australian company Medical light received 510(k) clearance from the FDA for its Seer Home electroencephalograph (EEG) system that helps providers diagnose epilepsy.
Seer Home’s EEG system allows patients to undergo week-long studies at home. Patients wear a device – the Seer Sense – around their shoulders with electrodes connected to the patient’s skull and chest to record brain (EEG) and heart (ECG) signals. This data is then sent wirelessly to a nearby monitoring hub which stores it along with video footage synchronized with the EEG/ECG data, providing additional context around body motion artifacts.
At the end of the study, the data collected is reviewed and annotated by a doctor who then produces a report for the referring doctor.
Seer has been providing home diagnostic services in Australia since its launch in 2017, and obtaining 510(k) clearance will allow the company to expand into the US market.
WHY IS IT IMPORTANT
Being diagnosed with epilepsy in the United States can be a complex process. This often requires doctors to perform multiple tests in the office or hospital, and pinpointing the onset of seizures in the brain may require multiple tests.
“Seer has demonstrated the effectiveness of outpatient diagnostic monitoring in our home market of Australia. Now, with this approval, we are thrilled to be able to offer a new diagnostic pathway for Americans with epilepsy – one that does not require hospital stay and one that will provide physicians with the data they need to more accurately diagnose and monitor neurological disorders,” said Dr. Dean Freestone, CEO and co-founder of the company, in a statement.
THE GREAT TREND
Ceribell has developed a rapid-response EEG system to help diagnose neurological patients, which the company says also addresses the need to more quickly diagnose patients suspected of having a seizure. It recently raised $50 million to support its ongoing business expansion into emergency departments and intensive care units.
In the field of remote monitoring, many companies offer options for seizure patients.
Embrace2 is a wearable seizure monitoring device that has received FDA clearance and can be used by children six years of age and older.
In February 2022, Epitel, maker of a wearable EEG system for seizure detection, raised $12.5 million in Series A funding. The platform has received 501(k) clearance from the FDA for use in the hospital of its REMI system in March 2021, but planned to expand to outpatient and home care. The February funding round would be used for the commercialization of its system and further development of its platform.