Clinical studies serve the purpose of validating the efficacy of the device in detecting seizures for a planned 510(k) FDA clearance and EC Directive 93/42/EEC certification.
Smart Monitor™ conducts clinical studies with leading medical institutions to determine the efficacy of the SmartWatch™ device in detecting tonic-clonic seizures. Participants are recruited from patients who are admitted to the EMU for routine video and EEG recording for routine clinical care.
- Studies at Stanford with 40 participants were concluded in June 2010. The device performed with very high sensitivity – in the high 90s as noted in the journal article: Lockman J, Fisher RS, Olson DM. Detection of seizure-like movements using a wrist accelerometer. Epilepsy and Behavior 2011;20:638-41
- Studies are currently underway at the University of California, San Francisco with pediatric patients. The device has been used on children as young as 3 years. Interim results, based on 500 hrs of testing– device sensitivity is in the high 90s, device specificity is in the 90th percentile.
Smart Monitor has also conducted in-home tests to evaluate the performance of the wristwatch for use outside the hospital as people go about their normal activities at their homes, schools, offices and elsewhere. Read our results summary.