FDA clearance

The U.S. Food and Drug Administration (FDA) has cleared a Phase 2 clinical trial to test Kyverna Therapeutics‘ cell-based therapy candidate KYV-101 in people with treatment-resistant progressive multiple sclerosis (MS). Called KYSA-7 (NCT06138132), the open-label trial will enroll an estimated 12 patients with either primary progressive…

The U.S. Food and Drug Administration (FDA) has cleared BrainSpec Core, a platform that performs non-invasive measurements of brain chemistry, for use in diagnosing some of the most common diseases that affect the brain, including multiple sclerosis (MS). Developed by BrainSpec, the platform uses magnetic resonance spectroscopy (MRS)…

Pixyl.Neuro, a next-generation software that uses artificial intelligence (AI) in analyzing MRI scans to help detect and monitor multiple sclerosis (MS) disease activity, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for clinical use. 510(k) clearance is required for medical devices used in the…

Cionic has received authorization from the U.S. Food and Drug Administration (FDA) to market its lightweight, leg-worn Neural Sleeve to improve walking in people with multiple sclerosis (MS) and other conditions that affect mobility. The decision comes four months after the company submitted the device — the first to…

Emerald Health Pharmaceuticals will soon begin enrollment in a Phase 2a clinical trial investigating its cannabidiol-derived therapy EHP-101 in relapsing forms of multiple sclerosis (MS). The trial (NCT04909502) aims to recruit 50 patients, ages 18-55, with relapsing-remitting MS (RRMS) and active secondary progressive MS (SPMS).

The U.S. Food and Drug Administration (FDA) has authorized the use of Bioness’ L300 Go System electrical-stimulation rehabilitation device for multiple sclerosis (MS) patients and others with walking impairment. It is the first electrical stimulation device to offer 3D motion detection of gait and muscle activation, the company says. The L300…