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Real-World Evidence Deemed Essential For Breakthrough Designations

 
• By Brian Bossetta

A panel of experts in the health care and medical device industries discussed the fate of the Medicare Coverage for Innovative Technology (MCIT) rule during AdvaMed’s annual Medtech Conference.

RWE DATA FLASHDRIVE.
• Source: Alamy

There’s no clear path forward for Medicare coverage of innovative devices, a panel of experts in the health care and medical device industries said during AdvaMed’s annual Medtech Conference.

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Secretary Kennedy’s FDA Visit Included CDRH Stop, Speech Warning Of ‘Agency Capture’

 
• By Sue Sutter

HHS Secretary Robert F. Kennedy Jr. urged FDA staff to resist the “deep state” and “crony capitalism,” and focus on improving the health of America’s children. “You're not here to take orders,” he said and urged FDA staff to speak up if they see wrongdoing.

FDA Reverses Course, Allows Some Telework For Reviewers

 
• By Derrick Gingery

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• By Amanda Maxwell

The deadline for comments is 30 June 2025

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• By Amanda Maxwell

Well over 200 European standards need harmonizing under the MDR. But only around 12% have been attended to so far.

More from Policy & Regulation

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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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.