(Reuters) -Federal regulators have asked Novavax to complete an additional clinical trial on its COVID-19 vaccine after ...

A new randomized study could cost Novavax tens of millions of dollars, vaccine experts say ...

After 20 percent of the agency’s work force was cut, federal health officials have decided to bring back some experts and ...

LEM Surgical announced that it received FDA 510(k) clearance for its Dynamis robotic surgical system for hard tissue surgery.

DHA R&D-MRDC researchers are applying the latest regulatory guidance related to AI to better carry out their mission to develop life-saving medicines.

Tim Boreham sharpens his knifes to look under the hood at cardiac pacing device innovator EBR Systems after its US FDA ...

Short Summary The EU, UK, and USA each have distinct and evolving regulatory systems for medicines and medical devices, involving strict approval, surveillance, and market access requirements managed ...

The tech giant's Damo Academy secured a "breakthrough device" designation from the US regulator for its pancreatic cancer-detecting AI model, Damo Panda Alibaba Group Holding's research arm, Damo ...

The question is not whether AI will transform healthcare; it’s whether regulators can keep pace with that transformation.

EBR designed its WiSE system to significantly expand the population of patients who could benefit from CRT. The leadless ...

The rise of AI in health care presents new challenges related to the patentability and regulation of AI-driven medical ...