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.

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.

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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.

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