Hyperfine announces FDA clearance of Swoop system

Hyperfine (HYPR) announced FDA clearance that includes an entirely new portable MRI scanner powered by the proprietary Optive AI software. The company said, “Swoop system scanner redesign and Optive AI software elevate the AI-powered portable MRI experience for clinicians and their patients across multiple sites of care.” “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,” said Maria Sainz, President and CEO of Hyperfine.