NEWS AND MEDIAS
- BY :
- Press release
BioSerenity Announces FDA Clearance for EEG Wearable Device System
Neuronaute® EEG System and IceCap® bring Comprehensive Remote Electroencephalography Monitoring Services to People Living with Neurological Disorders
PARIS and ATLANTA, Jan. 5, 2021 /PRNewswire/ — BioSerenity, Inc., a leading global provider of remote diagnostic solutions in the areas of Neurology, Cardiology and Sleep Disorders announced today it received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Neuronaute® EEG System and IceCap® EEG wearable device that will allow physicians to remotely monitor and assess electrical brain activity of people living with epilepsy.
One in 26 people will develop epilepsy or recurrent seizures during their lifetime. Due to the complexity of providing long term testing, many patients have limited access to care. Together, the IceCap® and Neuronaute® system are a unique and ideal combination to facilitate access to care in a variety of settings including rural and remote environments.
The Neuronaute® system assists healthcare professionals in the diagnosis, monitoring and assessment of epilepsy and other neurological disorders in adult patients. The Neuronaute® system consists of hardware and software that acquires, displays, stores, archives, and transmits EEG signals from the brain using a full 10-20 montage. Remote access is facilitated via the Neuronaute® N-CLOUD which receives EEG signals from the Neuronaute® Head Module which then transmits to the cloud. This proprietary design enables physician review and interpretation at an office, hospital, or other remote location.
The IceCap® (Immediate Care Encephalography) Cap is a wearable medical device used together with the Neuronaute® system. It is a single-use disposable electrode cap that quickly and easily enables the recording of short interval (less than 1 hour) EEG for routine or emergency brain activity assessments.
“BioSerenity is committed to improving patient care by making EEG diagnostics more readily available to the 3.4 million people in the USA alone who are living with epilepsy,” according to BioSerenity Chief Medical Officer Bruce Lavin, MD, MPH. “With FDA clearance to market the Neuronaute® system and IceCap®, we can deliver high-quality, cost-effective diagnostic care by remotely connecting patients in need with neurological specialists anytime and anywhere.” Pierre-Yves Frouin, BioSerenity CEO adds, “This is an exciting milestone for BioSerenity and demonstrates our commitment to bring world class medical devices and technological solutions to the market.”
About BioSerenity, Inc.
Headquartered in Paris, France and Atlanta, GA, USA, BioSerenity is an innovative medical technology company focused on Healthcare as a Service, IoMT, A.I. and real-world evidence in Neurology, Sleep Medicine, and Cardiology. BioSerenity provides remote diagnostic solutions to healthcare providers and patients in the US, Europe and Caribbean. BioSerenity is also the preferred provider for several Contract Research Organizations and prominent university medical facilities across the US, France, and other parts of the world. For more information, please visit us.bioserenity.com.
Using artificial intelligence for precision sleep medicine
According to Cathy Goldstein, MD, MS, associate professor of neurology at the University of Michigan Sleep Disorders Center, data gathered during sleep examination and interpreted by AI could predict the onset of diseases even before the first appearance of symptoms.
Indeed, a polysomnography is complete and in-depth sleep examination allowing the recording of several variables (cardiac, cerebral, muscular, ocular, and respiratory activity) thanks to sensors and electrodes placed on the body. The interpretation of those big amount of data collected during a night of sleep by AI could predict who is going to get dementia in the future, thanks to specific patterns identified in the data.
For instance, observing a change in heart rate variability could signal the onset of pneumonia, which if identified upfront could be considered and prevented by treating physician.
Indeed, there’s already evidence that certain subtypes in obstructive sleep apnea (OSA) are predictive of cardiovascular events. But thanks to AI and its in-depth analysis, new important data could be identified allowing physician to select the right treatment for the right patient at the right time. As opposed to where we stand today, according to Alyssa Cairns, PhD, head of sleep research at SleepMed BioSerenity, with a data interpretation done by a sleep technician that looks at each 30-second window of the patient’s sleep, taking time and introducing human bias. Moreover, the sleep tec interpretation does not allow for an in-depth analysis as those that could be reach thanks to AI. Hence, why sleeps researchers and innovators are working actively on how polysomnography examination is interpreted, in order to improve sleep care and maybe care beyond sleep.
To know more, read the full article on Sleep Review: https://www.sleepreviewmag.com/sleep-diagnostics/connected-care/ai-machine-learning/artificial-intelligence-sleep-medicine-new-population-health-insights/
- United States
Virtual clinics for epilepsy care?
Bridging the healthcare gap: Building the case for epilepsy virtual clinics in the current healthcare environment
In this article published in “Epilepsy & Behavior” journal, authors question themselves about access to healthcare: how can we facilitate access to quality care in a healthcare environment transformed by the pandemic? Difficulties in care continuity have emerged for patients suffering from serious chronic disorders, who usually require regular visits to their specialist.
To support a healthcare system greatly impacted by the pandemic, authors investigate virtual clinics and telehealth services to optimize care for these patients.
The article takes the situation of epileptic patients, who do not have enough specialist available close to their home. An absence that can be explained by the disease’s diagnostic test of reference, the electroencephalogram (EEG). A test that remains poorly recognized outside epilepsy. During this period, the lack of availability of specialists has also emerged as an issue.
