The Australian-developed Minder system is an implantable device for continuous monitoring of brain activity in patients with epilepsy, developed to address the shortcomings in current electroencephalogram technologies The 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 Epiminder intends to launch Minder in the US during H2 2025 MELBOURNE, Australia and DALLAS, April 23, 2025 /PRNewswire/ -- Epiminder, a pioneering medical device and information solutions company, today announced that it has been granted FDA authorisation via the De Novo classification for Minder, its proprietary implantable continuous electroencephalogram monitoring system (iCEMTM) for patients with epilepsy. Minder has also been designated as a Breakthrough Technology by the FDA, recognising its potential to provide more effective diagnosis and management for people living with epilepsy. This De Novo authorization is significant as it creates a new classification of device which underscores both the innovation and the clinical validation behind Minder.