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EU Unanimously Votes to Delay MDR by 1 Year

EU Unanimously Votes to Delay MDR by 1 Year

In a unanimous decision on Wednesday (4/22), the European Union has decided to push back the amendment to Medical Device Regulation by one year amidst the COVID-19 pandemic. This extra time will allow more time to ensure the functionality and design of...
FDA Authorizes First At-Home COVID-19 Testing Kits

FDA Authorizes First At-Home COVID-19 Testing Kits

Yesterday (4/21) the FDA announced EUA for at-home testing kits from LabCorp. These nasal swab tests were previously authorized in mid-March by the FDA, however only for medical professionals to use. Stephen Hahn, FDA Commissioner, released in a statement that...