Roche ASR Marketing Approach For AmpliChip Microarray Draws FDA Scrutiny

CDRH is asserting that Roche's AmpliChip CYP450 microarray, launched June 25, does not qualify as an analyte-specific reagent, and may require premarket review

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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.

Expert Panels Remain Tough On Manufacturers And Their Notified Bodies

 

The EU’s extra layer of checks on clinical evidence is proving a difficult, and sometimes humiliating process, for many device companies whose products have come under the spotlight.