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, ...

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.

Software in the healthcare industry has come a long way over the past 20 years. Medical device companies, like most life sciences companies, were a bit hesitant to incorporate software and automation ...

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 ...

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The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations ...

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 ...

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 ...