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Smart watch epilepsy monitor cleared by FDA

Approval could potentially clear the way for insurers to reimburse its cost

FDA HQ

The US FDA has approved a smart watch developed by Empatica that can be used to track seizures and help epileptics manage their care.

The Embrace device - which is designed to detect the most dangerous types of seizures and alert caregivers via a smartphone app - has been commercially available for some time, but the FDA approval as a medical device allows it to make health claims for the device and could potentially clear the way for insurers to reimburse its cost.

According to its manufacturer, Embrace uses advanced machine learning technology or artificial intelligence to detect seizures and also analyses sleep, rest and physical activity. It was put through its paces in a 135-patient study in epileptics who were continuously monitored at a specialist unit using video electroencephalogram (EEGs) while also wearing the watch.

“From these patients, 6,530 hours of data were recorded over 272 days, including 40 generalised tonic-clonic seizures,” says Empatica. “Embrace's algorithm was shown to detect 100% of the seizures.”

The privately-held company says its device is different from other monitoring systems because aside from being much smaller it can detect multiple indicators of a seizure. It picked up EU device approval for Embrace in April last year.

A key measure is electrodermal activity or EDA, a sympathetic nervous signal that reflects physiological changes related to the ‘fight or flight’ response and was put through its paces as a diagnostic maker for seizures by MIT Media Lab researcher Rosalind Picard, who is also chief scientist at Empatica.

"It's been quite the journey,” she said after the approval was granted. “We have worked for years building wearable stress and emotion sensors, and then accidentally discovered we could pick up changes in the skin elicited by brain activity related to the most dangerous kinds of seizures.”

The approval has been welcomed by neurologist Orrin Devinsky of the Comprehensive Epilepsy Center at NYU, who believes the device “represents a major milestone” in care, given that more than 3,000 people in the US die each year from epilepsy-related sudden death.

Embrace “offers the potential to alarm family members and caretakers that a tonic-clonic seizure is occurring,” he said, adding: “The scientific evidence strongly supports that prompt attention during or shortly after these convulsive seizures can be life-saving in many cases.”

The market for wearable devices with healthcare applications is estimated to be around $6bn at the moment, ranging from activity monitors through to diagnostic and disease management aids.  A boom in growth - driven by smartphone platforms such as Apple’s ResearchKit - and growing preference for wireless connectivity among healthcare providers - is expected to see the market top $14bn in 2022, according to market researchers.

Last year, trials started of a smart watch intended to monitor symptoms in Parkinson’s disease, and wearable monitoring devices are also being deployed in clinical trials of new medicines by a number of pharma companies, including Sanofi.

Article by
Phil Taylor

7th February 2018

From: Research

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