Radialis Medical Submits FDA 510(k) Premarket Notification for its Organ-Targeted PET Camera

Thunder Bay and Toronto, Ontario, Canada – Radialis Medical today announced that it has submitted a U.S. Food & Drug Administration (FDA) 510(k) premarket notification for the Radialis PET Camera, an organ-targeted positron emission tomography system.

“Compared to whole-body PET scanners, an organ-targeted PET camera positions detectors in close proximity to the organ of interest for a higher quality image of a smaller field of view,” said Michael Waterston, CEO of Radialis Medical.

“Our compact high-resolution PET camera would be an ideal addition to clinics with whole-body PET systems due to its improved sensitivity, spatial resolution, and flexibility enabling precision imaging of multiple organs with potentially as little as 1/10th the radiotracer dose,” he said.

Radialis Medical is now seeking FDA clearance to market its planar dual-head organ-targeted PET system. The system employs a seamless silicon photomultiplier-based detector array using patented light-sharing technology to efficiently localize radiation emission.

The detector electronics have integrated cooling to enhance signal quality (patent pending), and the high-throughput data acquisition is optimized for low-dose imaging. The underlying technology of the system was developed in Dr. Reznik’s research laboratory at Lakehead University and the Thunder Bay Regional Health Research Institute (TBRHRI).

“Emerging radiotracers being developed for PET imaging allow specific disease processes to be visualized and facilitate precision medicine. The Radialis PET Camera is the first organ-targeted PET system focused on low-dose PET imaging of multiple diseases,” said Dr. Alla Reznik, Professor and Tier 1 Canada Research Chair in Physics of Radiation Medical Imaging at Lakehead and a Scientist and the TBRHRI.

The University Health Network-Princess Margaret Cancer Centre (UNH-PMCC) in Toronto is currently using the Radialis PET Camera in a study titled “Evaluating Positron Emission Mammography Imaging of Suspicious Breast Abnormalities” (ClinicalTrials.gov Identifier: NCT03520218).

“The submission of the 510(K) application is a great milestone to achieve as Radialis moves to develop their novel cancer detection imaging equipment. Equally exciting is the development of manufacturing facilities in Thunder Bay to produce this new medical device," said Dr. Andrew P. Dean, Vice-President, Research and Innovation, Lakehead University.

The Radialis PET Camera