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FDA Doc Bemoans ‘Dearth’ Of Pediatric Devices, Says Real-World Data Could ‘Make A Difference’

 
• By Shawn M. Schmitt

Vasum Peiris, an MD and the US agency’s chief medical officer for pediatrics and special populations, is worried about the lack of innovative devices for young people. But he’s hopeful that real-world evidence could turn that around.

Back to school building blocks on stacked books pencil and ruler.

The US Food and Drug Administration’s top doctor for pediatric medical devices is concerned that more products aren’t being designed with patients 22 and younger in mind.

“One of the fundamental issues that we’re dealing with from a public health standpoint is a dearth of medical devices...

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UK Healthtech Center Of Excellence Given Key MHRA Digital Regulation Role

 
• By Ashley Yeo

Ahead of the 11 June UK spending review and its anticipated funding uplift for healthcare and life sciences, the MHRA announced an expansion of its digital expertise by creating a dedicated hub in Leeds, a renowned center of medtech excellence.

Where Do Questions Surrounding The EU’s AI Act Leave The Medtech Industry?

 
• 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

 
• By Marion Webb, Shubham Singh, and Nancy Pham

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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.

More from Policy & Regulation

FDA Drops Package Labeling Guidance For Hernia Mesh Manufacturers

 
• By Brian Bossetta

The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.

Medtechs Wait For Dividend As UK Spending Review Prioritizes Healthcare And NHS

 
• By Ashley Yeo

Increased support for NHS services and delivery infrastructure announced in the 11 June government spending review by chancellor of the exchequer Rachel Reeves could boost inward investment and offer new market opportunities for medtechs.

UK Healthtech Center Of Excellence Given Key MHRA Digital Regulation Role

 
• By Ashley Yeo

Ahead of the 11 June UK spending review and its anticipated funding uplift for healthcare and life sciences, the MHRA announced an expansion of its digital expertise by creating a dedicated hub in Leeds, a renowned center of medtech excellence.