Hyperfine Announces FDA Clearance Of Software Update That Enables Faster Acquisition Of Best-In-Class Ultra-Low-Field Brain Images

The total number of Hyperfine AI-powered marketing authorizations places the company in a leading position on recently published FDA list.

Hyperfine (NASDAQ:HYPR), the groundbreaking medical device company that has redefined brain imaging with the world's first FDA-cleared portable magnetic resonance brain imaging system—the Swoop® system—today announced the clearance of the ninth generation of AI-powered Swoop® system software. This advanced software significantly reduces scan times across multiple MR sequences without sacrificing image quality. The U.S. Food and Drug Administration (FDA) clearance of this software further solidifies Hyperfine as a leader in AI-powered health technology.

These scan time reductions may enable Swoop® system images to help speed up the diagnostic process in acute care settings, which is crucial for time-sensitive medical conditions such as stroke, where every second counts. Reducing the overall acquisition time for sequences can also decrease the negative impact of patient motion on image quality.