JD Supra55m
Fourth Circuit Ruling Guts the Practice of Medicine Defense in FDA Cases
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 ...
2025 Medical Device Cybersecurity Trends: What Will Shape The Industry?
What will the industry face or achieve in 2025? These trends will be critical in medical device cybersecurity.
medtechdive3h
FDA warns about patient monitor cybersecurity vulnerabilities
Vulnerabilities in certain Contec and Epsimed patient monitors can allow people to gain access and potentially manipulate the ...
FDA issues cybersecurity risk alert over Contec patient monitor
The FDA says the cybersecurity vulnerabilities identified may put patients at risk when the device is connected to the ...
JD Supra3d
FDA Dumps Trio of Device-Related Guidances Prior to Administration Change
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 ...
SecurityWeek8h
CISA, FDA Warn of Dangerous Backdoor in Contec Patient Monitors
CISA and FDA say Contec patient monitors used in the US contain a backdoor that could allow remote attackers to tamper with the device.
STAT7d
FDA purges material on clinical trial diversity from its site, showing stakes of Trump DEI ban
Following the Trump administration's DEI ban, the FDA's move to scrub webpages has ensnared many pages focused on ensuring ...
Medical Design and Outsourcing7d
FDA’s Tarver pushes for mandatory medical device shortage reporting
The FDA is urging Congress to implement mandatory medical device shortage reporting to address growing vulnerabilities in the ...
The National Law Review10d
FDA Issues New Recommendations on Use of AI for Medical Devices, Drugs, and Biologics
In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued ...
medtechdive3d
FDA webpages on clinical trial diversity removed after Trump orders
The website changes raise concerns about “the interference of politics with the study and the practice” of science and ...
US FDA Drops Web Pages on Improving Clinical Trial Diversity
CHICAGO (Reuters) - The U.S. Food and Drug Administration has pulled draft guidance from its website requiring companies to ...
aha.org1h
CISA, FDA warn of vulnerabilities in Contec patient monitors
The Cybersecurity and Infrastructure Security Agency and Food and Drug Administration Jan. 30 released notices warning of ...