FDA Clears Dedicated Brain PET Imaging Device

The Food and Drug Administration (FDA) has granted 510(k) clearance to NeuroLF (Positrigo, Zurich, Switzerland), a compact PET imaging device specifically designed for the brain, which assists in the evaluation and monitoring of neurologic conditions. including, among others, Alzheimer disease (AD), Parkinson disease (PD), and brain tumors.

According to a statement from Positrigo, the clearance for NeuroLF coincides with a trend in the medical field whereby new devices are being utilized to perform imaging on specific parts of the body, including the brain, rather than the whole body. Such devices are smaller, easier to use, and more likely to be available at point of care. The NeuroLF device permits scanning of patients while they are in a seated position. Dedicated brain PET imaging in particular has applications in detecting the clinical features needed for the diagnosis of AD, enabling the use of certain disease-modifying therapies.

"Thanks to our excellent partner network we can rely on well-established and experienced companies which are ready to support us in this critical growth stage,” said Dr. Max Ahnen, Founder and COO of Positrigo. “I can't wait to see the first NeuroLF devices leaving our production floor to allow clinicians to offer high quality patient care."