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Amendments To Breakthrough Device Coverage Act Push Bill Out Of House Ways And Means Committee

 
• By Hannah Daniel

The amendment introduced to the Ensuring Patient Access to Critical Breakthrough Products Act in the Ways and Means committee markup of helped usher the legislation to a passing vote.

• Source: Shutterstock

The Ensuring Patient Access to Critical Breakthrough Products Act of 2024 (HR1691) was approved by the US House Committee on Ways & Means on 27 June, supported by an amendment that tightened the criteria for breakthrough devices to be covered by the pathway.

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Medtech Strategy Must Be Priority, German Diagnostics Firms Tell Government

 
• By Ashley Yeo

Germany’s incoming coalition government has reacted positively to industry’s calls for a dedicated medtech strategy to boost economic growth. Faster digitization, lower energy costs and “IVDR 2.0” are also on the in vitro diagnostic industry’s agenda.

FDA Reverses Course, Allows Some Telework For Reviewers

 
• By Derrick Gingery

The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.

Opportunity For Medtech To Contribute To EU Cybersecurity Recommendations

 
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The deadline for comments is 30 June 2025

Dexcom Wins FDA Nod For 15-Day G7 CGM, Closing Gap With Abbott’s 14-Day FreeStyle Libre

 
• By Marion Webb

Dexcom announced it received US clearance for its 15-day CGM, which has a MARD of 8.0% and is expected to launch in the second half of 2025 to allow for integration with insulin pumps.

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Birmingham City University Develops New Defense Mechanism Against Cyberattacks On AI Systems

 
• By Natasha Barrow

AI systems used in healthcare are vulnerable to adversarial cyberattacks, which are a growing concern, said Atif Azad, a professor of AI at Birmingham City University. Azad’s research group has developed a method that trains AI to become more resilient to cyber threats through the use of random image adjustments.

Opportunity For Medtech To Contribute To EU Cybersecurity Recommendations

 
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Dexcom Wins FDA Nod For 15-Day G7 CGM, Closing Gap With Abbott’s 14-Day FreeStyle Libre

 
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