FDA Clears Dedicated Brain PET System
Positrigo announced FDA clearance of its dedicated brain PET system, NeuroLF. This imaging device is ultra-compact and assists in diagnosing and monitoring of brain related disorders like Alzheimer disease (AD), Brain Tumors, Epilepsy, Parkinson 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," says 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."
The NeuroLF system supports a paradigm shift in medical imaging where a dedicated device allows for imaging of a particular body part or organ. What is well established in cardiac (heart) imaging is just starting now for the brain also. By harnessing the advancement in mechanical, electronic and software developments, this system requires only minimal space and no special room modifications, allows patients to receive a brain scan in a seated position and enables functional imaging at the point-of-care.
AD is the most common form of dementia, accounting for ~70% of all dementias in those over 60. The early diagnosis is of utmost importance and PET imaging of the brain is essential for the accurate diagnosis of AD patients.
Positrigo is also addressing a global market with growing demand in Europe and Asia. For the European market the regulatory approval is expected for later this year as the required MDR audit has been passed successfully a few weeks ago.
Dr Max Ahnen, co-founder and COO is excited about this next step: "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. I can't wait to see the first NeuroLF devices leaving our production floor to allow clinicians to offer high quality patient care."