and inventor, told Reuters the company has just started large clinical trials using its wristband device on individuals with depression.   Continued...

Rosalind Picard, MIT professor and chief scientist at Empatica, and Matteo Lai (L), CEO of Empatica, wear the company's Embrace devices while talking at the Massachusetts Institute of Technology in Cambridge, Massachusetts November 25, 2015.    REUTERS/Brian Snyder