Australian company Seer Medical received FDA 510(k) clearance for its at-home electroencephalograph (EEG) system Seer Home that helps providers diagnose epilepsy.
Seer has provided diagnostic at-home monitoring services in Australia since its launch in 2017, and obtaining 510(k) clearance will allow the company to expand in the American market.
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,” Dr. Dean Freestone, the company’s CEO and cofounder, said in a statement.
Ceribell developed a rapid response EEG system to help diagnose neurological patients, which the company says also addresses the need to diagnose patients suspected of having a seizure more quickly.
It recently raised $50 million to support its ongoing commercial expansion in emergency departments and intensive care units.
In the remote monitoring space, numerous companies are offering options for seizure patients.
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