NeuroLF from Positrigo receives European approval

Positrigo has received approval for its brain positron emission tomography (PET) system in accordance with the Medical Device Regulation(MDR) and the associated CE marking for Europe. The brain PET NeuroLF was only approved for the US market by the FDA in July. This makes NeuroLF the first device of its kind that can be sold in both the USA and Europe, explains Medtech, which is based in Technopark Zurich, in a press release.

"At Positrigo, we want to push the boundaries by developing and commercializing novel medical imaging technologies," Jannis Fischer, co-founder and CEO of Positrigo, is quoted as saying in the press release. For Prof. Osama Sabri, MD, Director and Chairman of the Department of Nuclear Medicine at Leipzig University Hospital, the approval of NeuroLF in Europe "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, enabling nuclear medicine physicians in Europe to offer a dedicated imaging modality for the diagnosis and monitoring of patients with brain-related diseases".

Positrigo intends to distribute the brain PET in selected European countries via a network of established companies. "Due to the fragmented healthcare system in Europe with different country-specific purchasing mechanisms and reimbursement systems, it is most efficient to work with local companies in the relevant European countries," says Stefan Bircher, CCO at Positrigo. ce/hs