Seer Medical Receives FDA 510(okay) for Serving to With Epilepsy Analysis at Residence

australian firm Medical mild obtained 510(okay) clearance from the FDA for its Seer Residence electroencephalograph (EEG) system that helps suppliers diagnose epilepsy.

Seer Residence’s EEG system permits sufferers to endure week-long research at house. Sufferers put on a tool – the Seer Sense – round their shoulders with electrodes linked to the affected person’s cranium and chest to document mind (EEG) and coronary heart (ECG) alerts. This information is then despatched wirelessly to a close-by monitoring hub which shops it together with video footage synchronized with the EEG/ECG information, offering extra context round physique movement artifacts.

On the finish of the research, the info collected is reviewed and annotated by a physician who then produces a report for the referring physician.

Seer has been offering house diagnostic companies in Australia since its launch in 2017, and acquiring 510(okay) clearance will enable the corporate to broaden into the US market.


Being identified with epilepsy in the USA is usually a complicated course of. This typically requires medical doctors to carry out a number of checks within the workplace or hospital, and pinpointing the onset of seizures within the mind could require a number of checks.

“Seer has demonstrated the effectiveness of outpatient diagnostic monitoring in our house market of Australia. Now, with this approval, we’re thrilled to have the ability to provide a brand new diagnostic pathway for Individuals with epilepsy – one that doesn’t require hospital keep and one that may present physicians with the info they should extra precisely diagnose and monitor neurological problems,” stated Dr. Dean Freestone, CEO and co-founder of the corporate, in a press release.


Ceribell has developed a rapid-response EEG system to assist diagnose neurological sufferers, which the corporate says additionally addresses the necessity to extra shortly diagnose sufferers suspected of getting a seizure. It lately raised $50 million to assist its ongoing enterprise enlargement into emergency departments and intensive care models.

Within the discipline of distant monitoring, many firms provide choices for seizure sufferers.

Embrace2 is a wearable seizure monitoring system that has obtained FDA clearance and can be utilized by youngsters six years of age and older.

In February 2022, Epitel, maker of a wearable EEG system for seizure detection, raised $12.5 million in Collection A funding. The platform has obtained 501(okay) clearance from the FDA to be used within the hospital of its REMI system in March 2021, however deliberate to broaden to outpatient and residential care. The February funding spherical can be used for the commercialization of its system and additional growth of its platform.