Resyca Receives Medical Device Regulation Certificate From TÜV SÜD
MDR Certification Strengthens Resyca’s Leadership in Soft Mist Drug-Device Combination Products ENSCHEDE, NL / ACCESS ...
Healio13m
FDA recalls Mercury Medical T-piece resuscitator due to ventilation control component
The FDA has recalled Mercury Medical’s Neo-Tee T-Piece Resuscitator, a gas powered resuscitator intended primarily for ...
medtechdive6h
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.
dermatologyadvisor7h
FDA Alert: Pulmonology Drug Approvals, Recalls, and Device Updates
FDA 2025 pulmonology drug alerts, including drug approvals/warnings, vaccine approvals, and medical device recalls/updates.
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 ...
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 ...
Obesity-drug maker Metsera posts largest gain as IPOs defy market swoon
Oil company Natural Resources and medical-device maker Beta Bionics shrug off a down market to gain in their trading debuts.
The Hacker News9h
CISA and FDA Warn of Critical Backdoor in Contec CMS8000 Patient Monitors
Unpatched vulnerabilities in Contec CMS8000 patient monitors expose devices to remote access, file overwrites, and data leaks ...
JD Supra3h
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 ...
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 ...
SecurityWeek10h
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.