The Software as a Medical Device (SaMD) market is experiencing explosive growth. These software applications, designed for medical purposes from diagnosis and prevention to monitoring, treatment, and even alleviation of disease, are able to fill gaps in an overburdened, understaffed healthcare system.
Galen Data reported that the global market value for SaMD was $1.2 billion in 2022. It is expected to increase to $5.4 billion by 2032, with a compound annual growth rate (CAGR) of 16.7%. This growth is driven by several factors, including advancements in artificial intelligence (AI) and machine learning (ML), increased adoption of cloud computing, focus on personalized medicine, and the rise of the female healthcare consumer.
As of April 2024, we have been able to find and categorize 530 FDA-cleared SaMD products across 18 categories, including three products we’ve led research and design for here at Guidea. This list is, in part, from the FDA’s list of AI enabled medical devices, and also includes FDA-cleared digital therapeutics (DTx) and other FDA-cleared SaMD that is not AI enabled.
The most prominent category for SaMD innovation and clearance is:
Other active categories include:
While we can’t say for certain what will be cleared next, we can explore the pipeline. We took a deep dive into the ARPA-H Nationwide Health Innovation Network, the USPTO, and ClinicalTrials.gov to see the Request for Solutions (RFS), grant funded projects, patents filed, and clinical trials. Check out our predictions for The Future of SaMD: A Glimpse of What's To Come.
Guidea partners with leading biopharma, life science, MedTech, and healthcare companies to design and validate products that measurably improve people’s health. Our repeatable process for innovation provides a reliable path to deliver effective and engaging products for patients, providers, payers, and employers. Contact us to learn more about our work with DTx and SaMD pioneers: WellDoc, Somryst, and Cognoa.
Sources:
MedTech Intelligence: FDA-Cleared SaMD by the Numbers
FDA Publishes Updated list Of 521 Authorized AI Enabled Medical Devices
UFDA: Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices
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