Hyperfine Inc. is finalizing European expansion plans for its Swoop system, reaching distribution agreements for France, Italy, and the United Kingdom.
 
Last year, Hyperfine obtained CE certification under the EU MDR and UKCA certification in the United Kingdom for its latest hardware and eighth-generation AI-powered software. The system the company is introducing to the European markets is commercialized in the United States and is the highest performing Swoop system to date in terms of image quality and usability. The Swoop system can expand the existing imaging market with its platform to serve more clinicians and patients needing brain imaging, according to the company.
 
“There is a growing global demand for accessible MR brain imaging, which the Swoop system can meet. These strategic distributor partnerships enable a broader market footprint for our business beyond our direct commercial team in the U.S. 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 represent significant additional opportunities for our business globally,” Hyperfine President/CEO Maria Sainz said. “We are very encouraged by the high interest level and positive feedback from international clinicians thus far.”
 
In conjunction with its distribution agreements, Hyperfine Inc. expanded its management team, naming Enrico Barini as international business development director. Barini is tasked with building the framework for the company’s European business and driving the Swoop system’s international introduction through increased awareness and adoption. Barini joins the company with deep expertise in commercial operations and extensive imaging and capital experience, most recently from ViewRay Inc. and Boston Scientific Corporation.
 
“We are thrilled to embark on the exciting journey of bringing the Swoop system to additional global markets,” Hyperfine Vice President of Commercial Dave Castiglioni stated. “By expanding into these markets, we can revolutionize 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.”
 
The Swoop Portable MR Imaging system is cleared by the U.S. Food and Drug Administration (FDA) for brain imaging of patients of all ages. It is a portable, ultra-low-field magnetic resonance imaging device for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. The Swoop system also has CE certification in the European Union and UKCA certification in the United Kingdom. The Swoop system is commercially available in a select number of international markets.
 
Hyperfine Inc. aims to improve patient care globally through transformational, accessible, clinically relevant diagnostic imaging. Founded by Dr. Jonathan Rothberg in a technology-based incubator called 4Catalyzer, Hyperfine scientists, engineers, and physicists developed the Swoop system to redefine brain imaging methodology and the ways in which clinicians can apply accessible diagnostic imaging to patient care.