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 ...

Health Canada released a draft guidance document on Tuesday to aid industry in determining whether the agency intends to regulate a software product as software as a medical device (SaMD). Health ...

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 ...

Navigating the SaMD regulatory pathways is one of the most complex yet important aspects of product development for medical technology startups. Startups in this field are required to meet local ...

Over the years, patient care delivery has transitioned from simple sense measurement (touch, smell, sight) to more complex devices and thereafter to smart software systems. This shift aims to improve ...

the future of healthcare is being written in code with AI transforming SaMD from a relatively niche technology into a linchpin of patient care. SaMD was still in its formative stage, with global ...

As AI and machine learning have become more important for the betterment of healthcare, the introduction of software as a medical device (SaMD) tools has shown promising results for doctors and ...

Dublin, Nov. 05, 2025 (GLOBE NEWSWIRE) -- The "Mobile Medical Device Apps and the FDA - Classification, Regulatory Requirements and Cybersecurity" training has been added to ResearchAndMarkets.com's ...