FDA Clears Emerging Brain PET System

The Food and Drug Administration (FDA) has granted 510(k) clearance for the NeuroLF system, which offers dedicated positron emission tomography (PET) imaging of the brain.

In light of the recent FDA approval of another disease-modifying therapy (Kisunla, Lilly) for Alzheimer’s disease, which reportedly accounts for approximately 70 percent of dementia cases for patients over 60 years of age, the FDA clearance of the NeuroLF system for monitoring and detection of neurological conditions is particularly timely, according to Positrigo, the developer of the NeuroLF device.

Positrigo noted the PET imaging system also facilitates diagnosis of brain tumors, epilepsy, and neurodegenerative conditions such as Parkinson’s disease.

While other PET systems involve bulky devices with significant maintenance costs, Positrigo emphasized the compact design of the NeuroLF system, which allows functional point-of-care brain PET scans with patients in a seated position.

"It is not the first device of its kind which receives market clearance in the (United States) but we believe that our patient-centric and customer-driven design and development efforts over the last couple of years brought us into the pole position to offer the best imaging solution to address the increased demand of brain PET scans," noted Jannis Fischer, Ph.D., the co-founder and CEO of Positrigo.