GUILFORD, Conn. – December 9, 2021 —Hyperfine, Inc., creator of the first FDA-cleared portable magnetic resonance imaging MRI device, Swoop®, today announced the Health Canada licensing of Swoop as well as the commercial launch of the imaging system in Canada. The license of Swoop includes the recently FDA-cleared advanced reconstruction software using deep learning. With this license, the Swoop system is now available for purchase in Canada.
Casey Newhouse will lead Hyperfine’s expansion in Canada and be responsible for growing the adoption of the Swoop system. Newhouse brings 20 years of multinational medtech experience with a focus on stroke therapy, previously working in executive leadership roles at Johnson & Johnson and Edwards Lifesciences.
“This regulatory clearance in our third country is a significant milestone for Hyperfine, validating our technology and helping both Canadian patients and hospitals,” said Dave Scott, president and chief executive officer of Hyperfine. “Current MRI systems are limited by their size, cost and training requirements, especially in remote locations. By rethinking the MRI design, Swoop provides an easy-to-use, portable and affordable system, which can provide imaging beyond boundaries, wherever patients are. We believe our advanced disruptive technology will help bring great access to advanced diagnostic imaging at the point of care across North America.”

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UpCare, a Toronto-based national distributor of innovative medical technologies, specializing in value creation for Canadian healthcare providers, will execute marketing, distribution, and sales of the Swoop system in the country.
“We are always looking for innovations that have the potential to improve patient outcomes, access to new technology and Healthcare economics,” said Benoit Sai, co-founder and chief commercial officer of UpCare. “Hyperfine is truly leading the way with the Swoop portable MRI system, further strengthening our Neurosciences ecosystem. With Swoop’s addition, UpCare’s expanded product portfolio can provide a comprehensive continuum of care from diagnostic to monitoring.”
The Hyperfine system is designed to provide rapid imaging to allow physicians to make diagnoses and determine treatment for patients regardless of income or location. Swoop is being used around the world to address some of the limitations of current imaging technologies and to make MRI more accessible. Swoop wheels directly to the patient’s bedside, plugs into a standard electrical wall outlet, and is controlled by an off the shelf tablet.