FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support a regulatory decision about a drug or biological product’s ...

Rising demand for precision and personalized medicine has significantly augmented the need for artificial intelligence (AI)-enabled medical devices to deliver highly individualized diagnostics and ...

A recent article[1] authored by Haider J. Warraich, MD[2]; Troy Tazbaz[3]; and Robert M. Califf[4], MD in the Journal of the American Medical Association, reviews the history of artificial ...

The global healthcare landscape is undergoing a transformative shift driven by the integration of artificial intelligence technologies into medical devices. From diagnostic imaging to predictive ...

Federal Network Agency, Federal Commissioner for Data Protection and Freedom of Information and Hesse issue a joint “Roadmap” ...

Lawrence Tallon, CEO of the MHRA, discusses the agency's initiatives to advance the UK's regulatory protocols for medical devices.

Securing coverage, coding, and payment - the building blocks of healthcare reimbursement – can challenge any device manufacturer’s ability to launch medical devices in the U.S. Add a digital component ...

Casey Ross covers the use of artificial intelligence in medicine and its underlying questions of safety, fairness, and privacy. The Food and Drug Administration wants the developers of medical devices ...

Not surprisingly, AI is making inroads into medtech applications as companies seek to incorporate more intelligence in gathering and analyzing medical data and making informed real-time decisions as ...

SOPHIA ANTIPOLIS, France--(BUSINESS WIRE)--Regulatory News: Median Technologies (FR0011049824, ALMDT, PEA/SME eligible, “Median” or “The Company”), a leading developer of eyonis™, a suite of ...