For manufacturers of software-containing devices, a clear understanding of all relevant standards is crucial. This article takes a close look at the past, present, and future state of those standards.

Medical apps, treatment planning software, and even firmware for ultrasound devices: software is legally classified as a medical device if it is used for medical purposes. This includes diagnosing, ...

In anticipation of FDA’s virtual public workshop on transparency of artificial intelligence/machine learning (AI/ML)-enabled medical devices scheduled for October 14, 2021, we will be posting a series ...

The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations ...

Kimberlee Leonard has 22 years of experience as a freelance writer. Her work has been featured on US News and World Report, Business.com and Fit Small Business. She brings practical experience as a ...