Positrigo, a Swiss nuclear medical imaging devices developer, has received clearance from the US Food and Drug Administration (FDA) for its NeuroLF brain positron emission tomography (PET) system.
The ultra-compact brain PET scanner is designed to support diagnosing and monitoring brain-related disorders such as Alzheimer’s disease (AD), brain tumours, epilepsy, Parkinson’s disease, and others.
The NeuroLF system, which is Positrigo’s first device, is said to advance the medical imaging sector by offering dedicated imaging capabilities for specific body parts or organs.
Using mechanical, electronic, and software technological advancements, the system requires minimal space and no special room modifications.
Patients can undergo brain scans while being seated, enabling functional imaging right at the point of care, Positrigo said.
The development of a dedicated brain PET device follows the recent FDA approval of another disease-modifying therapy for Alzheimer’s disease earlier this month.
The clearance marks the third medication to enter the market in the US, following two others approved last year.
Positrigo co-founder and CEO Jannis Fischer said: “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.
“We are excited to fulfil 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.”
Positrigo is also focusing on addressing a global market with rising demand in Europe and Asia.
Regulatory approval for the European market is anticipated later this year, following the completion of the required medical device regulation (MDR) audit a few weeks ago.
The Swiss company said that it is increasing its production capabilities given the existing pre-orders and strong global customer demand.
Positrigo is a spin-off of ETH Zurich and is backed by various private investors, the Swiss government, and the European Innovation Council.
