Medtech & Devices

New research shows up to 1,000 patients harmed by medical device breaches

As many as 1,000 patients suffered harm from medical devices hit by a cybersecurity attack, according to a new survey of executives of device manufacturers and provider organizations.The survey, conducted by researchers at the University of California San Diego, is scheduled for publication in an academic journal. The results were announced by Christian Dameff, M.D.,

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Medical Device Cyber Vulnerabilities: More Alerts

The stream of recent advisories is helping to draw more attention to the importance of addressing device security, many security experts say.Since April, DHS’s Industrial Control Systems Emergency Response Team has issued about a half dozen alerts advising healthcare entities of cyber vulnerabilities in equipment ranging from medical imaging systems to patient monitoring gear.The intensifying

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FDA Unveils Plan for ‘Software as a Medical Device’ Review

The proposed voluntary program is for review of “software-as-a-medical-device” products, or SaMD – software that is “intended to treat, diagnose, cure, mitigate or prevent disease or other conditions.” Today, such software faces the same regulatory review as medical device hardware.Examples of SaMD range from software that allows a smartphone to view images obtained from a

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Abbott releases firmware patch to fix cybersecurity flaws in 350,000 medical devices

The device manufacturer acquired St. Jude Medical last year and has since been working to fix severe vulnerabilities found in its pacemakers. Abbott released its second and final round of planned cybersecurity updates to its pacemakers, programmers and remote monitoring systems to fix severe cybersecurity flaws in the devices.The patch will update the battery performance

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