The Food and Drug Administration (FDA) has granted 510(k) clearance to Seer Home™ for the in-home diagnosis of epilepsy via multiday video monitoring.
Seer Home is an ambulatory electroencephalograph (EEG) system designed to be used at the patient’s home for week-long studies. The portable diagnostic technology depends on a wearable device, Seer Sense, which is worn around the shoulders with electrodes connected to the skull and chest to collect electrical activity in the brain (EEG) and heart (electrocardiogram [ECG]).
The EEG-ECG data is wirelessly transmitted to a monitoring hub where data is securely stored in the patient’s Seer Cloud account. Video footage is also recorded to assist physicians in the diagnosis of the neurological condition. Upon study completion, the technology is returned to clinic and the recorded data is reviewed by a physician.
“Seer has demonstrated the effectiveness of ambulant diagnostic monitoring in our home market of Australia. Now with this approval, we are delighted to be able to offer a new pathway to diagnosis for Americans with epilepsy, one that does not require a hospital stay and one that will give doctors the data they need to more accurately diagnose and monitor neurological disorders,” said Dr Dean Freestone, CEO & Co-Founder, Seer.
- Seer Medical receives FDA 510(K) clearance for ambulatory epilepsy monitoring technology. News release. Seer Medical. Accessed September 26, 2022. https://www.prweb.com/releases/2022/9/prweb18900337.htm
- Technology: Seer System. Seer Medical. Accessed September 26, 2022. https://seermedical.com/seer-system/#tab_seer-sense%3Csup%3E%C2%AE%3C/sup%3Ethe-seer-sense%3Csup%3E%C2%AE%3C/sup%3E-is-a-wearable-device-that-sits-across-the-shoulders-and-transmits-data-to-the-monitoring-hub,-where-data-is-stored-securely.
- Technology: Seer Cloud. Seer Medical. Accessed September 26, 2022. https://seermedical.com/seer-cloud/