Two decades of growth and trends in the FDA authorization of digital medical devices

The regulatory environment for digital medical devices has rapidly changed in recent years as policymakers have worked to keep up with the evolving landscape of biomedical technologies. Despite the need for new regulatory efforts, existing data assets in the US are not capable of systematically tracking whether FDA-authorized medical devices have digital components, limiting regulators' ability to incorporate software-specific considerations into post-market surveillance activities and limiting other stakeholders' ability to understand the extent of digitization of different medical specialty areas and product categories. We pioneer a new application of text analysis, using records from tens of thousands of regulatory documents for newly authorized medical devices, to describe the digital transformation of the US medical device industry over the past two decades. We show that the number of medical devices with digital components has grown substantially over time, with meaningful heterogeneity across clinical specialties.