2024 Medtech FDA Approval Volume Trends Down

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    Medworld器械世界为您提供准确、及时、有效的医疗器械行业及医疗圈的市场动态，产品信息，技术进展等资讯。 来源 ：MDDI Checking the mid-year numbers, BTIG analysts recently reported on FDAs approval statistics, gleaming interesting trends in 510(k), PMA, De Novo, and Panel Track regulatory nods as well as the average time to approval. FDA approval rates Starting with 510(k) approvals, the numbers are trending down year-over-year (Y/Y) by 9.9%. According to FDA data from the first half of 2024 (1H24), 1,507 510(k)s have been approved through June. Assuming the trend continues for the full year — around 1545 submissions approved in 2H24 — equaling around 3052 for 2024, there will be a decrease of about 8.8% by year end. Through June, 13 original PMAs were approved, down from 22 same time last year. If 18 PMAs are then approved in 2H24 — 2H23s run rate —BTIG analysts said they can estimate around 31 will be approved for the full y ………………………………