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.”
Source: Company Press Release
