Seer Medical receives FDA 510(K) clearance for ambulatory epilepsy monitoring technology
Announcement posted by Seer Medical 27 Sep 2022
Melbourne, Australia, September 27, 2022 — Clinical monitoring company Seer Medical has obtained U.S. Food and Drug Administration (FDA) approval of Seer Home™ for the diagnosis of epilepsy via multi-day video-EEG-ECG monitoring.
Launched in 2017, today Seer is the leading provider of epilepsy diagnostic monitoring in Australia. With this approval, Seer will be able to offer its home-based long-term monitoring to patients across America, opening up access to life-saving neurological monitoring at scale.
Epilepsy is one of the most common serious neurological conditions, affecting more than 3.4 million Americans and more than 65 million people worldwide. 150,000 people in the United States are diagnosed each year.
Clinical grade brain and heart monitoring from the comfort of the home
‘Seer Home’ is an ambulatory electroencephalograph (EEG) system designed to be used at the patient’s home for week-long studies. A wearable device - the ‘Seer Sense’ - is worn around the shoulders, with electrodes connected to the skull and chest to record brain (EEG) and heart (ECG) signals. These recordings are wirelessly transmitted to a nearby monitoring hub, which stores the data from the wearable and also records video footage synchronized to the EEG-ECG data.
The recorded video data provides additional context and information to the reviewing physician (such as body movement artifacts) to assist in diagnosis of the neurological condition. On completion of the study, the technology is returned to Seer and the collected data is reviewed and annotated by a qualified physician, producing a report for the referring doctor.
A new pathway to diagnosis for Americans
“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.
The FDA study for Seer Home was completed at the Mayo Clinic in Rochester, and in March 2022, Seer joined the inaugural cohort of the Mayo Clinic Platform_Accelerate, to undertake market validation and clinical readiness activities.
Dr Ben Brinkmann, Associate Professor of Neurology at Mayo Clinic highlighted the potential for the system to augment the monitoring capabilities of hospitals and healthcare providers.
“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,” said Dr Brinkmann.
With formal approval from the U.S. Food and Drug Administration, Seer will continue to engage with hospital networks and potential partners across the US, with sights set on addressing the backlog of patients waiting for long-term monitoring.
Breakthrough Victoria CEO Grant Dooley said Seer’s world leading technology - designed and manufactured in Melbourne - could be life changing for patients around the world.
“Breakthrough Victoria congratulates Seer Medical on achieving FDA approval to take their epilepsy monitoring technology to the United States,” Mr Dooley said. “Seer is a shining example of how investing in innovative companies as they expand globally has the potential to use Victorian technology to improve the lives of many more people across the world.”