FDA clearance

FDA OKs Phase 2 clinical trial of KYV-101 for progressive MS

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…

FDA clears BrainSpec’s tool to measure metabolites on brain scans

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)…

FDA clears AI tool for detecting disease activity on MRI scans

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…

FDA Clears Leg-worn ‘Neural Sleeve’ to Aid Walking

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…