Understanding AI/ML based Software as a Medical Device (SaMD)

As medical devices evolve into smart, connected, and scalable solutions, they are set to transform the healthcare experience across the value chain – for patients, care providers, and insurance companies. Technologies like cloud, mobility, extended reality, and artificial intelligence/machine learning are upending the conventional solution approaches and business models. AI/ML-based Software as a Medical Device (SaMD) offerings aim to improve diagnosis accuracy, therapeutic effectiveness, and monitoring efficiencies to improve patients' care. This essay discusses what SaMD is, what it isn't, and how AI/ML shapes these offerings for the digital age.

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ABOUT THE AUTHOR

Nirupam Kulkarni

Nirupam Kulkarni works as Product Manager focused on eInfochips' IoT and AI product and solution portfolio. He has 11 years of technology experience across IT and analytics consulting, market research, product management and digital partnerships.

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