Canadian health authorities have licensed Hyperfine’s portable MRI, opening another market to the innovative device, the Guilford company announced Thursday.
The license allows the sale in Canada of the latest version of Hyperfine’s Swoop MRI machine, which uses deep learning (DL) software to improve image quality.
Hyperfine President and CEO Dave Scott said, “This regulatory clearance… is a significant milestone for Hyperfine, validating our technology and helping both Canadian patients and hospitals.”
Swoop’s size, portability and ease of use lends itself to deployment in remote areas, Scott said. “We believe our advanced disruptive technology will help bring great access to advanced diagnostic imaging at the point of care across North America.”
The Canadian license is part of Hyperfine’s global expansion strategy, with plans to go to market in the U.K. and Pakistan in 2022.
Casey Newhouse, a former executive at Johnson & Johnson and Edwards Lifesciences, was tapped to oversee Hyperfine’s expansion in Canada, the company said in a statement. Toronto-based medical distribution firm UpCare will direct marketing, distribution and sales of the Swoop system in Canada.
UpCare co-founder and Chief Commercial Officer Benoit Sai said, “We are always looking for innovations that have the potential to improve patient outcomes, access to new technology and healthcare economics.”
The U.S. Food and Drug Administration (FDA) approved the newest DL version of Swoop in November.
The Bill & Melinda Gates Foundation awarded a $3.3 million grant to Hyperfine in November to expand a global research program on the use of Swoop in developing countries.
Hyperfine went public in July, combining with brain-monitoring firm Liminal Sciences and HealthCor Catalio Acquisition Corp., a healthcare-focused SPAC, in a deal valued at $580 million.
Contact Liese Klein at lklein@newhavenbiz.com.
