FDA Clears 9th Generation of Hyperfine’s AI-Powered Swoop System Software

Hyperfine has gained U.S. Food and Drug Administration (FDA) clearance for the ninth generation of its artificial intelligence (AI)-powered Swoop system software.

The new software, according to the company, significantly lowers scan times across multiple magnetic resonance (MR) sequences without sacrificing image quality. The scan time reductions may allow Swoop system images to help speed the diagnostic process in acute care settings. Reducing sequence acquisition time can also reduce patient motion’s negative impact on image quality.

The total number of Hyperfine AI-powered marketing authorizations places the company in a leading position on the FDA’s Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices list.

“Timely MR brain imaging is essential for clinicians making critical treatment decisions, particularly in acute neurological episodes like strokes,” said Professor Adnan Siddiqui, MD, Ph.D., from the University of Buffalo. “We have been an active site in the ACTION PMR study assessing the use of the Swoop system in stroke diagnosis, and this latest software will help the Swoop system more seamlessly integrate into stroke workflows. It is wonderful to see Hyperfine respond quickly to clinical feedback and continue to innovate to improve the Swoop system.”

“With the release of our ninth-generation AI-powered software, we continue to broaden the clinical utility and workflow fit of the Swoop system,” added 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.”