Hyperfine has entered into agreements with experienced and accomplished distributors in Germany, Austria, Switzerland, and key Nordic markets.
 
With the Swoop system’s transformative and accessible platform, Hyperfine aims to serve more clinicians and patients needing brain imaging worldwide. Plans to introduce the system into international markets represent a significant step in the company’s commercial growth. With the recent addition of distributors covering Germany, Austria, Switzerland, and the major Nordic markets, along with previously appointed distributors in France, the United Kingdom, and Italy, Hyperfine is now positioned for commercial expansion into 12 European countries.
 
“We are thrilled with the initial feedback from clinicians in European sites. The positive feedback highlights the Swoop system’s potential to significantly impact adult and pediatric care throughout Europe,” Hyperfine President/CEO Maria Sainz said.
 
The system being introduced to the European markets is commercialized in the United States and represents the highest-performing Swoop system to date in terms of image quality, speed, and usability. The company’s track record of securing international approvals enables its expansion into global markets.
 
In addition to the company’s European expansion plans, Hyperfine announced in May 2024 a distribution agreement to develop Asian markets, including India.
 
The Swoop Portable MR Imaging system is U.S. Food and Drug Administration (FDA) cleared 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. is a health technology company that has redefined brain imaging with the Swoop system—the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of care. Hyperfine’s mission is to revolutionize 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 out of a passion for redefining brain imaging methodology and how clinicians can apply accessible diagnostic imaging to patient care.