Radialis Medical submits 510 (k) FDA pre-market notification for its organ-targeted PET camera


THUNDER BAY & TORONTO, Ontario – (COMMERCIAL THREAD) – Radialis Medical today announced that it has submitted a 510 (k) pre-market notification to the United States Food & Drug Administration (FDA) for the Radialis PET Camera, a positron emission tomography system ( PET) targeting organs.

“Compared to whole-body PET scans, an organ-targeted PET camera positions the detectors in close proximity to the organ of interest for a better 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 enhanced sensitivity, spatial resolution and flexibility allowing for precision imaging of multiple organs with potentially as little as 1. / 10e the dose of radiotracer, ”he said.

Radialis Medical is now seeking FDA clearance to market its double-headed planar organ-targeting PET system. The system uses a silicon photomultiplier-based seamless detector array using patented light sharing technology to efficiently locate the radiation emission.

The detector electronics have built-in cooling to improve signal quality (patent pending) and high-speed data acquisition is optimized for low-dose imaging. The technology behind the system was developed in Dr. Reznik’s research lab at Lakehead University and the Thunder Bay Regional Health Research Institute (TBRHRI).

“Emerging radiotracers under development for PET imaging allow visualization of specific pathological processes 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 radiological medical imaging at Lakehead and Scientific and TBRHRI.

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

“The submission of the 510 (K) application is an important step forward as Radialis prepares to develop its new 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.

About Radialis Medical

Radialis Medical was founded as a joint venture of IRRTB and Lakehead University. . Radialis provides the best Positron Emission Tomography (PET) medical imaging systems targeting organs. Radialis’s advanced medical device manufacturing facility is located in Thunder Bay, Ontario. Follow Radialis Medical on twitter @RadialisMed.

Forward-looking statements

Statements in this press release that are not purely historical are forward-looking statements and include statements regarding beliefs, plans, expectations or intentions regarding the future. Although we believe that the forward-looking statements contained in this press release are reasonable, there can be no assurance that such forward-looking statements will prove to be correct. These forward-looking statements are made as of the date of this press release, and we assume no obligation to update any forward-looking statements.

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