FDA clears neuromelanin MRI analysis platform for evaluating neurological disorders

Key takeaways:

• Neuromelanin analysis is an emerging adjunct in evaluation of Parkinson’s disease and other disorders.
• NM-101 is the first platform for analyzing neuromelanin MRI cleared by the FDA.

The FDA has cleared for marketing “the world’s first” cloud-based software for clinical analysis of neuromelanin-sensitive MRI scans, according to a press release from the manufacturer.

Terran Biosciences cited studies indicating that neuromelanin MRI can be a useful adjunct in evaluating Parkinson’s disease, as well as Alzheimer’s disease and schizophrenia. The process using the cloud-based platform NM-101 is cheaper, quicker and less invasive than DaT-SPECT, a current adjunctive imaging technique, according to the release.

“We were excited to partner with leading researchers in the field and conduct the key development steps necessary to bring it through to FDA clearance,” Terran founder and CEO Sam Clark, MD, PhD, said in the release. “We believe this technology could become very important in the clinical workflow of patients with neurological and psychiatric disorders.”

Neuromelanin MRI images can be sent to Terran using NM-101 through a hospital’s picture archiving and communication system, with a full report coming back in less than an hour. Algorithms fully automate the analysis and cross-scanner harmonization, and the platform can “seamlessly integrate” into hospital and imaging center workflows, according to the release.

“The research suggests that neuromelanin MRI is a promising approach with the potential to become part of the standard of care for the workup of all patients suspected of Parkinson’s and related diseases,” David Sulzer, PhD, a neurobiology professor at Columbia University, said in the release.