Examining The FDA's Recommendations For AI-Enabled Medical Devices
The FDA stated that its published medical device cybersecurity requirements from 2023 do include AI in a broad sense. However ...
US FDA's top lawyer Hilary Perkins resigns two days into role
The U.S. Food and Drug Administration's chief counsel, Hilary Perkins, has resigned, the federal agency said in a post on ...
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FDA issues cybersecurity risk alert over Contec patient monitor
The US Food and Drug Administration (FDA) has issued guidance over potential cybersecurity vulnerabilities with Contec’s CMS8000 patient monitor and the Epsimed MN-120 (a relabelled version of ...
JD Supra29d
CISA and FDA Sound Alarm on Backdoor Cybersecurity Threat with Patient Monitoring Devices
Last week, the U.S. Cybersecurity and Infrastructure Security Agency (“CISA”) and the U.S. Food and Drug Administration (“FDA”) released warnings about an embedded function they found in ...
Security Info Watch16d
Cybersecurity remains an afterthought. What will it take to make it a priority?
Cyberattacks on the software supply chain are a national security threat, necessitating stricter cybersecurity practices and ...
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Blue Goat Cyber Named Medical Device Cybersecurity Services Company Of The Year By Healthcare Business Review
Empowering MedTech Innovators to Achieve FDA Success and Protect Patient Safety Through Expert Cybersecurity. Founded by Christian Espinosa, a cybersecurity expert with over a decade of experience ...