Using in vivo imaging technology, investigators at the University of Utah and the University of Padua have identified a new signaling mechanism for glutamate that was linked to the onset of spreading depression or spreading depolarization, a neuronal activity pattern that plays a role in multiple neurological disease states. In mouse models of migraine, glutamate, which is the major excitatory neurotransmitter of the brain, was released in what the authors called "plumes" or puffs.

The U.S. FDA has granted breakthrough device designation to Spark Biomedical Inc. for its Roo system, a transcutaneous electrical nerve stimulator to assist newborns with opioid withdrawal. The noninvasive neurostimulation device is modeled on the company’s Sparrow Therapy System for adult opioid withdrawal relief.

PARIS – Braintale SAS has completed a $1.2 million seed round towards its portfolio of digital quantification and prediction medical devices for neurology and intensive care. This funding round, including a loan from Bpifrance, attracted investment from business angels, as well as industry and health care professionals.

PERTH, Australia – Med-tech company Control Bionics began trading on the Australian Securities Exchange (ASX:CBL) Dec. 7 in an IPO that saw the company raise AU$15 million (US$11.25 million). Melbourne-headquartered Control Bionics develops assistive technologies (AT) that allow people with severe disabilities to communicate and control electronic devices using electromyography (EMG).

A percutaneous hydrogel treatment for chronic low back pain has won a U.S. FDA breakthrough device designation. The status will enhance interactions between Baltimore, Md.-based Regeltec Inc. and the agency during regulatory review of the Hydrafil implant, accelerating the path to clinical trials and commercialization.

PARIS – Lucine Therapeutics SAS has raised $6.6 million to finance development of its first digital therapy aimed at relieving chronic pain. A 100% French initial funding round, six French funds have contributed to this seed fund.

For the 795,000 Americans who suffer a stroke each year, time is brain. The U.S. FDA granted 510(k) clearance to a solution the developer says could cut time-to-treatment in stroke by an hour, preserving 3.6 years of healthy life. Nico.lab’s artificial intelligence-based CT scan analyzer, Strokeviewer LVO, uses an algorithm that enables faster triaging of stroke patients and enables physicians to see the location of occlusions in minutes.

Recent advances in biomarkers and imaging capabilities have improved the diagnosis of Alzheimer’s disease (AD). Fujirebio Diagnostics Inc. aims to further expand the arsenal of AD diagnostics with its Lumipulse G β-Amyloid Ratio (1-42/1-40) in vitro diagnostic test. On Wednesday, the company said it had filed a 510(k) submission with the U.S. FDA for premarket clearance of the Lumipulse G β-Amyloid IVD.