US approval for epilepsy diagnosis technology

Melbourne-based epilepsy diagnosis company Seer Medical has gained approval for its technology to be used in US hospitals.

The US federal Food and Drug Administration (FDA) granted 510(K) clearance for Seer’s ambulatory epilepsy monitoring technology following a US clinical trial.  

Seer’s backers include impact investment firm Giant Leap Fund and state government investment body Breakthrough Victoria.

The ‘Seer Home’ technology is an electroencephalograph (EEG) system designed to be used at a patients’ homes 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 along with synchronised video footage.

The video provides additional context (such as body movements) to the reviewing specialist to assist in diagnosis. On completion of a study, the equipment is returned to Seer.

Seer’s equipment was designed in Melbourne and is now being manufactured there.

Chief executive and co-founder Dr Dean Freestone said the company had demonstrated the effectiveness of its system in Australia and had then been selected as one of a number of technologies to be tested for clinical readiness and market validation through a program at the Mayo Clinic in Rochester, New York, which started in March.

Associate Professor of Neurology at the Mayo Clinic, Dr Ben Brinkmann. said the testing had confirmed the Seer system’s potential to augment monitoring capabilities of hospitals and other healthcare facilities. He said the system could help people with epilepsy, or other episodic events, access the care they needed more quickly and with less impact to their personal lives. The technology could particularly impact underserved areas, he added.

Formal approval from the FDA should help Seer as it seeks to engage with hospital networks and potential partners across the US. The Seer technology could also help address a backlog of patients waiting for long-term monitoring.

Breakthrough Victoria chief executive Grant 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.”

Giant Leap Fund contributed to a $34 million Series A investment round for Seer last year (APE&VCJ, Sept 2021).

Other investors included hearing implant company Cochlear (ASX: COH), SG Hiscock Medical Technology Fund and multi-family office EWM Group.

Seer was founded in Melbourne in 2017 by Freestone, chief medical officer Professor Mark Cook and chief operations officer George Kenley. As a start-up, the company was a participant in the ANDHealth+ digital health commercialisation program.

In addition to Melbourne, Seer now has an office in Rochester, Minnesota.

Image: A patient using the Seer monitoring system at home.