FDA's AI Medical Device List: Stats, Trends & Regulation
Learn about the FDA's AI/ML medical device tracker. We analyze authorization trends, key statistics by specialty, and the 510(k) regulatory pathway for approval
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Articles tagged with “software-as-a-medical-device”
AI Medical Devices: 2025 Status, Regulation & Challenges
Analysis of AI medical devices in 2025. Learn about market growth, 950+ FDA-cleared devices, new regulations like the EU AI Act, and key clinical challenges.
Digital Therapeutics Market: 2025 Analysis & Growth Trends
Explore the digital therapeutics (DTx) market. This analysis covers market size, growth trends, key drivers, regulatory frameworks, and future outlook for 2025.
An Introduction to Software as a Medical Device (SaMD)
Learn the official definition of Software as a Medical Device (SaMD) from the IMDRF. Understand its scope as standalone software and its regulatory status.