February 5, 2018
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...
April 11, 2016
Doctors at an emergency room in New Jersey used data from a patient's Fitbit activity tracker -- which they happened to notice on his wrist -- to determine his course of treatment.
When the 42-year-old patient showed up in the ER at Our Lady of Lourdes Medical Center in Camden, New Jersey, he had already had a seizure and he had atrial fibrillation. Doctors had to decide whether or not to use an...