Hyperfine Initiates Sales of Next-Gen Swoop System With Optive AI Software

Hyperfine Inc. is marking the first commercial sales of its next-generation Swoop system powered by proprietary Optive AI software. Two hospitals that purchased the first units plan to utilize the technology in intensive care and emergency department settings.

Initial sales of the next-generation Swoop system—purchased by two top-tier hospitals in the northeastern United States—demonstrate a strong market response following U.S. Food and Drug Administration (FDA) clearance and mark a critical step toward the widespread clinical adoption of portable brain imaging with diagnostic-level clarity, the company claims.

“This marks the start of a new phase for Hyperfine—one where our vision to transform MRI access is driven by a new system that is commercially ready, is clinically valuable, has outstanding image quality and functionality, and is garnering strong customer interest,” Hyperfine President/CEO Maria Sainz stated. “Attaining the milestone of first commercial sales and deliveries of the new Swoop system just weeks after FDA clearance is the result of seamless execution across the organization—from industry-leading product development to accelerated clearance to rapid manufacturing ramp to initial sales. We are excited about the momentum with the new Swoop system and the growth we anticipate in the second half of 2025 and beyond.”

The new Swoop system features innovations specifically engineered to deliver the highest signal-to-noise ratio, which, when paired with the Optive AI software, achieve exceptional image quality, including improved resolution, uniformity, and faster acquisition times, Hyperfine contends. This new level of image quality can potentially dramatically drive the adoption of the Swoop system across sites of care and multiple clinical applications. The new Swoop system also delivers a user and patient-centric design to accommodate a broad patient population—especially beneficial for pediatric, elderly, or anxious patients—making MRI more accessible for all.

The Swoop Portable MR Imaging (V2) System is FDA cleared for brain imaging in patients of all ages. It is a portable, ultra-low-field magnetic resonance imaging device for producing images that display the head’s internal structure 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.

Hyperfine Inc. is the 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 professional care. 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 clinicians can apply accessible diagnostic imaging to patient care.