Hyperfine, Inc. Swoop® Portable MR Imaging® System Receives CE Marking After Meeting Comprehensive New EU MDR Regulations
GUILFORD, Conn., Feb. 21, 2023 (GLOBE NEWSWIRE) -- Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking medical device company that created the Swoop® system, the world's first FDA-cleared portable MRI system, today announced CE Marking for the product.
- GUILFORD, Conn., Feb. 21, 2023 (GLOBE NEWSWIRE) -- Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking medical device company that created the Swoop® system, the world's first FDA-cleared portable MRI system, today announced CE Marking for the product.
- While the company will maintain its commercial focus in the U.S. in 2023, CE Marking opens the door for potential future commercial expansion into the European Economic Area (EEA).
- To receive CE Marking, medical device companies must comply with the European Commission Regulation (EU) No.
- EU MDR dictates the European distribution of medical devices, and compliance is mandatory to legally market and sell products in the EEA.