Heartflow, an artificial intelligence-based medical device software developer, filed for an initial public offering in the ...

The Electronic Health Record Association wants Health and Human Services leaders to address conflicting rules for analytics tools, and also seeks clarity on electronic case reporting requirements.

Meanwhile, Malaysia and China have started aligning and streamlining their medical device registrations through a first global regulatory reliance programme.

As the medical device industry continues to expand, intellectual property (IP) considerations — especially those concerning ...

The past six months at the US Department of Health and Human Services and the US Food and Drug Administration’s Center for Devices and ...

The FDA’s decision to clear the Apple Watch is a big deal because it shows they are open to new kinds of medical devices. It ...

Brazil is experiencing a regulatory revolution that is fundamentally transforming its medical device clinical trial landscape ...

OS Therapies (NYSE-A: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, to ...