Summary: Positrigo, a Swiss company, received FDA clearance for its NeuroLF brain PET system, designed to diagnose and monitor brain disorders such as Alzheimer’s and Parkinson’s. The compact device allows seated scans with minimal space requirements, enhancing patient care and meeting the growing demand for brain PET scans.

Key Takeaways:

  • FDA Clearance: Positrigo’s NeuroLF brain PET system has received FDA clearance, marking a significant milestone for the company.
  • Innovative Design: The ultra-compact NeuroLF system supports functional brain imaging in a seated position, requiring minimal space and no special room modifications.

Positrigo, a Swiss-based company developing nuclear medical imaging devices to advance functional brain imaging, has received U.S. Food and Drug Administration (FDA) clearance of its dedicated brain PET system NeuroLF.

Device Features and Applications

The NeuroLF imaging device is designed to be ultra-compact and assists in diagnosing and monitoring brain-related disorders like Alzheimer’s disease, brain tumors, epilepsy, Parkinson’s disease, and others.

“It is not the first device of its kind which receives market clearance in the US 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, 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.”

Shift in Medical Imaging

The NeuroLF system supports a shift in medical imaging where a dedicated device allows for imaging of a particular body part or organ. Harnessing the advancement in mechanical, electronic, and software developments, this system requires only minimal space and no special room modifications, allowing patients to receive a brain scan in a seated position and enabling functional imaging at the point-of-care.

With the existing pre-orders and the demand from customers worldwide, the company says it is gearing up its production capabilities.

“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,” Dr. Max Ahnen, co-founder and COO. “I can’t wait to see the first NeuroLF devices leaving our production floor to allow clinicians to offer high-quality patient care.”