FDA Product Code POS: Physiological Signal Based Seizure Monitoring System
The Physiological Signal Based Seizure Monitoring System Is A Prescription Device That Uses Physiological Signal To Identify Abnormal Physiological Activity That May Be Associated With A Seizure. The System Does Not Predict Seizure Onsets, And Is Not Intended As A Standalone Seizure Monitoring Device.
Leading manufacturers include Empatica S.R.L., Brain Sentinel, Inc. and Livassured BV.
FDA 510(k) Cleared Physiological Signal Based Seizure Monitoring System Devices (Product Code POS)
About Product Code POS - Regulatory Context
510(k) Submission Activity
10 total 510(k) submissions under product code POS since 2017, with 9 receiving FDA clearance (average review time: 261 days).
Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under POS have taken an average of 176 days to reach a decision - down from 317 days historically, suggesting improved FDA processing for this classification.
POS devices are reviewed by the Neurology panel. Browse all Neurology devices →