When things are working fine, it's easy to assume that software updates are unnecessary. But almost every device around you ...

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, ...

For almost a decade now, the smartphone and personal computer (PC) markets have been stuck in limbo. Refresh cycles for these devices have remained flat or even declined due to a lack of “must-have” ...

For many of us, we dread software updates to our favorite gadgets. Updates to a beloved gadget can leave us outraged, whether it’s because we’re frustrated with bugs or we’re Luddites and tech ...

Medical devices have to be designed so that people can use them easily and reliably. Human factors considerations have gained increased attention since the release of FDA's guidance document, Medical ...

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 ...