News We’re Watching – 20 January
Executive Summary
This new Medtech Insight feature compiles news briefs on a range of US regulatory and legal happenings. This week: Congressional criticism of ClinicalTrials.gov, new radiation device performance standards, clearance of a new sepsis test and two new device classifications.
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FDA Updates Slew Of Radiology Guidance Documents
The US Food and Drug Administration has released revised versions of six guidance documents to reflect new x-ray reporting requirements, among other changes.
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.
‘Core Pillars’ Of Safety And Innovation Take Center Stage In FDA Reports
The US FDA has issued a pair of reports focused on device safety and innovation. The reports describe recent steps the agency has taken to improve in the two areas, and what it plans to do next.