The healthcare industry has always relied on new technology to drive it forward and improve the care that patients get. From the invention of things like the magnifying glass and the stethoscope ...

FDA will publish draft guidance on its Predetermined Change Control Plan in 2021 and host a public workshop on transparency requirements around AI/ML-based devices. FDA plans to pilot Real-World ...

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 ...

On November 4, 2021, FDA released a draft guidance for public comment entitled “Content of Premarket Submissions for Device Software Functions” (the “2021 Draft Guidance”). In its final form, this ...

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 ...

Software in the healthcare industry has come a long way over the past 20 years. Medical device companies, like most life sciences companies, were a bit hesitant to incorporate software and automation ...

The US Food and Drug Administration (FDA) has released draft guidance for sponsors outlining its thinking about the documentation needed to support the agency’s evaluation of device software functions ...

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 ...

November 14, 2022 - Technology and science have the potential to fundamentally transform the health care industry. As artificial intelligence and machine learning advance, medical devices will detect ...

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 ...