These barriers to continued quality care can be overcomed by the introduction of virtual clinics. Clinics that would place the technologies directly in patients’ homes or at local clinics near the patients’ homes. This way, patients could benefit from specialists that provide quality care, anywhere in the world, at any time of the day.
- Press release
Report of EEG Finding on Critically ill Patients with COVID‐19
Paris & Atlanta, June 15th 2020 – BioSerenity publishes in the Annals of Neurology its discovery on critically ill patients with COVID-19. The discovery made while interpretation EEG for COVID-19 patients warns healthcare professionals about the need of performing an EEG in COVID-19 patients presenting neurological disorders.
BioSerenity, partner of the APHP (French Parisian hospital) for the performing and interpretation of EEG exam with its service Neurophy, has been contacted several time in the begining of the surge of the COVID-19 pandemic to perform EEG on ICU patients.
The EEGs prescribed on patients showing altered mental status, delayed awakening, or poor arousal, has allowed to highlight central nervous system disorders linked to COVID-19
The characteristic EEG anomalies observed by Neurophy’s interpreting doctors has allowed to match them to the neuro invasiveness of COVID-19.
The neurological impact of COVID-19: Interview of Pr. Vespignani
19th of April, professor Hervé Vespignani, BioSerenity’s French medical director was interviewed on French live television and radio to talk about neurological consequences observed in COVID-19 patients. In the interview, the professor speaks about the recent discovery made by Neurophy’s team of EEG irregularities in some COVID-19 patients.
These abnormalities, which are characteristics of an encephalitis, show the virus’ impact the cerebral cortex through an inflammatory mechanism. The professor on the behalf of his team, warns the medical population, through these interviews and a coming publication, to stay alert for potential neurological manifestations in COVID-19 patients. He even recommends the systematization of EEG exploration for patients in reanimation that experienced a delay in waking-up from the induced coma, for the more severe patients that required respiratory support.
Indeed, this delay, if not explained by complications linked to the sedation could be explained by the inflammation. Hence the importance of performing an EEG as soon as possible to avoid any neurological consequences due to the delay in diagnosing the encephalitis.
BNP Paris and CA Champagne Bourgogne sign a syndicate loan with Bioserenity.
"Made in France" exhibition, BioSerenity at the Elysée Palace
Paris, January 18th, 2020 – BioSerenity exhibited a prototype of a connected textile, suitable for a pediatric use, at the “Made in France” exhibition, held at the Elysée Palace in Paris this weekend.
BioSerenity’s medical devices are developed and manufactured in France, in Rosières-prés-Troyes factory, capitalizing on a territorial know-how in textile. At the crossroads of digital and medical innovation, BioSerenity offers connected medical devices, providing continuous and long-term recording at the patient’s home or at the hospital, to help healthcare professionals to diagnose and support their patients.
BioSerenity attended the French Congress of Psychiatry
Nice, december 4th 2019 – BioSerenity and its medical subsidiary company attended the French Congress of Psychiatry in Nice, between the 4th and 7th december 2019.
During this event, the interest of alectrophysiology in psychiatry was highlighted during a workshop moderated by Prof. Schwan (Nancy) in presense of Dr. Micoulaud-Franchi (Bordeaux), Pr. Vespignani (Nancy ) and Dr. Schwitzer (Nancy). In particular, during this conference, the importance of electrophysiological monitoring (EEG, PSG and ERG) in psychiatry was emphasized.
More particularly, according to the speakers, the evaluation of the EEG as part of the patient journey in psychiatry should be used as a bioelectric marker of pathologies treatable by non-psychiatric therapeutics, but also as a bioelectric marker of the response and tolerance to treatments, particularly in narrow margin specialized therapies. In addition, EEG could be used as a bioelectric marker in a psychophysiological perspective to consider personalized neuro-modulatory therapies.
Also, psychiatric comorbidities and sleep have been highlighted as well as the importance of investigating the patients’ sleep quality in a systematic way in the care pathways in psychiatry.
Finally, the ERG was recognized by stakeholders as a tool for evaluation and prediction of the response to psychiatric treatment and its use could be relevent in clinical practice for the differential diagnosis between unipolar depression and bipolar depression.
Paris, November 22nd – The 12th of December 2019 will be held the Day of Action on Atrial Fibrillation. The Atrial Fibrillation is characterized by an irregular heart rate among other characteristics.
BioSerenity supports this testing and awareness day organized by Action Coeur. Coordinated by the professor Gilles Montalescot, cardiologist within the Cardiolgy Institute of La Pitié Salpêtrière hospital, Action Cœur is an independent academic not for profit Academic Research Organization, acting and promoting clinical research and prevention in the field of cardiovascular diseases.
Join Action Coeur on the 12th of December from 9:00 am to 5:00 pm at the Cardiolgy Institute of La Pitié Salpêtrière hospital to be informed on atrial fibrillation.
Venez vous informer à l’Institut de Cardiologie à l’Hôpital de la Pitié Salpêtrière le 12 décembre 2019 entre 9h et 17h.
Symposium: Health data and collective intelligence
Paris, November 18th – Over the last few years, the AI has invited itself within our everyday lives to improve them. Continuing this trend, the result will may be the change of the health system as we know it today.
In this environment, the BioSerenity team attended to the “Health Data and Collective Intelligence” conference during which the future use of the health data was introduced by the State representatives and health players.