FDA OKs Positrigo’s NeuroLF Brain PET Scanner

ETH Zurich spinoff Positrigo has earned U.S. Food and Drug Administration (FDA) clearance of its NeuroLF dedicated brain PET system.

The ultra-compact imaging device helps diagnose and monitor brain-related disorders like Alzheimer’s disease, brain tumors, epilepsy, Parkinson’s disease, and others. The system needs no special room conditions and lets patients get a brain scan in seated position, enabling functional imaging at the point of care.

The Swiss-based company said NeuroLF supports a paradigm shift in medical imaging, where a dedicated device can image a particular body part or organ. PET brain imaging is essential to accurately diagnose Alzheimer’s patients but currently available scanners are large and always combined with MRI or CT. Purchase and maintenance costs are also significant and a lot of space is needed, limiting the devices’ availability.

Regulatory approval for NeuroLF is anticipated later this year since the required MDR audit was passed successfully a few weeks ago, Positrigo said.

“It is not the first device of its kind which receives market clearance in the U.S. 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,” said Dr. Jannis Fischer, Positrigo’s co-founder and CEO. “We are excited to fulfill numerous pre orders in the US and to have first customers benefiting from our technology very soon. It is incredibly rewarding and I couldn’t be prouder of our team which worked tirelessly to achieve this important milestone.”