Editor’s Note: We are excited to announce that this article is the first of a series addressing Software as a Medical Device and the issues that plague digital health companies, investors, clinicians ...

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PCCPs allow device manufacturers to implement preapproved modifications to their devices in lieu of obtaining separate authorizations for each significant change prior to implementation. A PCCP ...

The latest update to the Federal Drug Administration (FDA) for medical device cybersecurity mandates the development of a software bill of materials (SBOM). This provision can be a significant ...

Connected medical devices improve patient care but introduce severe cybersecurity risks that require stringent regulatory ...

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 ...

Over the years, medical devices have become increasingly dependent on software. They have evolved from the use of a metronome circuit for early cardiac pacemakers to functions that include ...

While Illumina has yet to receive any reports indicating this vulnerability has been exploited, according to a letter to healthcare providers from the U.S. Food and Drug Administration, bad actors ...

Makers of smart devices that fail to disclose how long they will support their products with software updates may be breaking the Magnuson Moss Warranty Act, the Federal Trade Commission (FTC) warned ...

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 ...

Self-driving cars are no longer a futuristic concept; they're on the roads today. One might have passed you on the way to work. But what if you don't want to buy a brand-new car to experience this ...