December 23, 2015 admin

FDA Ally For Health Tech?  Medical–Grade Wearables- Reuters Reports

“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.”

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