FDA clears upgraded software to aid MRI analysis in MS

The U.S. Food and Drug Administration (FDA) has cleared an extended version of Neurophet Aqua, an MRI analysis software that uses artificial intelligence (AI) to measure disease-related changes in brain scans. Earlier clearance enabled Neurophet‘s software to analyze brain atrophy using T1-weighed MRI scans in people with neurodegenerative conditions.

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…

CPT code issued for MRI brain scan software by Icometrix

Icometrix‘s quantification software for brain MRI scans has received a Current Procedural Terminology (CPT) III code, a temporary code for emerging technologies that should facilitate reimbursement. CPT codes, issued by the American Medical Association, are designed to identify procedures and services in healthcare plans. They are used in the…