News We're Watching – 27 January
Executive Summary
This feature compiles news briefs on a range of US regulatory and legal happenings. This week: Medtronic seeks HeartWare batteries; companies sign health equity pledge; insulin dosing app cleared; recall on field decontamination kits; and the renewal of an FDA panel.
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Small Sterilization Companies Poised To Meet EtO Emissions Goals On Time
Small sterilizers told Medtech Insight that they were ready for the EPA’s controversial EtO emissions rule, while community advocates expressed concerns.
Addition to Quest Alzheimer's Suite Looks For Biomarker P-Tau217
The test is being integrated into Quest’s AD-Detect portfolio for assessing the risk of Alzheimer’s. It is the third p-tau217 test to make news this month, after new breakthrough designations for Quanterix and Roche and Eli Lilly.
CDS Final Guidance Draws More Criticism, This Time From Congress
Senator Bill Cassidy says FDA “disregarded” Congressional intent by expanding its authority to regulate clinical decision support software.