Swiss nuclear medical imaging devices developer Positrigo has received the CE mark approval for its dedicated brain Positron Emission Tomography (PET) system, NeuroLF.
NeuroLF is an ultra-compact imaging device designed to support the diagnosis and monitoring of brain-related disorders, such as Alzheimer’s disease, brain tumours, epilepsy, and others.
Its regulatory approval in the European Union (EU) follows the US Food and Drug Administration (FDA) approval, granted in July this year.
Positrigo intends to commercialise its novel imaging technology in Europe through a network of established companies in selected countries.
Positrigo CCO Dr Stefan Bircher said: “Due to the fragmented healthcare system in Europe with different country-specific purchase mechanisms and healthcare reimbursement systems, it is most efficient to partner with local companies in selected countries.”
University of Leipzig Medical Centre department of nuclear medicine director and chairman Dr Osama Sabri said: “The CE mark of the NeuroLF system is another important milestone in the development of this dedicated brain PET system and represents a significant advance in the availability of brain PET imaging.”
According to the European Association of Nuclear Medicine (EANM) Neuroimaging Committee, amyloid PET is now at a turning point, clearing the path for early AD diagnosis.
Also, amyloid PET is anticipated to be more widely used in the future, for initiation and monitoring the effect of disease-modifying therapies on biological grounds.
The NeuroLF system is Positrigo’s first device and is said to advance the medical imaging sector by providing dedicated imaging capabilities for specific body parts or organs.
It uses mechanical, electronic, and software technological advancements, and allows patients to undergo brain scans while being seated.
Positrigo said that its NeuroLF system is much smaller and more affordable compared to the currently available clinical hybrid PET systems with a much larger footprint and weight.
Positrigo co-founder and CEO Jannis Fischer said: “The CE mark of the NeuroLF system is a testament to this, now offering healthcare professionals the potential to improve the diagnosis for people living with brain-related disorders while setting a new standard in brain PET imaging.”
