The FDA has recalled Mercury Medical’s Neo-Tee T-Piece Resuscitator, a gas powered resuscitator intended primarily for ...

Last week, the US Court of Appeals for the Fourth Circuit in United States v. Jackson upheld a doctor’s conviction under Section 301(k) of the ...

The Cybersecurity and Infrastructure Security Agency and Food and Drug Administration Jan. 30 released notices warning of ...

The FDA’s framework for AI regulation, while robust for premarket evaluation, would benefit from more specific mechanisms for continuous monitoring of AI performance in diverse real-world settings.

Pharma, biopharma, and medical device makers should watch out for these perennial problems, which include inadequate ...

The backdoor on Contec CMS8000 patient-monitoring devices could allow an IP address at an unnamed university to remotely ...

Vulnerabilities in certain Contec and Epsimed patient monitors can allow people to gain access and potentially manipulate the ...

Vertex Pharmaceuticals won approval from the U.S. Food and Drug Administration for a non-opioid pain drug, clearing the way for the rollout of a product that has simultaneously sparked high hopes and ...

What will the industry face or achieve in 2025? These trends will be critical in medical device cybersecurity.

The FDA says the cybersecurity vulnerabilities identified may put patients at risk when the device is connected to the internet.

The FDA alerts healthcare providers that certain patient monitors from Contec and Epsimed are gathering data and beaming it to a hardcoded IP address.

Susan Krause of Rosemount alleges New Jersey-based Integra LifeSciences pressured her to lie to regulators. Integra says ...