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.

Researchers from the U.K. reported seeking protection for a device and method that combines electromyography (EMG) and Raman spectroscopy to improve the diagnostic pathway for patients with neuromuscular disorders, and that may be used as a minimally invasive bedside test of muscle health.

In what represents its first patenting, Alva Health Inc. has been granted protection for a method for detecting stroke from falls using a combination of wearable motion sensors and artificial intelligence.

Laboratory Corp. of America Holdings introduced a glial fibrillary acidic protein blood-based test available commercially in the U.S. for the early detection of neurodegenerative diseases and brain injuries. The test, which the company said was the first of its kind, is designed to assess the presence and progression of Alzheimer’s disease, multiple sclerosis, glioblastoma and traumatic brain injury.

Finding an effective medication for patients with major depressive disorder is notoriously difficult, with 70% of patients failing to respond to the first drug prescribed and 30% not responding to the first four medications. Complicating matters, genetic mutations can increase psychotropic drug-related adverse events, including hospitalizations. A recent study indicates Myriad Genetics Inc.’s Genesight test can help minimize the risk of these negative events, with a reduction of nearly 40% in psychiatric-related hospitalizations and prescription of medications with significant gene-drug interactions.

After decades of trying and dozens of failed trials, amyloid targeting has paid off with the first disease-modifying agents reaching the market. But success does not mean slam dunk. Aduhelm (aducanumab, Biogen Inc.) was dogged by controversy throughout its brief tenure, and Biogen pulled the plug on it in early 2024. Leqembi (lecanemab, Biogen Inc.) has received full approval. In this second installment of a three-part series on Alzheimer’s, BioWorld looks at the nuanced view of amyloid’s role in the disease.