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FDA Adds Devices To Breakthrough Program, Cardiology Devices Still Out Front

 
• By Brian Bossetta

The US FDA has increased the number of devices cleared through its breakthrough program, which the agency established in 2015 to expedite access to products aimed at treating life-threatening and debilitating diseases.

The Food and Drug Administration has granted more than a thousand breakthrough device designations since the program was created in 2015.

As of 30 September, the agency has designated 1,041 devices as breakthrough

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