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Hyperfine, Inc. Swoop® Portable MR Imaging® System Receives CE Marking After Meeting Comprehensive New EU MDR Regulations
CE Marking for the company’s portable MRI system with AI-powered imaging software demonstrates that the system complies with safety and performance
About this update from Hyperfine, Inc.
[{"type":"text","content":"CE Marking for the company’s portable MRI system with AI-powered imaging software demonstrates that the system complies with safety and performance requirements in the EU and provides the company optionality for future expansion beyond the current commercial focus\nGUILFORD, 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. 2017/745, commonly known as the Medical Device Regulation (MDR). EU MDR dictates the European distribution of medical devices, and compliance is mandatory to legally market and sell products in the EEA. Recent MDR mandates have raised the bar for manufacturers, requiring them to meet more stringent guidelines, and placing increased importance on a Clinical Evaluation Report (CER), a detailed analysis of clinical data about a medical device to support safety and performance. “Receiving CE marking for our portable MRI system with AI-powered imaging software is a significant achievement for our company and enables opportunities for future geographic expansion beyond our current commercial focus in the United States,” stated Maria Sainz, president and CEO of Hyperfine, Inc. “The standard for bringing medical devices to market in the EU has become significantly more stringent under the new MDR regulations, and we are proud to have accomplished compliance with these demanding standards.” For more information about the Swoop® Portable MR Imaging® System, please visit http://www.hyperfine.io. About Hyperfine, Inc. and the Swoop® Portable MR Imaging® SystemHyperfine, Inc. (NASDAQ: HYPR) is the groundbreaking medical technology company that created the Swoop® system, the world’s first FDA-cleared portable magnetic resonance imaging (MRI) system capable of providing neuroimaging at the point of care. The Swoop® system received initial U.S. Food and Drug Administration (FDA) clearance in 2020 as a bedside magnetic resonance imaging device for produ...