Today (1/5) BioSerenity announced that the U.S. Food and Drug Administration (FDA) cleared the Neuronaute® EEG System and IceCap® EEG wearable device. The device is designated for patients diagnosed with epilepsy, and will enable physicians to remotely monitor and assess the electrical brain activity of patients wearing the device. BioSerenity Chief Medical Officer, Bruce Lavin, MD, MPH, stated, “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.”
Read more here.
More on: News Regulatory