Empatica said that its Embrace epilepsy smartband has received 510(k) clearance from FDA for use in children, a year after winning clearance for adults with epilepsy.
Embrace was designed to detect motion patterns and physiological signals that may be associated with generalized tonic-clonic (“grand mal”) seizures and immediately alert caregivers. It is the first non-EEG based, physiology-signal seizure monitoring system that FDA has cleared for use in a pediatric population, according to the Cambridge, Mass. company.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.