FDA Approps Amendment Targets Chief Counsel Troy

FDA Chief Counsel Daniel Troy's intervention in civil suits on behalf of device maker Pacesetter and several drug firms has drawn a rebuke from House legislators in the form of funding cuts

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Biotech Leader Predicts Delays On Device Approvals As FDA Makes Life-Saving Drugs Sole Priority

 

Nawal Ouzren, Sensorion CEO and director, shared the latest industry reaction to US FDA layoffs at the McDermott Will & Emery European Health and Life Sciences Symposium in Paris.

IMDRF Offers Granular Playbook On ‘Regulatory Reliance’ Program Development And Implementation

 
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International device regulatory group IMDRF has issued a new playbook on “regulatory reliance,” which allows regulators to make use of assessments performed by trusted regulatory partners. The document is the first to offer a detailed guide on developing and implementing these agreements.

LSI 2025: Egg Medical Builds ‘Nests’ Around Interventional Cardiologists To Protect Against Scatter Radiation

 
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Egg Medical is ramping up efforts to expand international sales of its EggNest scatter radiation protection system to shield X-ray procedure room staff without disrupting workflow. Medtech Insight sat down with Bob Wilson, Egg Medical’s CEO, to discuss the various EggNest systems, marketing opportunities and the competitive landscape.