Views Differ On How Lab-Developed Tests Fit In FDA Companion Dx Guidance

Laboratory-developed tests are not explicitly mentioned in FDA’s 12-page draft guidance on companion diagnostics issued this summer, but the issue attracted significant attention in written comments in response to the document.

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International Reliance Gets UK MHRA OK In Drive For Agile Pre-Market Regulation – CE Marking Next

 
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The UK government’s response to MHRA public consultation on risk proportionate device routes to market and physical UKCA markings adds momentum to drive for modern, agile system. Another consultation in late 2025 will propose indefinite recognition of CE-marked devices in Great Britain.

Opinion: Catch A Fraudulent Scientist -- If You Can

 
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As AI tools make research fraud and résumé fraud easier than ever, life sciences companies need to take steps to protect themselves. Snedden Campbell CEO Ivor Campbell has some tips on successful strategies.

Medtronic’s MiniMed Expands EU Uses Of MiniMed 780G And Readies For US Expansion Amid Competition

 
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The timing aligns with Medtronic’s plan to spin off its $2.8bn diabetes unit, now named MiniMed. As a standalone entity, MiniMed will be more responsive to competition, regulatory shifts, and the diabetes technology needs of healthcare systems.