FDA Clears Emerging Brain PET System
Offering dedicated PET imaging of the brain, the compact NeuroLF system may facilitate patient comfort while enabling detection and monitoring of brain tumors, epilepsy, and neurodegenerative diseases such as Alzheimer’s disease.
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.
The newly FDA-cleared NeuroLF PET imaging system, which enables detection and monitoring of conditions ranging from epilepsy to Alzheimer's disease, offers a compact design that facilitates patient comfort, according to Postrigo, the developer of the device. (Image courtesy of Positrigo.)
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.
The Reading Room Podcast: Current Perspectives on the Updated Appropriate Use Criteria for Brain PET
March 18th 2025In a new podcast, Satoshi Minoshima, M.D., Ph.D., and James Williams, Ph.D., share their insights on the recently updated appropriate use criteria for amyloid PET and tau PET in patients with mild cognitive impairment.
How to Successfully Launch a CCTA Program at Your Hospital or Practice
June 11th 2025Emphasizing increasing recognition of the capability of coronary computed tomography angiography (CCTA) for the evaluation of acute and stable chest pain, this author defuses common misperceptions and reviews key considerations for implementation of a CCTA program.
Possible Real-Time Adaptive Approach to Breast MRI Suggests ‘New Era’ of AI-Directed MRI
June 3rd 2025Assessing the simulated use of AI-generated suspicion scores for determining whether one should continue with full MRI or shift to an abbreviated MRI, the authors of a new study noted comparable sensitivity, specificity, and positive predictive value for biopsies between the MRI approaches.
Can Abbreviated MRI Have an Impact in Differentiating Intraductal Papilloma and Ductal Secretion?
June 3rd 2025For patients with inconclusive ultrasound results, abbreviated breast MRI offers comparable detection of intraductal papilloma as a full breast MRI protocol at significantly reduced times for scan acquisition and interpretation, according to a new study.
