FDA Clears Positrigo's Portable Brain PET System
The FDA has cleared Positrigo’s NeuroLF Brain PET System, a device designed for diagnosing multiple brain disorders. The system's clearance could expand access to advanced neurological imaging, particularly in outpatient and potentially mobile environments.
- Zurich-based Positrigo, a 2018 spin-off from ETH Zurich, has raised over $18.2 million in funding to develop and commercialize the NeuroLF system. - The system is designed for smaller sites of care, weighing 530 kg (1,170 lbs) and requiring no specialized room modifications and a minimal footprint of 2.7 by 4 meters. - This clearance aligns with major industry trends, as advanced outpatient imaging is projected to grow by 14% over the next decade, with PET imaging forecast to be the fastest-growing modality at 23%. - The approval is timely, coinciding with the market entry of new Alzheimer's therapies that rely on PET scans for diagnosis and monitoring, which is expected to increase demand. - A significant reimbursement change from the Centers for Medicare & Medicaid Services (CMS), effective January 1, 2025, will separately pay for high-cost PET radiopharmaceuticals in outpatient hospital settings, improving the financial viability of offering these scans. - While Positrigo notes it is not the first dedicated brain PET scanner to receive clearance, it aims to compete on its patient-centric design, which allows individuals to be scanned while seated. - The broader mobile imaging market is also expanding, with PET/CT services projected to be the fastest-growing segment with a compound annual growth rate of 5.61% through 2031.
