Sophisticated clinical software systems employed in specific health care services have graduated from being interfaces, operating systems, and subordinate tools that support physical medical devices ...

On January 12, 2021, the U.S. Food and Drug Administration (FDA) published the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan (action plan) in ...

The rise of AI in health care presents new challenges related to the patentability and regulation of AI-driven medical technologies. This article examines the 2024 guidelines from the U.S. Patent and ...

As the biopharma space gets more competitive and the days of blockbuster drugs seem further in the rearview, biopharma companies are investing in digital to find new and innovative ways to ...

There has been a surge in academic and business interest in software as a medical device (SaMD). It enables medical professionals to streamline existing medical practices and make innovative medical ...

Australia’s Therapeutic Goods Administration (TGA) released new guidance on the regulation of software as a medical device (SaMD), with plans to change SaMD classification. The guidance clarifies the ...

Australia’s Therapeutic Good Administration (TGA) released further guidance Wednesday on the regulation of software, including software as a medical device (SaMD), and a separate new guidance to ...

Kal Patel, MD, is CEO and Co-Founder of BrightInsight. He has over 20 years of experience in pharma, medtech and regulated digital health. Software as a Medical Device (SaMD) is changing how patients ...

Researchers from Tokyo Institute of Technology highlight the diverse and emerging nature of SaMD, its growth potential, and transformative impact on healthcare services, in a new study. There has been ...