FDA Resumes Pre-Submission Requests for Non-COVID-19 IVD Tests
Effective June 1, the agency is once more accepting pre-submission requests for all in vitro diagnostics, including non-COVID-19 tests.
BioMérieux and Sema4 Complete Strategic Acquisitions
Two of the biggest merger and acquisition-related deals that came down in May involved BioMérieux and Sema4
Already a member? Log in here
Collaboration Explores Humanoid Robot for Sequencing Sample Prep
Companies will explore LabDroid’s capacity to automate sample preparation workflows for long-read sequencing systems.
Already a member? Log in here
FY 2022 Q1 Could Be the Last Hurrah for the COVID Earnings Surge
Most diagnostics companies experienced modest, flat, or negative top-line revenue growth rates in the first quarter of 2022.
Already a member? Log in here
New EU IV Diagnostic Regulation Set to Roll Out
The IVDR will bring around 80 percent of in vitro diagnostic medical devices under the control of so-called Notified Bodies.