Zurich-based nuclear medical imaging device firm Positrigo’s positron emission tomography (PET) system, NeuroLF, has acquired market authorisation from the European Union (EU).
The ultra-compact diagnostic device is designed to assist in diagnosing and monitoring brain-related disorders like Alzheimer’s disease, brain tumours, epilepsy and Parkinson’s disease. The CE mark provides the company market access in its home continent, shortly after gaining clearance from the US Food and Drug Administration (FDA) in July.
Related: FDA approves BioIntelliSense’s BioButton wearable for patient monitoring
The market authorisation follows after the European Association of Nuclear Medicine (EANM) Neuroimaging Committee claimed that amyloid PET testing will be more widespread use in the future to better understand and more quickly diagnose Alzheimer’s disease, with the need for amyloid PET testing increasing by a factor of 20.
Jannis Fischer, co-founder and CEO of Positrigo, said: “At Positrigo, we seek to push the limits by developing and commercialising new types of medical imaging technologies. 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 like Alzheimer’s disease while setting a new standard in brain PET imaging.”
GlobalData’s Medical Devices database forecasts that the Alzheimer’s disease market will be worth $15.9bn globally by 2030, with more than 70 in vitro diagnostics for Alzheimer’s currently in development. Founded in 2015 as a spin-off of ETH Zurich, Positrigo has announced that it plans to partner with distribution partners in countries across Europe.
Osama Sabri, chairman of the Department of Nuclear Medicine at the University of Leipzig Medical Center, 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, allowing nuclear medicine physicians in Europe to offer a dedicated imaging modality to diagnose and monitor patients with brain-related disorders.” Elsewhere in the field of PET imaging GE HealthCare has received approval from the US FDA for its Flyrcado (flurpiridaz F 18) injection, a positron emission tomography (PET) myocardial perfusion imaging (MPI) agent to detect coronary artery disease (CAD).
