Latest news with #Epiminder
Yahoo
19 hours ago
- Health
- Yahoo
Epiminder reports trial outcomes of implantable EEG monitoring device
Epiminder has reported the outcomes from the landmark UMPIRE (sub-scalp monitoring epileptic seizures) trial evaluating Minder, an implantable continuous electroencephalogram (EEG) monitoring system (iCEM). The platform has been validated for its safety and efficacy in capturing high-quality EEG data over extended durations. The trial, which took place across hospitals in Australia, has shown that the Minder system's performance is comparable to the current standard of care scalp-based EEG monitors. Minder has been recognised as a breakthrough device and recently authorised by the US Food and Drug Administration (FDA) through the de novo classification. Key findings from the trial include the safety of the Minder system, without any serious adverse events related to the device or procedure. The EEG signal clarity was found to be on par with the standard 10-20 scalp-based recordings. Clinically relevant outcomes were also observed in 88% of subjects with drug-resistant epilepsy, including those with frequent unreported seizures. Minder's bilateral recording feature demonstrated clinically significant observations that were not detectable with unilateral recordings in 23% of the subjects. Epiminder's chief medical officer and founder Mark Cook said: "The UMPIRE results exceeded our expectations, proving that continuous EEG monitoring over years, not just days, is not only possible but transformative for epilepsy management.' According to the company, this minimally invasive device is tailored for continuous monitoring of the brain's electrographic activity. It enables individuals to be monitored while they engage in their daily activities, providing data for understanding epilepsy and effective treatment alternatives. Implanted under the scalp, the EEG recording and transmitting device is prescribed for use in those aged 18-75 years with drug-resistant epilepsy who cannot use or are not indicated or tolerant of more conservative monitoring tools. It assists physicians in remotely assessing and monitoring patients' conditions, with EEG data available for healthcare providers at various locations from where the data is gathered. "Epiminder reports trial outcomes of implantable EEG monitoring device" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Se produjo un error al recuperar la información Inicia sesión para acceder a tu portafolio Se produjo un error al recuperar la información Se produjo un error al recuperar la información Se produjo un error al recuperar la información Se produjo un error al recuperar la información
Business Wire
2 days ago
- Health
- Business Wire
Epiminder Announces Publication of Landmark Clinical Trial Confirming Safety and Efficacy of the Minder® System
MELBOURNE, Australia & DALLAS--(BUSINESS WIRE)-- Epiminder, a pioneer in implantable continuous EEG monitoring (iCEM™), today announced the publication of results from its landmark UMPIRE (sUb-scalp Monitoring ePileptic seIzuREs) clinical trial in Epilepsia validating the safety and efficacy of its iCEM. The study, conducted across leading Australian hospitals, demonstrated Minder's ability to capture high-quality EEG data for extended periods that are comparable to current standard of care scalp-based EEG monitors. The Minder system is a designated Breakthrough Device and has recently been granted clearance for marketing in the United States by the FDA. A world record five-year continuous EEG recording has recently been reported by Epiminder using the system. 'The UMPIRE results exceeded our expectations, proving that continuous EEG monitoring over years—not just days—is not only possible but transformative for epilepsy management,' said Professor Mark Cook, Epiminder's Founder and Chief Medical Officer. Key Highlights of UMPIRE Clinical Trial: The Minder system was found to be safe, with no device or procedure related Serious Adverse Events EEG signal clarity was comparable to standard of care 10-20 scalp-based recordings Clinically relevant findings were identified in 88% of drug-resistant epilepsy patients, including patients with frequent unreported seizures Minder's unique bilateral recording capability revealed clinically relevant findings not possible with unilateral recordings in 23% of patients Commercial Outlook: Rohan Hoare, Epiminder's CEO, said, 'We are very pleased with the positive impact that Minder can have on the lives of people with epilepsy. Following the FDA authorization in April 2025, Epiminder will initiate a phased U.S. launch in Q3 2025, targeting major epilepsy centers.' Please visit Epilepsia for open access to the UMPIRE publication. Follow Epiminder on LinkedIn and explore for more information. About Minder Minder is a minimally invasive device for continuous monitoring of electrographic activity of the brain, providing epilepsy patients and their doctors with detailed data on brain activity over an extended period. Patients can wear the device as they go about their normal daily activities. Minder's long-term monitoring of patients outside of a controlled clinical environment provides data needed for better understanding and more effective treatment of underlying conditions, including determining the effectiveness of drug therapies and other potential interventions. About Epiminder Founded in 2017 by Professor Mark Cook together with the Bionics Institute, St Vincent's Hospital, the University of Melbourne and Cochlear Limited, Epiminder is a medical device and information solutions company focused on developing diagnostic and treatment tools for epilepsy and other seizure disorders where continuous monitoring is required. Epiminder is headquartered in Melbourne, Australia and has offices in the United States.
