Connecticut-based company Hyperfine has secured CE marking under the European Medical Device Regulation for its Swoop portable brain MRI system.
The company in 2023 secured initial CE certification for the Swoop system. Hyperfine said this latest approval will help position the company to launch the system broadly across Europe. Hyperfine in 2024 expanded its global distribution network with partnerships established in 13 European countries, including the five major European markets.
The Swoop system reduces scan times, which speeds the diagnostic process in acute care settings, Hyperfine said.
