Many medical device companies develop software using a traditional waterfall methodology in which each step is taken in sequence: requirements, design, implementation, verification, and validation ...

FDA revised guidance documents for low-risk wellness products and clinical decision software, clarifying regulatory ...

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 ...

Software as a Medical Device (SaMD) has reshaped the technological, regulatory, and clinical landscape of modern healthcare. Yet regulatory approaches remain anchored to assumptions grounded in ...

For SLAS US 2023, we speak to Guy Starbuck, one of the co-founders at AIQ Global, about how we can utilize AI technology to bring new medical devices to market. Please could you introduce yourself and ...

In 2023, the MedTech custom medical software development market will continue growing with projected revenue of $579.40 billion, keeping developers busy. New solutions provide companies with the tools ...

Medical devices have played a critical role in raising the standards of healthcare delivery. The COVID-19 pandemic underscored clinical medicine’s dependence on devices ranging from diagnostic test ...

Software is increasingly used as a medical device, transforming the healthcare industry with the goal of improving patient outcomes. However, developing software as a medical device involves ...

Artificial intelligence (AI) is no longer the future of healthcare—it’s already here. AI-driven medical devices are diagnosing diseases faster than doctors, guiding surgical procedures with precision ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

Ransomware attacks on the healthcare sector surged by 30 percent in 2025, frequently disrupting operational technology and medical devices. FDA Section 524B mandates that manufacturers provide a ...

“Don’t fear the Reaper,” the rock band Blue Öyster Cult famously advised. For many digital health companies, the Food and Drug Administration’s recently revised guidances affecting the classification ...