In an interview with Medtech Insight, Amy Abernethy, the US FDA’s outgoing second-in-command, threw her weight behind Janet Woodcock to be the agency’s next commissioner. News of Abernethy’s impending departure from the FDA and other stories topped our list of most-read Medtech Insight articles in March.
Janet Woodcock is the “right person” for the role of US Food and Drug Administration commissioner, the agency’s outgoing No. 2 official told Medtech Insight on 1 April.
“I feel very strongly about Janet Woodcock being the right person. I felt comfortable leaving my role because of the fact that Janet Woodcock is there,” said Amy Abernethy, who...
The FDA has stopped accepting data from two Chinese labs due to accuracy issues. Mid-Link and SDWH have been flagged for potentially falsified results and other misconduct. This decision, which follows months of discussions and warnings, emphasizes the FDA's commitment to ensuring data integrity in medical device submissions.
TRiCares presented data from the first-in-human study for its tricuspid valve replacement system – Topaz – at EuroPCR 2025 on 22 May.
Guardant Health introduces a new germline panel test to help guide cancer treatment, assess the risk of secondary cancers in patients and identify family members at risk of cancer.
Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.
