Australia-based clinical monitoring company Seer Medical has secured the US Food and Drug Administration (FDA) approval for its ambulatory monitoring system, Seer Home.
Seer Home is an electroencephalograph (EEG) system, indicated for the diagnosis of epilepsy through multi-day video-EEG-ECG monitoring.
It comes with Seer Sense, a wearable device worn around the shoulders with electrodes connected to the patient’s skull and chest to record brain (EEG) and heart (ECG) signals.
The recordings are wirelessly transmitted to the closest monitoring hub, which stores the data and records the video footage synchronised to the EEG-ECG data.
The data is said to provide the physicians with additional context and information to help diagnose the neurological condition.
Seer Home is designed for at-home use by the patients to support the week-long studies.
Upon completion of the study, the system is returned to Seer, the data collected is reviewed and annotated by a qualified physician, and a report is created for the referring doctor.
Seer CEO and co-founder Dean Freestone said: “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.”
With the FDA approval, the epilepsy diagnostic monitoring company is enabled to offer its home-based long-term monitoring to patients across the US.
The company will engage with hospital networks and potential partners across the US to address the backlog of patients waiting for long-term monitoring.
In March this year, Mayo Clinic in Rochester completed an FDA study for Seer Home.
Seer joined the inaugural cohort of the Mayo Clinic Platform_Accelerate, to commence market validation and clinical readiness activities.
Mayo Clinic associate professor of neurology Ben Brinkmann said: “Seer’s wireless EEG monitoring system and AI-enabled review platform have potential to help people with epilepsy or other episodic events access the care they need more quickly and with less disruption to their personal lives.
“This technology may be especially impactful in underserved areas with limited access to neurological health care resources.”
