Seer Medical receives FDA Clearance

The FDA approved this at-home epilepsy multi-day, video-EEG-ECG monitoring technology.

Image credit: Seer Medical

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 the 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 and 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, states a press release.

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 the 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.

About Seer Medical

Seer is reimagining how and where people undergo long-term brain and heart monitoring for faster paths to diagnoses and better patient outcomes. Seer’s solutions include an at-home epilepsy monitoring system and wearable medical devices, mobile apps for tracking and forecasting seizures, and cloud technology that translates big data into useful medical insights. Leading health and technology companies around the globe, such as the Mayo Clinic, King’s College London, Fitbit, Epiminder, and Cochlear have partnered with Seer, alongside support from the Australian and American Epilepsy Foundations. Seer is recognized as one of the world’s top private digital health companies by CB Insights, and the company has received numerous product design awards for its wearable device the Seer Sense, including a Gold IF Design Award and Good Design Awards in Social Impact and Medical and Scientific design.

Jürgen Thalmayer
October 25, 2022

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