According to the FDA’s public database, since the start of this year, the agency has issued only two de novo medical device ...

Switzerland is working toward reestablishing its relationship with the EU while exploring new avenues. Meanwhile, the U.K. is ...

The integration of AI and cloud technologies is transforming pharmaceutical manufacturing regulations, focusing on safety, efficiency, and global harmonization.

Press Release Powerful Medical, a leader in AI-driven cardiovascular diagnostics, announces that its PMcardio STEMI AI ECG model has been granted Breakthrough Device Designation by the US Food and ...

Transparent, well-designed clinical trials are a must. FastWave Medical's Scott Nelson has advice on how to get there.

The agency OK’d an artificial vessel to restore blood flow in patients, even though its own scientists flagged questionable ...

The U.S. Food and Drug Administration (FDA) has announced a series of critical updates this week, reflecting its ongoing commitment to advancing public health and medical safety.

Attorney Simon Purnell of Griffin Purnell said he thinks the courts' view of preemption is a "fundamental misunderstanding of ...

A quality management system (QMS) can often become bloated and unwieldy. This expert helps you understand key QMS basics and ...

Mehmet Oz, President Trump’s pick to lead the CMS, said Medicare beneficiaries should have quicker access to new medical ...

Industry leaders say government failed to protect Thomas Cooper from dying in a hyperbaric chamber fire at the Oxford Center ...

Katherine Legge said she’ll be better than her Phoenix debut but some drivers raise questions about NASCAR’s approval process, saying it put Legge and Helio Castroneves in difficult situations in ...