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 ...

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 ...

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 ...

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 ...

The US Food and Drug Administration (FDA) requested feedback Tuesday on a new discussion paper that proposes applying a “focused review” approach to premarket assessments of software as a medical ...

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 ...

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 ...

Artificial intelligence/machine learning (AI/ML)-enabled medical devices (AI/ML devices, hereafter) offer exciting new opportunities to continue the advancement of healthcare. These innovative ...

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 ...

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 ...