BCG&UCLA：2025年人工智能与机器学习在医疗科技领域的崛起研究报告（英文版）

The age of AI/ML in the medtech industry has arrived, with annual authorizations ballooning from single digits in the early part of the past decade to a cumulative 1,016 by Q3 2024, the latest reported data. (See Exhibit 1.) Although they still account for just a small fraction of annual 510(k) clearances, AI/ML-enabled devices are carving out an important niche in the sector. Since September 2023, a dozen De Novo AI/ML-enabled devices have received FDA approval—versus only 20 during the enti