Security News
Agency Seeks Congressional Authority to Require Makers to Take Certain StepsThe FDA has issued plans for advancing the safety of medical devices, including a proposal to impose new cybersecurity...
Dr. Suzanne Schwartz of the FDA clears up some myths and misunderstandings about medical device security in an in-depth interview. She'll be a featured speaker at Information Security Media...
Agency Clarifies When Manufacturers Need FDA Approval for Security ChangesTrying once again to clarify that security patches to medical devices usually don't need regulatory approval, the Food and...
'Recommendations for Smart, Safe and Secure Interactions'The Food and Drug Administration has issued final premarket guidance for how medical device manufacturers should address secure data...
Almost half a million people in the United States are highly recommended to get their pacemakers updated, as they are vulnerable to hacking. The Food and Drug Administration (FDA) has recalled...
Abbott Laboratories releases software fixes for pacemakers that could allow an attacker to wirelessly access the devices and steal personal data, drain the battery and disrupt normal...
Cardiac Pacemakers Require New Firmware to Fix VulnerabilitiesThe FDA on Tuesday issued its first recall of a network-connected implantable device due to cybersecurity vulnerabilities. Nearly...
Initiative Includes Testing Pre-Certification of SoftwareThe Food and Drug Administration plans to launch a new initiative to help address risks - including safety and security - of digital health...
The FDA sent Abbott Laboratories a warning letter citing that it had inadequately addressed the security of the maligned Merlin@home Transmitter.