Tandem Diabetes Care issued an urgent medical device correction to upgrade the software of its Tandem Mobi insulin pumps that ...

Software-based medical devices are integral to healthcare. To enter the marketplace, a company must successfully navigate and comply with applicable national and international regulatory requirements.

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 ...

Mobile device management creates a standard setting for corporate owned mobiles, tracks their location, and enforces security. Systems can also manage BYOD. Find out the best MDM system. Businesses ...

In medical-device software, an update isn’t just a new feature — it can directly affect patient safety. Every code change in a surgical-laser system must be fully traceable to its verification and ...

MPMN recently spoke with Kevin Fu, software expert and associate professor of computer science at the University of Massachusetts Amherst, about the current risks associated with medical device ...

This morning the FDA released two guidance documents relating to the regulation of various digital health software devices. The first is a draft guidance outlining categories of clinical decision ...

On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance ...

Bill McColl has 25+ years of experience as a senior producer and writer for TV, radio, and digital media leading teams of anchors, reporters, and editors in creating news broadcasts, covering some of ...

Software updates can be useful, but over time, many of us develop a habit of ignoring them altogether for the less-used devices or ones that we don't actively engage with. When things appear to be ...