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FDA Breakthrough Device Program Nears 800 Designations

 
• By Elizabeth Orr

Almost 800 devices have been granted priority status through the US FDA’s breakthrough devices program, the agency announced this week. But device clearance numbers continue to lag, with only 67 granted as of 31 March.

Brain rocket bursting through horizontal line
• Source: Shutterstock

New data from the US Food and Drug Administration shows the growth of its breakthrough devices program, but may raise questions as to how effective the program is in getting innovative devices to market.

The breakthrough devices program, which launched as the expedited access pathway in 2015, grants regulatory advantages to some innovative devices...

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Medical Device Recalls Down In Q1 For Lowest Quarterly Count In 3 Years. But Will It Last?

 
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German Health Researchers Prep for Possible Disruptions to PubMed, ClinicalTrials.gov

 
• By Elizabeth Orr and Francesca Bruce

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