Introduction  In the rapidly evolving field of healthcare, software has become an integral component. Recently, an update on the “Software and Artificial Intelligence (AI) as a Medical Device” guidance was published by the Medicines & Healthcare products Regulatory Agency (MHRA) on the U.K. government website. The MHRA is the agency responsible for the regulation this emerging field of medical devices in the U.K.  Software’s Role and Classification in Healthcare  Software, ranging from diagnostic tools to AI-driven analysis, plays a pivotal role in healthcare. The MHRA class ..read more

Introduction  The intersection of artificial intelligence and machine learning (AI/ML) with healthcare is nothing short of revolutionary. Yet, this fusion of technology and medicine brings forth a labyrinthine regulatory landscape. While FDA decisions offer a glimpse into what’s possible, they also highlight the challenges of bringing AI/ML medical devices to market. This article aims to describe the most up-to-date landscape for the top 10 markets for AI/ML-enabled medical devices that have received a final decision from the FDA.  Dataset Description  In our descriptive analysi ..read more

The integration of artificial intelligence (AI) and machine learning (ML) in medical devices represents a turning point in healthcare innovation. The U.S. Food and Drug Administration (FDA) is at the forefront of this revolution, establishing a robust regulatory framework to harness the potential of AI/ML while safeguarding patient health. This blog post explores the transformative impact of AI/ML in healthcare and the FDA’s multifaceted strategy to regulate these advancements effectively.  The Transformative Role of AI and ML in Healthcare  AI and ML are more than futuristic buzzwor ..read more

In our previous blog post “The EU’s AI Act and Medical Device Research,” we outlined the proposed Artificial Intelligence Act (AI Act) and three potential challenges that it currently poses for developers of AI-enabled medical devices. The topic of this blog post explores another key document published by the European Commission “White Paper On Artificial Intelligence – A European approach to excellence and trust,” which outlines a comprehensive strategy for AI in Europe, focusing on balancing technological advancements with ethical considerations and trust. This blog concludes by offering cri ..read more

Artificial intelligence (AI) has become an integral part of our daily lives, influencing everything from personal devices to large-scale industrial processes. It has also permeated healthcare, where it plays a pivotal role in areas such as diagnostics, patient care, and medical devices. Recognizing AI’s profound impact and the need for its regulation, the European Commission in the European Union (EU) has taken a bold first step: proposing the Artificial Intelligence Act (AI Act). Released in April 2021, the AI Act is a comprehensive legal framework aimed at ensuring that AI systems and applic ..read more

Site selection is stressful. It’s tricky to find and choose research sites that both meet your clinical trial’s qualifications and have the characteristics necessary for success — unless you use data from the Centers for Medicare & Medicaid Services (CMS) to enhance site feasibility by validating a potential site’s applicable patient population size and its ability to recruit research participants.   CMS provides data on Medicare, Medicaid, and the Children’s Health Insurance Program beneficiaries, which, according to Ha & Vermeersch, cover more than one-third of the U.S. pop ..read more

The FDA has issued the Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance that includes recommendations to industry regarding cybersecurity device design, labeling, and the documentation that the FDA recommends be included in premarket submissions for devices with cybersecurity risk. These recommendations are intended to promote consistency, facilitate efficient premarket review, and help ensure that marketed medical devices are sufficiently resilient to cybersecurity threats. This document supersedes the final guidance “Content of Pre ..read more

Pursuing market approval for medical devices that will be used in both the EU and the U.S. is more complex than ever due to the transition from the Medical Device Directive (MDD) to the more stringent demands of the Medical Device Regulation (MDR) in Europe. In addition, data and documentation demands can differ greatly depending upon the region in which one is operating. Yet significant opportunities exist to identify overlaps in clinical data across multiple geographies and capitalize on them, resulting in pre- and post-market efficiencies that can accelerate timelines, trim budgets, and opt ..read more

The transition from the In Vitro Diagnostic Medical Device Directive (IVDD) to the In Vitro Diagnostic Medical Device Regulation (IVDR) is not something to be ignored. Some estimates say that 85% of IVDs self-certifying under IVDD regulation will now be required to submit documentation according to IVDR.  Here are three of the biggest changes between IVDD and IVDR and how they might impact your IVD success.   IVDR Guidance on Risk Reclassification   First and foremost, IVDR represents a whole new level of regulation when compared to IVDD. The latest developments in the EU a ..read more

Famous railroad executive Alfred Perlman once wrote, “After you’ve done a thing the same way for two years, look it over carefully. After five years, look at it with suspicion.  And after ten years, throw it away and start all over.” Though perhaps uttered in hyperbole, Perlman’s words speak directly to the heart of evolution in any industry. Change is always happening, and those organizations that evolve alongside their industry will never miss a beat.  This generalization is especially suitable for software as a medical device (SaMD, a term generally used outside the EU) and medical dev ..read more