Hyperfine has announced that it has entered into agreements with three experienced and accomplished distributors to support commercial expansion plans of the Swoop system—the “first” US Food and Drug Administration (FDA)-cleared portable magnetic resonance (MR) brain imaging system—into European markets, with an initial focus on France, the UK, and Italy.
In 2023, Hyperfine obtained CE certification under the EU Medical Device Regulation (MDR), and UK Conformity Assessment (UKCA) certification in the UK, for its latest hardware and eighth-generation artificial intelligence (AI)-powered software.
The system the company is introducing to European markets is commercialised in the USA and is the highest performing Swoop system to date in terms of image quality and usability, according to a Hyperfine press release. The company further states that introducing the Swoop system into international markets is a significant step in supporting the commercial growth of Hyperfine, adding that the Swoop system can expand the existing imaging market with its “transformative, affordable and accessible” platform to serve more clinicians and patients needing brain imaging.
“There is a growing global demand for accessible MR brain imaging, which the versatile Swoop system can meet,” said Maria Sainz, president and chief executive officer of Hyperfine. “These strategic distributor partnerships enable a broader market footprint for our business beyond our direct commercial team in the USA. The clinical applications of our Swoop system in international markets will also expand from critical care inside hospitals to other professional healthcare facilities, such as outpatient clinics and offices. The use of the Swoop system in Alzheimer’s disease and acute stroke represents significant additional opportunities for our business globally. We are very encouraged by the high interest level and positive feedback from international clinicians thus far.”
In addition, Hyperfine has announced the expansion of its management team, with Enrico Barini joining as international business development director. In this role, Barini will build the framework for the company’s business in Europe and drive the international introduction of the Swoop system by building awareness and adoption, as per the recent release. Barini joins the company with “deep expertise” in commercial operations, and extensive imaging and capital experience—most recently from ViewRay and Boston Scientific Corporation.
“We are thrilled to embark on the exciting journey of bringing the Swoop system to additional global markets,” said Dave Castiglioni, vice president of Commercial at Hyperfine. “By expanding into these markets, we can revolutionise healthcare delivery, and significantly impact patient outcomes and cost of care. We are committed to leveraging our expertise and partnerships to drive positive change in global healthcare.”
