Zurich - Positrigo has obtained market approval from the U.S. regulator, the FDA, for its NeuroLF brain PET system. This will enable the company to meet the strong demand for these imaging diagnostic devices in the U.S.

Positrigo, which specializes in nuclear medical imaging devices, has obtained clearance from the U.S. Food and Drug Administration (FDA) for its brain PET system NeuroLF, according to a company press release. The Technopark Zürich-based company has made its Positron Emission Tomography (PET) scanner ultra-compact, so that patients can receive a brain scan in a seated position even in smaller treatment units. The NeuroLF is used to diagnose and monitor neurodegenerative diseases such as Alzheimer’s, Parkinson’s, amyotrophic lateral sclerosis (ALS), epilepsy and brain tumors, among others. As the press release explain, systems that have previously been used to diagnose heart disease are also effective for brain disorders. The FDA approval will enable broad market access, as new treatments for Alzheimer’s disease have recently also been approved.

Dr Jannis Fischer, co-founder and CEO of Positrigo, says that although this is not the first device of its kind to receive market clearance in the U.S., the company believes that the patient-centric and customer-driven design and development efforts over the last couple of years have put it in “pole position” to offer the best imaging solution to meet the increased demand for brain PET scans. He adds that Positrigo is “excited to fulfill numerous pre-orders in the U.S.” and to enable the first customers to benefit from the technology very soon. “I couldn’t be prouder of our team, which worked tirelessly to achieve this important milestone.”

The press release says that the FDA approval represents an important milestone for Positrigo, which was established in 2018 as a spin-off of the Swiss Federal Institute of Technology in Zurich (ETH). ce/ww

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