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More But Slower Medtech Approvals

 
• By Elizabeth Cairns

If the pace is maintained in the second half of the year, 2023 could see the most US device approvals in a decade.

Fast slow tortoise hare
Fast slow tortoise hare • Source: www.evaluate.com

The US Food and Drug Administration's Center for Devices and Radiological Health seems to have pulled its socks up. The medical device regulator granted approval or clearance to 45 innovative products in the first half of 2023 – only one less than in the entirety of 2022.

The caveat is that these approvals were slower. The agency took an average of nearly three years to grant the 22 approvals for high-risk devices, a much longer average period than in prior years

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