Following on the heels of the approval granted to Apple Watch Series 4 for ECG screening, the US FDA has now given the green signal to another wearable mHealth device – the Embrace smart watch.
The Embrace smart watch has been approved to monitor seizure activity in children as young as age 6. Its use in adults had been approved last February.
The watch uses advanced machine learning technology to detect patterns in motion and physiological signals that may be associated with generalized tonic-clonic seizures. It then immediately alerts parents and/or the nominated caregivers, via text and phone messages, allowing them to quickly respond. It also provides sleep, rest, and physical activity analysis.
Its unique property is its use of electrodermal activity, a signal used by stress researchers to quantify physiological changes related to sympathetic nervous system activity, also known as the “fight or flight” response.
Embrace was tested in an epilepsy monitoring unit among 141 epilepsy patients, including 80 pediatric patients ages 6 to 21 years. Overall, 53 of 54 generalized tonic-clonic seizures were detected by Embrace for an accuracy rate of 98% during the clinical testing.
As the first direct-to-consumer product, the ECG app on Apple Watch Series 4 helps people to take an ECG right from their wrist, whenever they experience symptoms such as rapid or missed heart beat and also share the data with their doctors. The irregular rhythm notification feature on Apple Watch can now also monitor heart rhythms in the background and send a notification if an irregular heart rhythm is detected on five rhythm checks over a minimum of 65 minutes