Positrigo has been awarded clearance in line with the Medical Device Regulation (MDR) and the associated CE Mark for Europe for its brain positron emission tomography (PET) system. It was only in July that NeuroLF, as the brain PET system is known, was approved for use on the US market by the FDA, which is the regulatory authority in the USA. NeuroLF is therefore the first device of its kind to obtain regulatory approval in both the USA and Europe, as the medtech firm based at Technopark Zurich explains in the corresponding press release.
“At Positrigo, we seek to push the limits by developing and commercializing new types of medical imaging technologies”, comments Jannis Fischer, co-founder and CEO of Positrigo, in the press release. For Prof. Dr. med. Osama Sabri, Director and Chairman of the Department of Nuclear Medicine at the University of Leipzig Medical Center, the market clearance for NeuroLF in Europe constitutes “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”.
Positrigo intends to sell the brain PET system by leveraging a network of established companies in selected countries across Europe. “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”, as Stefan Bircher, CCO at Positrigo, concludes. ce/hs
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