US-based health technology company Hyperfine has received the US Food and Drug Administration (FDA) clearance for its next-generation Swoop system, powered by AI.
The Swoop Portable MR Imaging (V2) System is a portable, ultra-low-field MRI device approved for brain imaging in patients of all ages.
It is designed to produce images of the head’s internal structure when a full diagnostic examination is not feasible, which can be used in diagnosis.
The next-gen MRI system, powered by the company’s in-house Optive AI software, offers enhanced image quality, functionality, and usability, setting a new standard for brain imaging.
Based on five years of real-world application across seven continents, the system has been developed to deliver superior signal-to-noise ratio.
When combined with the Optive AI software, the system results in improved resolution, uniformity, and faster acquisition times.
The advancements are expected to increase the adoption of the Swoop system across various clinical settings.
Hyperfine president and CEO Maria Sainz said: “This next-generation hardware and the Optive AI software platform begin a new chapter for the adoption of AI-powered portable MRI. This clearance is the most significant innovation in the history of Hyperfine.
“We plan to launch the new Swoop system across hospital and office settings in the US, and we believe the new Swoop system performance will delight patients and providers, reduce the learning curve for users, and drive meaningfully faster adoption.”
The new Swoop system’s user-friendly design is tailored to address a wide range of patients, including paediatric, elderly, and anxious individuals, making MRI more accessible.
Hyperfine collaborated with portable MRI programmes, such as Jefferson Abington, for the development of the new Swoop system.
The partnerships have contributed to critical hardware and software enhancements that improve clinical utility of the device.
The Swoop system is currently being used in the NEURO PMR study, sponsored by Hyperfine, to evaluate the clinical utility of portable MRI in neurology offices.
Initial feedback from the two participating sites has been overwhelmingly positive.
By integrating advanced AI with a reimagined portable MRI platform, Hyperfine aims to revolutionise brain imaging delivery.
The Swoop system is expected to support its strategy to expand its use across diverse care environments, including critical care, emergency, and clinic settings, among other areas.
NEURO PMR study principal investigator Laszlo Mechtler said: “Based on my extensive experience in the NEURO PMR study, I believe the new Swoop system marks a remarkable advancement in image quality while maintaining an affordable and compact design.
“It is a compelling solution for neurology practices who want to offer on-site, cost-effective brain imaging to enhance patient care, convenience, and comfort.”
