The MITRE corporation and MDIC have produced a manual on how to use cybersecurity threat modeling to make safer medical devices. The document asks four basic questions and provides helpful examples.

Regulators say that despite millions of HIV viral load monitoring tests on the market over the past 25 years, there has only been on class II recall for the products, which warrants easing their path to market.

Medtech Insight spoke with Sidley Austin attorneys about the future of medical device AI negligence litigation and what manufacturers can do to protect themselves.

A Walden University professor discussed various types of biases AI/ML developers need to take into consideration during the recent Xavier Health AI Summit. She noted a working group will produce a white paper laying out different types of biases to raise awareness.

The second 21^st Century Cures Act includes a provision to force the US Medicare agency to cover breakthrough medical devices for elderly patients, among other mandates.

While former FDA commissioner Califf was likely picked to head the agency again because he’s already been vetted, some Republicans may use his nomination as a political opportunity to deny Biden a win.