FDA Clears Positrigo’s NeuroLF Brain PET System for the Diagnosis of Multiple Brain Disorders

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The FDA has granted clearance to Positrigo’s NeuroLF brain positron emission tomographic (PET) system, which the company said represents a major advancement in functional brain imaging. The device is designed to diagnose and monitor brain disorders such as Alzheimer disease, brain tumors, epilepsy, and Parkinson disease. As the company’s first brain PET system approved in the United States, Positrigo is currently preparing for global market expansion, with European regulatory approval anticipated later this year.¹

"It is not the first device of its kind which receives market clearance in the US, but we believe that our patient-centric and customer-driven design and development efforts over the last couple of years, brought us into the pole position to offer the best imaging solution to address the increased demand of brain PET scans," says Jannis Fischer, co-founder, CEO, Positrigo, in a press release. "We are excited to fulfill numerous pre orders in the US and to have first customers benefiting from our technology very soon. It is incredibly rewarding, and I couldn't be prouder of our team which worked tirelessly to achieve this important milestone."

Positrigo reports that the NeuroLF brain PET system requires only minimal space and no special room modifications, allowing patients to receive a brain scan in a seated position. Additionally, the device enables functional imaging at the point-of-care.

The approval comes at a time when the demand for brain PET scans is increasing, partially due to recent FDA approvals of Alzheimer disease therapies, according to Positrigo. Alzheimer accounts for an estimated 70% of all dementias in patients over 60 years of age, while there were over 55 million people worldwide living with dementia in 2020. By 2050, it is believed that this number will reach 139 million people.¹

According to a 2016 study published in the Journal of Neuropsychiatry and Clinical Neurosciences, PET imaging demonstrated a 57% annual growth rate after 2004. Despite having a number of advantages, the authors of the study said that there were limitations in using PET neuroimaging as a diagnostic tool.²

“There are several methodological issues that can degrade PET images,” report the authors of the study. “One of the most important is Compton scatter. Interaction of one or both of the photons with electrons causes varying degrees of change in direction, artifactually shifting the LOR. Since Compton scatter decreases the energy of the photons, some scatter can be removed by setting an energy threshold. However, some scattered photons are able to hit detectors with energy above the threshold. Therefore, mathematical scatter correction is also required. In addition, photons can be lost to photoelectric absorption or severe Compton scatter in the tissue, resulting in attenuation artifact.”

However, the researchers also explained that PET has clinical value when it can contribute to differential diagnosis, enable earlier diagnosis, monitor therapeutic efficacy, and/or alter clinical management. Further, the sensitivity and specificity of the radiotracer, the FDA-approved uses of the radiotracer, and the evidence that the PET scan will provide clinically useful information remain vital to successful implementation of the device.²

"Thanks to our excellent partner network we can rely on well-established and experienced companies which are ready to support us in this critical growth stage,” said Max Ahnen, co-founder, chief operating officer, Positrigo, in the press release. “I can't wait to see the first NeuroLF devices leaving our production floor to allow clinicians to offer high quality patient care."

References

1. Positrigo Receives FDA Clearance for Breakthrough Brain PET System. PR Newswire. July 16, 2024. Accessed July 17, 2024. https://www.prnewswire.com/news-releases/positrigo-receives-fda-clearance-for-breakthrough-brain-pet-system-302197969.html

2. Clinical Positron Emission Tomography (PET) Neuroimaging: Advantages and Limitations as a Diagnostic Tool. Psychiatry Online. April 19, 2016. Accessed July 17, 2024. https://psychiatryonline.org/doi/10.1176/appi.neuropsych.16030044