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

Tazbaz was director of the FDA’s Digital Health Center of Excellence for two years, leading key policies on artificial ...

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 ...

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

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.

Patient monitors, used in both healthcare facilities and home settings, display vital patient information including ...

CISA and FDA say Contec patient monitors used in the US contain a backdoor that could allow remote attackers to tamper with the device.

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

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 ...

UW Medicine is unveiling an FDA-approved spinal cord therapy in an effort to offer new hope for paralyzed patients.

2025 is a truly pivotal year, expected to end with the commercialization of our first AI-based Software as a Medical Device, ...