Tarver took the position in late July after the announcement that CDRH’s director of the past 15 years, Jeff Shuren, M.D., ...

Industry leaders explored the risks and benefits of adopting a China Plus One strategy at Advamed’s The MedTech Conference in ...

At The Medtech Conference, leaders explored the potential impact of the LDT rule, and what companies should expect in 2025 and beyond.

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.” ...

Regulators and medical device companies discussed recent attacks and how to prevent them at Advamed’s The Medtech Conference ...

As medtech companies, experts and regulators gather in Toronto, FDA leadership changes and the upcoming U.S. presidential ...

Medtech Innovator announced that it awarded the grand prize for its early-stage accelerator to AI-driven tech developer Samay ...

TORONTO—While the FDA has already doled out green lights to about 950 medical devices backed by artificial intelligence or ...

*Based on data released by the Federal Election Commission on October 13, 2024 except for independent expenditure and communication cost, contributions to federal candidates, and contributions from ...

Canada’s device agency plans to issue guidance on machine learning, and the FDA plans to release a draft guidance next year on lifecycle management and premarket submissions for AI devices.

The pediatric cardiology innovations include monitoring systems, handheld devices for imaging and diagnostics, and a ...