FDA Clears Positrigo's Portable Brain PET System
What happened
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.
Why it matters
- 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.
Key numbers
- - 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 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.
What happens next
- 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.
- 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.
Quick answers
What happened in 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.
Why does FDA Clears Positrigo's Portable Brain PET System matter?
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.
