Seer Medical Receives 510(K) Clearance from FDA for Ambulatory Epilepsy Monitoring Technology

Seer Home: making reference video-EEG monitoring available at home.

“Now, with FDA clearance, Seer will be able to offer a new path to better health for Americans with epilepsy – one that doesn’t require hospital stays and that will give doctors the data they need to more accurately diagnose epilepsy and episodic disorders.”

Clinical monitoring company Seer Medical has obtained US Food and Drug Administration (FDA) approval for Seer Home™ for the diagnosis of epilepsy via multi-day video-EEG-ECG monitoring.

Launched in 2017, Seer is now the leading provider of diagnostic epilepsy monitoring in Australia. With this approval, Seer will be able to offer its long-term home monitoring to patients across America, opening up access to life-saving neurological monitoring on a large 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 BRAIN AND HEART MONITORING FROM THE COMFORT OF HOME

“Seer Home” is an ambulatory electroencephalogram (EEG) system designed for use in 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 transmitted wirelessly to a nearby monitoring hub, which stores wearable data and also records video footage synchronized with EEG-ECG data.

The recorded video data provides the examining physician with additional context and information (such as body motion artifacts) to aid in the diagnosis of the neurological condition. At the end 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 physician.

A NEW PATH TO DIAGNOSIS FOR AMERICANS

“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 to Americans with epilepsy – one that does not require hospitalization and 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 Seer.

The FDA study for Seer Home was completed at Mayo Clinic 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 system’s potential to increase 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 faster and better.” with less disruption in their personal lives. This technology can have a particularly big impact in underserved areas with limited access to neurological healthcare 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 United States in an effort to address the backlog of patients awaiting treatment. long-term monitoring.

https://www.seermedical.com/

__

Media Contact:

Sarah Gundlach, Communications and Public Relations Manager, Seer Medical

+61-403-793-609 | [email protected]

About Seer Medical

Seer is reimagining how and where people undergo long-term brain and heart monitoring for faster pathways to diagnoses and better patient outcomes. Seer’s solutions include a home epilepsy monitoring system and wearable medical devices, mobile apps for seizure tracking and prediction, and cloud technology that translates big data into useful medical information. Leading health and technology companies around the world, such as 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. Learn more about Seer at seermedical.com

About Seer Home™

“Seer Home” is an ambulatory electroencephalogram (EEG) system designed for use in 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.

Recordings are transmitted wirelessly to a nearby monitoring hub, which securely stores wearable data and also records video footage synchronized with EEG-ECG data. The recorded video data provides the examining physician with additional context and information (such as body motion artifacts) to aid in the diagnosis of the neurological condition.

At the end 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 physician. Using Seer Home monitoring improves diagnostic yield up to 30 times that of standard tests.

About the Mayo Clinic

Mayo Clinic is a nonprofit organization committed to innovation in clinical practice, education, and research, and providing compassion, expertise, and answers to all who need healing. Visit the Mayo Clinic News Network for more Mayo Clinic news.

Share the article on social networks or by e-mail:

About Michael Bill

Check Also

Edinburgh mum urges UK government to help fund high costs of medicinal cannabis for children with epilepsy

An Edinburgh mum, who has campaigned for years for cannabis oils to be prescribed by …