This clearance comes just months after the company launched its eighth-generation software in January. The advanced software significantly reduces scan times across multiple magnetic resonance (MR) brain imaging sequences without sacrificing quality.
Guilford, Connecticut-based Hyperfine said in a news release that scan time reductions may enable Swoop images to speed up the diagnostic process in acute care settings. This could prove crucial for time-sensitive medical conditions like stroke. Reducing the overall acquisition time for sequences can also decrease the negative impact of patient motion on image quality.
The company says Swoop is the world’s first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system. Hyperfine aims to leverage AI and machine learning to advance ultra-low-field portable MR brain imaging technology and improve patient care.
“With the release of our ninth-generation AI-powered software, we continue to broaden the clinical utility and workflow fit of the Swoop system,” said Tom Teisseyre, COO at Hyperfine. “The balance between speed and image quality is crucial in acute care settings where early and timely information is essential to inform the best decisions for patients. We’re proud of every step we’ve taken with the Swoop system, learning from and responding to our user base and the broader medical community.”
