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Califf Hires New US FDA Senior Advisor, But Duties Seem Vague

 
• By Derrick Gingery

As a senior advisor for chronic disease, Haider Warraich will help shape policy and product development in several areas, but the FDA provided few details on the cardiologist’s new duties.

FDA building with sign
New FDA senior advisor Haider Warraich's pain expertise may be useful in the agency's fight against opioid abuse. • Source: Shutterstock

Haider Warraich, a cardiologist and author, has been named a Senior Advisor for Chronic Disease to the US Food and Drug Administration Commissioner, although the duties of his new position seem somewhat unclear.

Warraich, an attending cardiologist at Brigham and Women’s Hospital in Boston and assistant professor at Harvard Medical School, wrote in...

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• By Amanda Maxwell

The EU’s Artificial Intelligence Act, which entered into force on 1 August 2024, is already facing turbulence.

Medtech Giants Brace for Tariffs Impact: Responses Range From Financial To Philosophical

 
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Final Curtain For LDTs? FDA Will Not Appeal District Court Decision To Vacate Final Rule

 
• By Brian Bossetta

The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.

EU Finalizes Framework For Joint Clinical Assessments Of High-Risk Devices

 
• By Amanda Maxwell

Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.

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Global Medtech Guidance Tracker: May 2025

 
• By Vibha Sharma

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.

More Haste Less Pace? Challenging The ‘Early As Possible’ Principle In Medtech Innovation

 
• By Stuart Grant

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Guardant’s Multi-Cancer Detection Test Granted FDA Breakthrough Device Designation

 
• By Natasha Barrow

Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.