Positrigo AG is raising $10 million for production and commercialization of its Neurolf brain positron emission tomography system in the U.S. The system hepls to diagnose Alzheimer’s disease. With drugs such as Leqembi and Kisunla gaining U.S. FDA approval to treat the devastating neurological condition, the company is seeing increasing demand for its system, Neurolf CEO and co-founder Jannis Fischer, told BioWorld.
Beacon Biosignals Inc. can rest easy now that it has received U.S. FDA authorization of its predetermined change control plan for the Dreem 3s, a wearable sleep monitor that conducts electroencephalograms as users sleep. The authorization allows Beacon to incorporate updates to the Dreem 3S sleep-staging algorithm acquired through machine learning without submitting a new 510(k) application.
An artificial intelligence-powered contactless monitoring device developed by Albus Health Ltd. can detect signs of asthma attacks in children up to five days before they occur.
