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

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

The U.S. Food and Drug Administration has pulled draft guidance from its website requiring companies to test medicines and ...

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

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

There are crescent-shaped devices, including the Hairmax LaserBand 82, that look similar to extra wide headbands. Because ...

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

Following the Trump administration's DEI ban, the FDA's move to scrub webpages has ensnared many pages focused on ensuring ...

Brenner, who worked in the FDA’s Center for Devices and Radiological Health, will take the helm of the agency until a new ...

Valencia-based Avita Medical Inc. has received FDA approval for a version of its second-generation Recell skin cell ...

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 ...