Epilepsy Smartwatch Wins approval
The smartwatch watch detects when a wearer is having a convulsive seizure and lets family members know via a smartphone app.
Further, accurate tracking of when seizures happen can help get patients medical attention and aid doctors in monitoring their condition over time.
In a patient trial as part of the FDA approval, epilepsy patients suffered 40 seizures, and the watch’s algorithm spotted them all.
Worldwide, epilepsy affects roughly 50 million. The watches cost is low enough to be accessible for the millions of people in the US and Australia alone.
Startup Empatica says its Embrace smart watch is now approved by the US Food and Drug Administration as a medical device, a rare designation for a wearable.
Medical Wearables Are Rolling Out
What it means for wearables: The approval allows the firm to make medical claims about the device, and could enable people with epilepsy to have insurance pay for it. It may also encourage doctors and hospitals to use such devices.