Medical device company Hyperfine (Nasdaq: HYPR) announced on Wednesday that it has received FDA clearance for its ninth-generation AI-powered Swoop system software, significantly reducing scan times without compromising image quality. This update enhances the world's first portable magnetic resonance brain imaging system, reaffirming Hyperfine's leadership in AI-powered health technology.
The new software accelerates the diagnostic process in acute care settings, crucial for time-sensitive conditions like stroke. By reducing acquisition times, the software minimises the impact of patient motion on image quality.
Hyperfine's extensive AI-powered marketing authorisations place it at the forefront of the FDA's AI/ML-Enabled Medical Devices list. The Swoop system, cleared by the FDA for brain imaging in patients of all ages, is also CE and UKCA certified and available in select international markets.
Founded by Dr Jonathan Rothberg at 4Catalyzer, Hyperfine aims to revolutionise patient care globally with accessible, clinically relevant diagnostic imaging.
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