Thunder Bay, Ontario, Canada – Radialis Inc. today announced that it has received Health Canada clearance to market its advanced medical imaging system, the PET Imager, which is a next-generation, organ-targeted positron emission tomography (PET) system designed to improve diagnostic accuracy and care for cancer patients across Canada.
The Radialis PET Imager empowers physicians with high-resolution molecular imaging that enables earlier and more precise detection of disease, particularly in hard-to-image or small areas of the body. For patients, this means access to more accurate diagnoses, better monitoring of treatment response, and the potential for more personalized care.
“This approval marks a major milestone not only for Radialis, but also for patients who deserve the most advanced imaging tools available,” said Wayne Schnarr, Board Chair. “By providing greater image clarity with lower radiation exposure and improved access to targeted diagnostics, the Radialis PET Imager supports faster, more informed decisions about patient care. With FDA clearance already in place, this Health Canada clearance furthers our commitment to delivering impactful innovation to clinicians and patients in North America.”
Unlike traditional whole-body PET systems, the Radialis PET Imager is designed for close-range, organ-specific imaging, such as the breast or head and neck, using a compact footprint that integrates easily into existing nuclear medicine facilities. Its heightened sensitivity to radiotracers enables high spatial resolution imaging, expanding clinical possibilities with novel, organ-specific tracers—potentially transforming how diseases like cancer are detected and managed.
Intended Use
The Radialis PET Imager is intended to image and measure the distribution of injected positron-emitting radiopharmaceuticals in human beings to evaluate various metabolic and physiologic functions within the body.
Device Description
The PET Imager is a high-resolution, small field-of-view PET imaging system developed for close-range, organ-targeted imaging. The unique planar detector system collects gamma rays emitted by injected radiopharmaceuticals and generates detailed images reflecting their location in the body.
About Radialis
Radialis develops best-in-class, organ-targeted PET imaging systems based on proprietary technology discovered at Lakehead University. With advanced manufacturing operations in Thunder Bay, Ontario, Radialis is dedicated to advancing molecular imaging and enhancing patient care. Learn more at www.radialis.com.
Forward-Looking Statement
Statements in this press release that are not purely historical are forward-looking statements and include any statements regarding beliefs, plans, expectations or intentions regarding the future. Although we believe that any forward-looking statements contained in this press release are reasonable, there can be no assurance that any such forward-looking statements will prove to be accurate. These forward-looking statements are made as of the date of this news release, and we assume no obligation to update the forward-looking statements.
Media Contact
Wayne Schnarr
info@radialis.com
