APPROVALS ANALYSIS: Big Month For Cardio Devices, But Down Overall

April was a slow month for medical device approvals, with just 46 recorded for the month on Clinica’s Medical Devices Approvals Tracker, but it was the biggest month for PMAs and PMA supplements approved by the US FDA in more than a year.

The 46 approvals on the Tracker for April include 12 original PMAs or noteworthy PMA supplements, 19 510(k), de novo, or other FDA clearances, 14 CE marks, and one approval outside the US or Europe. Mostly due to the decline in 510(k)s and approvals outside the US or Europe, the total number for April was down sharply from the 57 total approvals in