Zinger Key Points
- Hyperfine announced it secured clearance from the Food and Drug Administration for its new Swoop system.
- The Swoop system is the first FDA-cleared AI-powered portable MRI system for the brain.
- Get the Strategy to Trade Pre-Fed Setups and Post-Fed Swings—Live With Chris Capre on Wednesday, June 11.
Hyperfine, Inc. HYPR stock is trading higher Monday after the company announced it secured clearance from the Food and Drug Administration (FDA) for its new Swoop system.
What To Know: The Swoop system is the first FDA-cleared AI-powered portable MRI system for the brain.
The company said the system delivers the highest level of image quality, functionality and usability to date. Hyperfine further stated that Optive AI software plays a central role in delivering faster, higher-quality scans.
“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.
The new Swoop system is being used in NEURO PMR, a Hyperfine-sponsored study examining the clinical utility of portable MRI in neurology offices. The two participating sites have reported very positive feedback from both users and patients so far.
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HYPR Price Action: At the time of writing, Hyperfine stock is trading 40.7% higher at 84 cents, according to data from Benzinga Pro.
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