Australia-based company Epiminder has received Food and Drug Administration (FDA) authorisation through the De Novo classification for its implantable continuous electroencephalogram (EEG) monitoring system (iCEM), Minder, designed for individuals with epilepsy.
This system has also gained breakthrough technology designation from the agency for individuals with this condition.
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Epiminder noted that the Minder system addresses the limitations of existing EEG technologies by offering actionable diagnostic information, which is crucial for the management of epilepsy.
Instrumental in validating the safety of the system was a multi-centre, open design, prospective, case-controlled trial, UMPIRE, which was conducted in hospitals in Australia from 2019 to 2023.
Outcomes from this trial supported the application to the US regulator.
The company plans a formal US launch of the device in the second half of this year, with a phased commercial rollout in epilepsy centres to show the system’s clinical utility.
Minder provides continuous tracking of the brain’s electrographic activity, offering epileptic individuals and their physicians comprehensive insights into the brain’s activity over prolonged durations.
It can be utilised by patients during their usual daily routines.
By facilitating long-term monitoring of individuals in everyday settings rather than in a clinical setting, the device supplies data that aids in enhancing the comprehension and treatment of underlying health issues. This includes evaluating drug therapeutic effectiveness and exploring other treatment options.
Epilepsy is said to be a neurological disorder marked by repeated seizures due to the brain’s abnormal electrical activity.
Epiminder CEO Rohan Hoare said: “By extending the monitoring window of an EEG from days using current technologies to months or even years with Minder, we can deliver unprecedented access to a high-fidelity stream of continuous EEG data to healthcare professionals and their patients.
“As the first and only implantable continuous EEG monitor approved in the US, Minder can provide healthcare professionals and their patients with more accurate and timely diagnoses, enhanced therapeutic drug monitoring, and can better inform decisions on non-drug treatments like surgery.”
