As connected medical devices become more commonplace, device manufacturers should prepare for helpful hacking and consider how to address potential recalls that may arise. Kevin Pollack It's difficult ...

Medtronic’s introduction of its Artificial Intelligence (AI) enabled colonoscopy system turned a few heads at JP Morgan this year. J&J’s surgical partnership with NVIDIA is now building on the earlier ...

The Food and Drug Administration designates as “breakthrough” technologies certain drugs and devices. This designation helps expedite the development and review of therapies intended to treat serious ...

In conversations about medical device cybersecurity, attention focuses on the Food and Drug Administration’s (FDA) rules and guidelines. With a refresh in 2023 that emphasized new protocols for ...

Evolving regulatory requirements and AI capabilities are reshaping quality management in the medical device industry. With increasing focus on compliance, traceability and patient safety, ...

AI is evolving healthcare. While it's a powerful tool to support everything from automation to predictive analysis, it also brings about pause for its inherent risks. Simply put, AI is a cybersecurity ...

Every year there are 150,000 incidents where Australians require hospital treatment because medical devices that are meant to ...