FDA Clears ConforMIS, Inc.’s Knee Replacement System

FDA Clears ConforMIS, Inc.’s Knee Replacement System

The U.S. Food and Drug Administration (FDA) has granted ConforMIS Inc. 510(k) clearance for its Identity Imprint™ Knee Replacement System. Available in both posterior stabilized (PS) and cruciate retaining (CR) versions, the system expands the range of options for...
EU Unanimously Votes to Delay EU MDR by 1 Year

EU Unanimously Votes to Delay EU MDR by 1 Year

In a unanimous decision on Wednesday (4/22), the European Union has decided to push back the amendment to the EU MDR by one year amidst the COVID-19 pandemic. This extra time will allow more time to ensure the functionality and design of the new system, while also...