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.

Former CDRH leader Jeff Shuren told an audience at The Medtech Conference that Michelle Tarver “will make an excellent center director, and quite frankly, the best is yet to come.” ...

identifeye HEALTH, a medical diagnostics company at the forefront of AI and automation, is proud to announce the launch of the identifeye System, a retinal imaging camera designed to bring retinal ...

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

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.

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Robert Ford’s comments come as new CGMs and insulin pumps continue to roll out in the diabetes tech space, including over-the-counter glucose sensors.

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.” ...

Canada’s device agency plans to issue guidance on machine learning, and the FDA plans to release a draft guidance next year on lifecycle management and premarket submissions for AI devices.