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.
Azenta names new president and CEO
PHC announces launch of LiCellMo live cell metabolic analyzer targeting CGT advancements
Heron Therapeutics names new chief business officer
Expanse Medical names new chief executive officer and FlowPhysix board member
Qaelon Medical names new chief executive officer
Johnson & Johnson agrees acquisition of V-Wave
Nightingale Health gains UKCA certification and expands with new laboratory
Talphera enrols first subject in NEPHRO CRRT study
China Pharma Holdings anticipates launch of Dry Eye Disease Therapeutic Device in early 2025
SOPHiA DDM Platform achieves IVDR certification, enhancing diagnostic precision
Medtronic reports FDA approval of Simplera CGM; partners with Abbott
OncoBeta expands Rhenium-SCT (Skin Cancer Therapy) treatment services in Italy
Labcorp's PGDx elio plasma focus Dx receives US FDA De Novo marketing authorisation
Verici Dx announces completion of Thermo Fisher Scientific licensing agreement