Global Medtech Guidance Tracker: October 2024

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.

Guidance word in red keyboard buttons

Fifty-one guidance documents on medical devices and diagnostics issued by regulatory authorities from around the world were added to Medtech Insight’s Guidance Tracker in the past month.

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HIMSS 2025: Interview with Aneesh Chopra, Arcadia’s Chief Strategy Officer, About The Future Of Health Data, Interoperability, AI

 
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Medtech Insight sat down with Arcadia's chief strategy officer Aneesh Chopra to discuss interoperability, industry standards and the future of health care data and AI.

Global Medtech Guidance Tracker: February 2025

 
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 30 documents have been posted on the tracker since its last update.

AI Bias Page, Health Equity Discussion Paper Back On FDA Site

 

Two US FDA device center websites have been restored under a restraining order. The pages now carry a disclaimer alleging they include "extremely inaccurate" content about gender; however, neither site includes any substantive discussion of trans issues.

UK HTA Body NICE Promises Positive Shake-Up For Medtech Users

 
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Medtechs watch with interest as NICE, a long-standing component of market access for innovative technologies in the National Health Service, vows to get to grips with technology programs that often miss the target for developers of groundbreaking solutions.

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New FDA Commissioner Makary Could Face Turbulent Waters

 

Stakeholders are pleading for newly confirmed FDA Commissioner Martin Makary to stand up for the agency's high scientific standards and staff as he begins his term.

Research Finds Benefit From DME Suppliers For People Living With Diabetes

 
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People living with diabetes who receive continuous glucose monitors (CGMs) through medical supply firms show higher compliance, lower costs of care, and fewer hospitalizations after one year than those who use pharmacies, a new study shows.

EU Commissioner: Medtech Regulations Assessment To Wrap Up by End 2025

 

Pediatric devices and IVDs are to be a priority. And the European Health Data Space regulation is seen as critical in supporting digital technologies and AI in transforming care.