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 ...

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 ...

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 ...

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 ...

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 ...

Software as a Medical Devices (SaMD) Market Overview: DataM Intelligence published a business research report on the Software as a Medical Devices (SaMD) Market by Device Type, By Application, By ...

Advancements in the medical device space are increasingly driven by integrations of software, oftentimes as the fruit of the symbiosis between engineers at software development firms working with ...

Enlil has entered into a strategic partnership with Interlynk, an enterprise product security platform specializing in software and AI supply chain cybersecurity. Together, they’re delivering an ...