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.

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.

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.

Abbott Laboratories has seen the launch of the IonicRF Generator, which delivers a nonsurgical, minimally invasive treatment for the management of pain in the nervous system. The generator is a radiofrequency (RF) ablation device that uses heat to target specific nerves and block pain signals from reaching the brain. The launch of Abbott's IonicRF Generator looks to help the estimated 50 million people in the U.S. currently living with chronic pain.

The U.S. FDA has given its nod to a new solution that aims to help with the temporary reduction of sleep disturbance related to nightmares in certain people. Specifically, the agency reviewed the device, from Minneapolis-based Nightware Inc., through the de novo premarket review pathway and now is permitting its use in patients aged 22 years of age or older who are suffering from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD). The agency previously granted the solution breakthrough device designation.

PARIS – Oncomfort SA has entered a partnership with Vygon SA for distribution of its Sedakit in six countries in Europe. The synergy between Vygon’s specialization and Oncomfort’s fields of application aims to enable greater acceleration of the adoption of Digital Sedation by health care professionals and patients. “Thanks to this strategic partnership, our new technology for relieving patient pain and anxiety without medication is going to be widely available in Europe,” Mario Huyghe, CEO of Oncomfort, told BioWorld.