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 ...
Healio22m
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 ...
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 ...
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.
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 ...
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 ...