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bioMérieux America CEO Talks Dx Reform Progress, Antibiotic Resistance

 
• By Sue Darcey

Stefan Willemsen, a top executive at diagnostics firm bioMérieux, has been working through AdvaMedDx with FDA, and with US House members to signal industry support for a bill to create a separate diagnostic regulatory framework at FDA. He spoke about that effort and explained how his firm’s products can be helpful in pinpointing cases of antibiotic resistance.

Exclusive interview Q&A KOI

The IVD test-kit industry is working closely with US FDA and Congress on legislation to reform the regulation of diagnostics. Stefan Willemsen, CEO of the US subsidiary of French diagnostics firm bioMérieux, spoke about that effort and the firm's focus on fighting antibiotic overuse in an interview with Medtech Insight.

Willemsen, along with other AdvaMedDx board members, met with lawmakers from the US House of Representatives and FDA device-center chief...

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23andMe Genetic Tests Among 12 New FDA Classifications

 
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A late-August batch of device classifications from the US FDA includes genetic tests from 23andMe, hand-held spinal surgery tools, and several IVDs.

Why EU Innovators Face Growing Barriers With EU Combination Product Regulation

 
• By Amanda Maxwell

Combination products are no longer fringe – they are the “new normal,” consultant Stephen O’Rourke told Medtech Insight. The EU has the expertise to handle the regulatory complexity, but only if connects the dots between silos. That’s the challenge, he said, and the opportunity.

UK MHRA Ready To Evolve Approach To In-House Manufactured Medtech

 
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FDA Panel Supports Dermal Fillers For Décolletage Use

 
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An FDA panel has endorsed the use of dermal fillers for décolletage, but warned of patient safety concerns. The filler can cause complications with future imaging and pregnancy or breastfeeding, panelists said. Regulatory measures and patient studies are recommended for better outcomes.

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Why EU Innovators Face Growing Barriers With EU Combination Product Regulation

 
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NeuroOne Prepares To Launch Trigeminal Nerve Ablation System

 
• By Elizabeth Orr

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Warning Letters - July 2025

The US FDA posted three warning letters in July, covering medical supply kits, wearables and orthopedics.