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Hyperfine Announces FDA Clearance of Software Update That Enables Faster Acquisition of Best-in-Class Ultra-Low-Field Brain Images
Hyperfine (Nasdaq: HYPR) has received FDA clearance for its ninth-generation AI-powered Swoop® system software, significantly reducing scan times for brain imaging without compromising image quality. This advancement positions Hyperfine as a leader in AI-powered health technology, potentially speeding up diagnoses in acute care settings, particularly for time-sensitive conditions like stroke. The software update may also help mitigate the impact of patient motion on image quality.

Professor Adnan Siddiqui from the University of Buffalo highlighted the importance of this development for stroke diagnosis workflows. Hyperfine's commitment to AI innovation is evident in its leading position on the FDA's AI/ML-Enabled Medical Devices list. Tom Teisseyre, Chief Operating Officer at Hyperfine, emphasized the company's focus on balancing speed and image quality to inform better patient care decisions in acute settings.
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