Medtronic plc said it secured U.S. FDA approval for its first closed-loop spinal cord stimulator (SCS), designed to take in signals from the body and adjust its therapy automatically.
Epitel Inc. received U.S. FDA clearances for two epilepsy-focused technologies that simplify detection and analysis of seizures in patients with suspected epilepsy. The Remi remote electroencephalogram monitoring system is a wearable device that allows patients to continue with their daily activities for extended periods without the restrictions of wires, while still capturing intermittent seizures. The Remi Vigilenz artificial intelligence system uses machine learning to identify and note seizure events in the Remi EEG records.
In what represents its first patenting, PBSF Inc. filed for protection of brain monitoring and neuroprotection strategies for infants at high risk on a large scale.
Lund, Sweden based-Paindrainer AB received notification from the European Patent Office that it intends to grant this patent application for its digital tool, Paindrainer, which coaches users in managing their pain and provides guidance on how to reach a personalized activity balance to reach an optimal functional level and alleviate pain.
Singapore- and U.S.-based Sunbird Bio Pte Ltd. is advancing its blood-based diagnostics platform for neurological diseases like Alzheimer’s and Parkison’s disease (AD/PD), amidst new breakthroughs in the AD drug therapies and diagnostics space.
Hyperfine Inc. aims to simplify monitoring of potentially dangerous adverse events associated with amyloid-targeting therapies with the launch of its Capturing ARIA Risk Equitably with Portable MR observational study. The study will evaluate the benefits of the Swoop portable brain MRI system in acquiring images needed to detect amyloid-related imaging abnormalities in Alzheimer’s patients as specified in product labeling.
South Korean med-tech companies Nunaps Co. Ltd. and Share & Service are the latest to clear domestic approvals for digital therapeutics as the government ramps up R&D funding for artificial intelligence-based medical technologies.
Neurovalens Ltd recently received U.S. FDA clearance for its Modius Stress device, a neurostimulator that treats people suffering from generalized anxiety disorder (GAD). It also closed a £2.1 million (US$2.65 million) funding round and is planning to raise up to $50 million in a series B fundraising round to be launched later this year.
Quest Diagnostics Inc. expanded its Alzheimer’s disease (AD) portfolio with a blood-based biomarker test for phosphorylated tau 217 (pTau217). The test joins the company’s plasma tests for p-tau181, beta-amyloid 42/40 ratio and ApoE genetic risk as well as several cerebrospinal fluid tests for Alzheimer’s.
Brain Trust Bio Inc. (BTB) will soon begin phase I trials in Australia of its IT-Riluzole delivered to the brain via a continuous intrathecal drug delivery method in people with amyotrophic lateral sclerosis. The company’s concept is to take known drugs that work and make them better by delivering them exclusively to where patients need them most, BTB co-founder and CEO Chen Benkler told BioWorld.