FDA OKs Neuroimaging Tool to Aid Diagnosis of Degenerative Brain Diseases
The US Food and Drug Administration (FDA) has cleared NM-101 (Terran Biosciences), a cloud-based software platform to analyze neuromelanin-sensitive MRI scans, which could aid in the diagnosis of neurodegenerative diseases.
Research has suggested that neuromelanin is a potential biomarker for neurologic disorders such as Parkinson's disease (PD).
A recent meta-analysis of 12 neuromelanin MRI studies with 403 patients with PD and 298 control participants found that neuromelanin MRI had "favorable" diagnostic performance in discriminating PD patients from healthy controls.
"It's great to see neuromelanin MRI become more accessible in clinical settings. We hope this opens the door for the adoption of neuromelanin MRI into the clinical workflow for patients with neuropsychiatric disorders," added Guillermo Horga, MD, PhD, associate professor of psychiatry at Columbia University Vagelos College of Physicians and Surgeons.
Source: MEDspace