Hyperfine has announced the CE approval of its latest AI-powered software for the Swoop® Portable MR Imaging® system under the European Medical Device Regulation.
This approval is a key milestone for positioning the Swoop® system for a broad launch across Europe, making portable, high-quality brain MR imaging more accessible for critical diagnostic decisions in a variety of healthcare settings.
The Swoop® system received its initial CE certification in 2023. Hyperfine expanded its global distribution network, forming partnerships with healthcare providers in thirteen European countries, including the five major markets.
This expansion aims to increase access to advanced portable brain MR imaging technology worldwide.
The new software improves scan times, which can help accelerate the diagnostic process, especially in emergency cases such as strokes where time is critical. Shorter scan times also reduce the impact of patient movement on image quality, enhancing overall diagnostic accuracy and efficiency.
The Swoop® Portable MR Imaging® system is for brain imaging in patients of all ages and is already available in selected international markets. It is a portable, ultra-low-field MRI device that provides valuable images of the brain, particularly when a full diagnostic MRI is not feasible.
When interpreted by a qualified healthcare professional, these images can aid in diagnosis. The Swoop® system is also CE-certified in the European Union and UKCA-certified in the UK.
Source: https://hyperfine.io/about/news/press-release-hyperfine-announces-european-launch-with-ce-approval
