www.fdanews.com/articles/209573-seer-medical-receives-fda-clearance-for-seer-home-system
Seer Medical Receives FDA Clearance for Seer Home System
September 28, 2022
Australia-based Seer Medical has received 510(k) clearance from the FDA for its Seer Home system for diagnosis of epilepsy.
The ambulatory electroencephalograph (EEG) system is designed for use in the patient’s home for week-long studies. It includes the wearable Seer Sense device that is worn around the shoulders with electrodes connected to the skull and chest to record brain and heart signals.
The recordings are wirelessly transmitted to a nearby monitoring hub, which stores the data and records video footage synchronized to brain and heart data.
The company plans to offer the system in the U.S. as a diagnostic tool for patients with epilepsy that would not require a hospital stay.