Functionality in the device firmware sends patient data to a hardcoded IP address that also downloads and executes binary files without the owner’s knowledge.

Cynthia Solano, 40, was sentenced this week to 87 months in prison, followed by 36 months of supervised release, by U.S.

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

Obesity-drug maker Metsera Inc.'s stock jumped 47% on Friday as the biggest gainer among three initial public offerings bucking a swoon in the equity market to rise in their stock-market debuts Friday ...

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

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

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.

ResMed stock is down today, even though the maker of CPAPs and other respiratory treatment devices had Street-beating Q2 ...

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