FDA Clears Hyperfine’s Updated AI-Powered Swoop System Software

Hyperfine Inc. has received U.S. Food and Drug Administration (FDA) clearance of updated Swoop system software. Built on a robust AI foundation, the latest software brings image quality enhancements to the Swoop system’s diffusion-weighted imaging (DWI) sequence.
 
With this latest software update, Hyperfine expands the Swoop system’s AI denoising capabilities by incorporating advanced image post-processing into the DWI sequence. The system’s other sequences (T1, T2, and FLAIR) previously benefited from this AI feature. Denoising enables a crisper image that potentially helps clinicians more accurately diagnose, treat, and monitor patients undergoing brain imaging.
 
“We believe in making brain imaging more accessible, clinically relevant, and actionable. We continue to make meaningful progress across all sequences. With this significant and most recent update, we now incorporate deep learning into our DWI sequence,” Hyperfine Chief Operating Officer Tom Teisseyre said. “These imaging improvements will serve a critical role in enhancing image quality for healthcare professionals in time-sensitive environments.”

Hyperfine will roll out the updated Swoop system software in the coming months. The world’s first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of care, the Swoop system received initial FDA clearance in 2020 as a portable magnetic resonance brain imaging device for producing images that display the head’s internal structure where a 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 has been approved for brain imaging in several countries, including Canada and Australia, has UKCA certification in the United Kingdom, CE certification in the European Union, and is also available in New Zealand.
 
“Our eighth FDA software clearance in three years for the Swoop system underscores our relentless drive for innovation and continuous improvement,” Hyperfine President/CEO Maria Sainz stated. “Our focus remains on providing quality brain imaging to more providers and patients in more sites of care. More than milestones, it’s about reshaping patient care, empowering clinicians, and advancing brain imaging.”
 
Hyperfine is a medical technology company that is redefining brain 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 the ways in which clinicians can apply accessible diagnostic imaging to patient care. Traditionally, access to costly, stationary, conventional MRI technology can be inconvenient or not available when needed most. With the portable, ultra-low-field Swoop system, Hyperfine, Inc. is redefining the neuroimaging workflow by bringing brain imaging to the patient’s bedside.