Neuronaute® Plus, BioSerenity’s comprehensive simplified EEG device, has received FDA clearance

November 30, 2023

Paris, FRANCE, Boston, MA, USA

BioSerenity, a leader in EEG Technology announces the FDA Clearance of Neuronaute® Plus. A device opening up new possibilities for EEG Recordings.

Neuronaute® Plus is a small portable medical device collecting data that loads into the cloud to enable any specialist in Europe, in Canada and in the US to analyze EEG recordings. It is so easy to use, that very little training is needed. Combined with the ease of use and simplicity of the Icecap®, an innovative EEG electrode net, the Neuronaute® Plus is helping healthcare professionals perform EEG recordings and monitoring in a cost-effective way.

According to Dr. Bruce Lavin, Chief Medical Officer: “BioSerenity’s Neuronaute® solution is addressing a particularly strong medical need by allowing convenient diagnoses of epilepsy and other significant brain disorders with minimal technologic support . We are excited to offer an important solution that will benefit patients and assist Hospitals and Neurologists in providing greater EEG accessibility for over 3.5 million people living with Epilepsy in the US”.

Vincent Marcel, CEO added: “Getting the right technology to diagnose and training staff can be real challenges. We are very proud to bring enhanced innovation to make EEG more accessible for doctors and patients and to allow doctors to go even further to patients’ life. With the strong support of Jolt Capital, we look forward bringring worldwide more personalized, preventive and costeffective medicine for neurological in the US and other geographies. »

The Neuronaute® Plus is the size of a smartphone, communicates wirelessly, allows for a seamless battery change for extended recordings without interruptions, allows for live monitoring with or without video and is compatible with both traditonal EEG cup electrodes or the Icecap®, a fast and convenient disposable electrode system that reduces time of installation by up to 50%*.

Launched in Europe in the summer, the Neuronaute® Plus has already started to open up new opportunities to address epilepsy diagnoses. Its convenience has allowed doctors to explore new use cases such as using the Neuronaute® in remote areas, in the Operating Room, in the Intensive Care Unit or for long term home monitoring but also in Pediatric Monitoring in each geography.

Following the FDA Clearance, the Neuronaute® Plus will be launched in the US Market at the AES Conference in Orlando, Florida on December 1st, 2023 and will be made available to hospitals and doctors all over the country. Come see us at our AES Booth #223.

*Based on Internal study

About Bioserenity
Founded in 2014 and headquartered in Paris, France, and Boston, MA, USA, BioSerenity is
an innovative Medical Technology company focused on Healthcare as a Service, IoMT, A.I.
and Real World Evidence in Neurology, Sleep, Cardiology. The company is the recipient of
many awards in Business and Medicine. The company has deployed solutions such as the
Neuronaute®, a long term ambulatory EEG solution and LR, software solutions to help
doctors provide care to patients as efficiently as possible, anytime, anywhere.

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André Pitié