Empatica's Embrace, the consumer-facing wearable for epileptic seizure detection, received 510(k) clearance from the FDA last month. The wearable, which has already been used in clinical trials by pharma company Sunovion, has a long history that's led it up to this milestone.
The clearance is as a prescription, not an over-the-counter device, which means users will have to secure a prescription from their neurologist to use the device's seizure-detecting features.
"There’s been a lot of talk about devices, mobile technologies, and also artificial intelligence in healthcare, but when you look at the results there’s very little," Empatica CEO Matteo Lai told MobiHealthNews. "But this is one of the results — the fact that a smartwatch that looks like any other consumer smartwatch has been approved by the FDA."
The Empatica Embrace is the latest version of a wearable developed by Rosalind Picard, an MIT professor who formerly cofounded a company called Affectiva. Back in late 2011, Affectiva launched an emotional arousal wearable called the Q-sensor based on Picard's research on children with epilepsy at Boston Children's Hospital. In April 2013, though, as MobiHealthNews reported at the time, Affectiva discontinued the Q-sensor and refocused the company on emotional analysis for advertising focus groups. Picard left the company and joined up with Empatica, a company founded by Lai and Simone Tognetti that was focused on creating a similar wearable.
Empatica developed a clinical version of the sensor called E3, but turned to Indiegogo to fund Embrace, the consumer version of the device, in January 2015. The company ultimately raised $782,666 — more than five times its goal.
Lai told MobiHealthNews at the time that the company decided to transition into a consumer device because the need is so great.
"You might have quite a few friends that have epilepsy but they never told you," he said. "One in every 26 people suffers from epilepsy during their lifetime. And 1 percent of the population suffers during any given time."
Lai also said back in 2015 that people with epilepsy often don't want to admit it or have it widely known, so the important thing in creating a consumer device was that it be easy to use but also attractive to wear. Since the company plans to market the device to anyone who might want to use it for tracking stress, activity, or sleep, wearing it doesn't necessarily broadcast that the user has epilepsy.
"It’s a good-looking device," he said. "It’s the first time a medical device looks beautiful and is something that you want to wear, not something to be ashamed of or a patch that you have to hide on your body because it’s ugly to look at."
Empatica has been seeking FDA clearance since 2015, but was able to crowdfund and sell the device in the meantime by offering it as a generalized health tracker/smartwatch and requiring US users to sign up for a clinical trial in order to use the Alert app, which allows the wearable to detect seizures and alert family members or caregivers.
Empatica offers the device for $249, with an additional monthly subscription fee to use the alert features. Without those features, users can still record symptoms in a diary and learn how their seizures correlate with things like diet, exercise, and sleep. Empatica is also collecting data on those connections, in the hopes of eventually creating a device that can not only detect seizures, but predict (and help prevent) them as well.