FDA authorises Epiminder medical device for epilepsy developed in collaboration with the Bionics Institute
We are proud to share that Epiminder’s Minder® device for epilepsy, pioneered by world-renowned neurologist Professor Mark Cook and developed in collaboration with the Bionics Institute, Cochlear Ltd, the University of Melbourne and St Vincent’s Hospital, has reached the major milestone of FDA authorisation.
The US FDA has granted authorisation for Minder® under its De Novo pathway creating a new classification of device, allowing for marketing and sale of the device in the US for patients with drug resistant epilepsy.
Minder® is an implantable device for continuous monitoring of brain activity brain developed to address one of the most persistent challenges in epilepsy care: the lack of accurate, long-term data on seizure activity.
Rohan Hoare CEO of Epiminder, founded in 2017 and headquartered in Melbourne with offices in the US, says that by extending the monitoring window of an EEG from days using current technologies to months or even years with Minder, can deliver unprecedented access to a high-fidelity stream of continuous EEG data to health care professionals and their patients.
He said: “The FDA’s clearance of Minder is a significant milestone for Epiminder and more importantly for the 52 million people around the world who have epilepsy.
“As the first and only implantable continuous EEG monitor approved in US, Minder can provide health care 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.
“Looking ahead, Epiminder plans to develop a suite of integrated software solutions that will extend the clinical impact of the Minder device, for example by providing patients with advance notice of seizures through AI-enabled forecasting.”
Epiminder intends to formally launch Minder® in the US during H2 2025 undertaking a phased commercial roll out into leading epilepsy centres as part of a program to demonstrate the clinical utility of the system.
You can read more about the device on the Epiminder website: https://epiminder.com/minder-system
