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Elizabeth Orr
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Latest From Elizabeth Orr
J&J Faces Fraud Claims From Merger With Surgical Robot Firm
Investors in surgical robotics company Auris say Johnson & Johnson failed to support the company per their merger agreement.
COVID-19: Newly Authorized Device From OraSure Subsidiary Allows At-Home Collection Of Saliva Samples
The device is among the first that does not require a health care professional to supervise the saliva sample-collection process.
FDA’s Biotin Interference Guidance Finalized
The document recommends testing for blood biotin levels as high as 3500 ng/mL, three times the maximum expected clinical concentration.
Merit Medical To Pay $18M To Settle Kickback Case
The US Department of Justice says the company provided advertising assistance and educational grants to health care providers that used its embolization devices.
Priority Lane: Guidances On Risky Devices, 510(k) Reform Top FDA’s To-Do List
The US FDA hopes to finalize or issue draft guidance documents on about 30 topics in fiscal year 2021.
Device Week, 16 October 2020 – FDA Issues 3 Guidance Docs
On this week’s podcast: The US FDA was busy with draft and final guidance documents this week, issuing three within 24 hours. The docs address disparate device industry concerns, ranging from of-the-moment issues like coronavirus test supplies, to more traditional concerns around device materials testing.