Nasdaq

Hyperfine's (HYPR) Swoop System Gets New FDA-Cleared Software

Hyperfine HYPR recently announced the receipt of FDA 510(k) clearance for the ninth generation of its AI-powered Swoop system software. It is the world’s first FDA-cleared portable magnetic resonance ...
Morningstar

Hyperfine Announces FDA Clearance of a New Next-Generation Swoop® System Powered by Optive AI™ Software, Delivering a Transformative Leap in Image Quality

Hyperfine Announces FDA Clearance of a New Next-Generation Swoop® System Powered by Optive AI™ Software, Delivering a Transformative Leap in Image Quality This major Swoop® system scanner redesign and ...
Nasdaq

Hyperfine announces CE approval of Swoop system software

Hyperfine (HYPR) announced CE approval of its latest generation of AI-powered Swoop system software under the European Medical Device Regulation. This approval marks a step in positioning Hyperfine ...
Business Wire

Hyperfine, Inc. Receives FDA Clearance for Updated AI-powered Software with Improved Image Quality for All Swoop® System Sequences

GUILFORD, Conn.--(BUSINESS WIRE)--Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking medical device company that has redefined brain imaging with the world’s first FDA-cleared portable magnetic ...
WDAF-TV

Hyperfine, Inc. Announces FDA Clearance for Improved AI-Powered Software and Expanded Field of View for the Swoop® Portable MR Imaging® System

GUILFORD, Conn., Feb. 13, 2023 (GLOBE NEWSWIRE) -- Hyperfine, Inc., the groundbreaking medical device company that created the Swoop ® system, the world’s first FDA-cleared portable magnetic resonance ...
Morningstar

Hyperfine Begins Commercial Launch of Optive AI™ Software, Bringing Substantially Improved Image Quality to the Installed Base of Swoop® Systems

Optive AI™ software has now been installed in an initial set of hospitals and neurology offices across the U.S., marking the beginning of expanded access to transformative, AI-powered image quality ...