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.
Keeping you up to date on recent developments in neurology, including: AI developed to predict psychiatric diagnoses from Facebook activity; AIR coil from GE Healthcare shows promise for whole-brain imaging; Big data analysis suggests role of brain connectivity in epilepsy-related atrophy; Gestational age linked to ADHD in children with Down syndrome.
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.
Keeping you up to date on recent developments in neurology, including: Wireless chip developed to improve brain research; Diabetes increases damage around amyloid plaques in Alzheimer’s; Smartphone keystrokes show promise in monitoring progression of MS.
TORONTO – A Canadian plant-based, cellulose scaffold implant for regenerating healthy spinal cord tissue has received U.S. FDA breakthrough device designation. The designation will enhance the process by which Ottawa-based Spiderwort Inc. interacts with the FDA during regulatory review of the Cellubridge implant, said Spiderwort CSO and cofounder Andrew Pelling, speeding its way to clinical trials.
Keeping you up to date on recent developments in neurology, including: Individualized brain stimulation therapy improves aphasia in stroke survivors; Weekly physical activity may help prevent Alzheimer’s in people with mild cognitive impairment; Diagnosing Parkinson’s via mitochondria interaction networks.
Researchers at the Feinstein Institutes for Medical Research, the research arm of New York-based Northwell Health, illuminated the precise pathway from the brainstem to the spleen that controls inflammation in a study published in the Proceedings of the National Academy of Sciences of the United States of America (PNAS). Essentially, the work demonstrates how scientists could use the vagus nerve to hack the immune system, enabling them to turn down the excessive response that underlies autoimmune disease without the use of biologics or immunosuppressive drugs.
Phagenesis Ltd. reported real-world data showing its Phagenyx system provides significant benefits in the treatment of patients with dysphagia, or difficulty swallowing, due to a variety of causes.
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