Page 3 - Device Software Functions News Today

The agency says it is proposing a science-based approach to requirements for medical devices powered by artificial intelligence and machine learning that would help deploy new devices faster.

This article reviews the existing FDA programs impacting artificial intelligence (AI) / machine learning (ML) technologies in medtech, as well as the...

Advisers will consider the latest data on the safety and efficacy of mpox vaccinations, updates on the flu season and vaccination and pneumococcal vaccines.

Consumer demand for health and wellness products has seen vast growth in recent years. The COVID-19 pandemic and its aftermath has also resulted in broader avenues through which consumers...

Medtech companies should have a team of FDA advisors at the ready to develop and implement pre- and post-market strategies, prevent and resolve pre- or post-market issues and guide lifecycle management

Software that is qualified as an in vitro diagnostic medical device (known as SaMD IVD) is affected by the same requirements as other medical...

Software with a medical intended use can be embedded as part of a medical device, or it can also be considered a medical device by itself and...

The convergence of wearable technology and artificial intelligence systems that can analyze data in real time to optimize health care delivery is generating a new wave of products that raise novel regulatory, business...

The convergence of wearable technology and artificial intelligence systems that can analyze data in real time to optimize health care delivery is generating a new wave of products that...

If you are developing a digital health or software product, it may contain software functions that are considered devices under the Federal Food, Drug, and Cosmetic Act and subject to FDA oversight. The FDA developed the Digital Health Policy Navigator as a guide.