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 ...
medtechdive5h
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 ...
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.
GlobalData on MSN8h
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 internet.
US FDA Identifies Cybersecurity Risks in Certain Patient Monitors
(Reuters) - The U.S. Food and Drug Administration (FDA) said on Thursday it had identified three cybersecurity risks ...
Los Angeles Business Journal4d
Avita Gets FDA Nod For Device
Valencia-based Avita Medical Inc. has received FDA approval for a version of its second-generation Recell skin cell ...
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 ...
medtechdive4d
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 ...
aha.org3h
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 ...
US FDA drops web pages on improving clinical trial diversity
The U.S. Food and Drug Administration has pulled draft guidance from its website requiring companies to test medicines and ...
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 ...