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 ...

Mario covers technology in health care, including FDA regulation of artificial intelligence; how Medicare pays for health tech; the use of AI in clinical care; mental health chatbots; and consumer ...

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 ...

In vitro diagnostics (IVDs) are a mainstay of modern medicine. People of all ages and their healthcare providers rely on these tests to determine the risk of a wide range of chronic and acute diseases ...

New regulations in the European Union aimed at modernizing the regulatory framework for medical devices are imposing several new compliance obligations on all medical device makers that want to market ...

This course provides a solid understanding of medical device regulation in the EU. It covers the history of medical device regulation in Europe and follows the regulatory requirements throughout the ...

The landscape of FDA medical device regulation has undergone a significant transformation. Today's regulatory environment presents both familiar challenges and entirely new complexities that device ...

Chapter 21: Preparing a Medical Device Submission Chapter 22: US Marketing Pathways: 510(k), De Novo, PMA, HUD/HDE, Breakthrough Devices Chapter 23: European Marketing Authorization and CE Marking ...

Since the 2017 publication of the medical device regulation (MDR) and the IVD regulation (IVDR), EU regulations for medical devices and IVDs have undergone a profound change. Manufacturers are now ...

Key opportunities include expanding knowledge on PRRC role integration, understanding MDR and IVDR compliance, leveraging third-party PRRC services, and enhancing Quality Management Systems. The ...