Michelle Tarver, who will officially replace longtime CDRH leader Jeff Shuren, emphasized the agency’s focus on patients in comments last week.

Advamed’s largest — featured an appearance by the device center’s new acting director and sessions on AI, clinical trial diversity and the FDA’s contentious LDT rule.

Johnson & Johnson, Abbott and Intuitive Surgical made a mixed start to earnings season last week. The second wave of the medtech industry’s latest earnings season arrives this week, with Boston ...

The AI Innovation Lab is designed to to accelerate early concept artificial intelligence projects including tools to predict the recurrence of cancer and automate image interpretation.

Laboratories face a series of upcoming deadlines to comply with stricter FDA oversight of in-house tests. Here are five strategies labs can take to be ready.

Findings from a new survey of executives in MedTech companies reveal that the majority of their revenues come through contracts with healthcare facilities, integrated delivery networks (IDNs) and ...

The FDA’s Suzanne Schwartz said at The Medtech Conference that addressing legacy devices is a “work in progress” and a problem regulators and industry need to work on together.

After expanding in global markets, the U.K.-based company will challenge Intuitive Surgical in the U.S., starting with gallbladder removal procedures.

Alongside immunotherapy or chemo, the wearable device helped patients live longer in a trial, though the results are somewhat controversial.

BTIG analysts wrote that installations of Intuitive’s new robotic surgery system are “well ahead of lofty” expectations.

Companies will be required to disclose more information about minority investors and past M&A activity. Provider groups said the new requirements would be burdensome for hospitals.

FDA Commissioner Robert Califf and two colleagues warned that the “scale of effort” needed to repeatedly evaluate AI models “could be beyond any current regulatory scheme.” ...