Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were ...

The U.S. Food and Drug Administration has approved Onapgo (apomorphine hydrochloride) injection as the first and only ...

Medtech supplier Cortland Biomedical said the new designation positions it as a full-service contract manufacturer.

The Food and Drug Administration wants the developers of medical devices that rely on artificial intelligence to disclose much more detail about how their devices were developed and tested ...

The FDA warned the nation about the growing vulnerability of the medical device supply chain and its effects on public health, particularly among pediatric patients, in a Jan. 16 news release.

The future of medical devices has much potential, but they also have risks related to cybersecurity. In 2024, we saw the first full year of the Food and Drug Administration’s (FDA) new guidance ...

Panelists at an FDA Medical Devices Advisory Committee meeting in ... First, the FDA proposes that it may create a publicly available webpage listing all FDA-cleared pulse oximeters.

The U.S. Food and Drug Administration has approved Supernus Pharmaceuticals' drug-device combination to treat ...

The Food and Drug Administration is aiming to help developers of artificial intelligence-enabled medical devices understand the agency's mindset around the technology. The agency announced Monday ...