Patients who put their lives in the hands of healthcare institutions and personnel do so with an unmitigated amount of trust, ...

ALBAWABA - The Food and Drug Administration (FDA), which is responsible for protecting public health by ensuring the safety, efficacy, and security of d ...

The issue is that banning all PFAS from medical devices would threaten care for the Americans who receive 300,000 newly ...

AI is a transformational force in healthcare, but without cybersecurity as its foundation, it becomes a high-stakes gamble.

This article explores the global regulatory landscape, examining how leading authorities in the U.S., EU, U.K., Canada, China ...

The medical device industry can take steps right now on PFAS for safety, sustainability and to steer other industries in the ...

The U.S. Food and Drug Administration (FDA) recently announced it plans to phase out animal testing in the development of monoclonal ...

The spectrum of medical device products ranges widely in value, complexity and customization, from tongue depressors to CT ...

EMED Technologies Director of Clinical Affairs Alex Nikanorov shares the company’s approach to deciding which clinical ...

This approach attempts to strike a balance between innovation and oversight, but it's still an evolving process with ... The FDA regulates AI as a medical device under its Digital Health Software ...

DUBLIN--(BUSINESS WIRE)--The "Medical Devices: Developing Effective ... QMS problem remediation and FDA responses, new / changed product 510(k)s, process/ product/ equipment including QMS and ...