Software as a medical device (SaMD)
SaMD is a piece of software designed to treat, diagnose, and/or manage a patient’s medical condition.
It is often paired with a medical device to analyse data and detect/diagnose transient events that may otherwise go undetected by a periodic physical exam. As a result of technological advances, SaMD has been increasing in volume and prominence throughout our industry to improve patient diagnosis, access, and treatment.
SaMD adds a crucial dimension to patient treatment by enhancing patient and health care provider access to real-time health information, facilitating earlier diagnosis and access to a greater variety of treatment options.
SaMD devices are becoming increasingly patient-centric, incorporating usage models that provide continuous patient data and enable early interventions. When combining daily data monitoring by clinicians with advanced software algorithms that detect early signs of health deterioration, these devices allow for more proactive and timely care.
To learn more about Medical Device & Diagnostics Research and clinical investigations of SaMD digital therapeutics, please contact us.
Developing AI in software as a medical device
Model and data selection best practices
This whitepaper, the second in our series of three, is intended for medical device developers already exploring the possibilities of using AI within future products. It takes stock of the current landscape in the US for AI-enabled medical devices and offers guidance for scientists and engineers considering developing AI-enabled medical devices.
Decoding AI in software as a medical device (SaMD)
Regulatory insights and market strategies
This whitepaper provides a starting point for medical device researchers considering use of AI in SaMDs. Understanding the FDA regulatory requirements and guidance on submissions can enable medical device researchers to plan their route to market and avoid potential obstacles on the way.
Clinical strategies to optimise software as a medical device (SaMD) for treating mental health
Mental health disorders affect millions, and with increasing diagnoses, the demand for new, accessible treatments is growing. In this whitepaper, we examine how SaMD, particularly through digital therapeutics, is providing new solutions for mental health management.
Software as a medical device (SaMD)
Blog: Understanding FDA regulations for AI in software as a medical device
The first AI-enabled device received FDA approval in 1995, but it wasn’t until 2015 that it became more widely adopted. Between 2015 and March 2025 the FDA approved more than 1,000 AI-enabled devices. In this blog we look at regulatory considerations for AI in software as a medical device (SaMD).
Media article: Clinical strategies to optimize software as a medical device to treat mental health
Every clinical trial has challenges, but trials researching SaMD use to treat mental health disorders have unique ethical, regulatory and technical ones. In this Applied Clinical Trials article we explore the implications of a vulnerable patient population and new technology.
Case study: Eliminating enrolment delays to bring an AI-enabled SaMD to market
A medical device developer faced clinical evaluation timeline delays due to under-enrolment. Discover how the collaborative partnership between the sponsor and ICON’s Medical Device & Diagnostics Research team steered the study from patient enrolment to FDA submission and approval.