News

Medical Device Cybersecurity And The Not-So-Hidden Threat Of Backdoors
As devices come onto the market that have to follow the new FDA guidance of SBOMs and patching, backdoors may become easier ...
FDA stops Olympus devices from entering the US
The agency said it issued the import alerts because it “continues to have concerns related to outstanding Quality System ...
Medical Device Network on MSN12d
FDA tags Medtronic’s voluntary ventilator recall as Class I after patient death
Relating to certain of Medtronic’s Newport ventilator range, users have been advised to remove the affected units from ...
Fierce Biotech11h
FDA moves to block Olympus endoscope imports over manufacturing issues
The FDA is shutting the door to imports of certain endoscope hardware manufactured by Olympus, saying that a production site in Japan has failed to meet quality requirements. | The FDA is shutting the ...
Florida AG subpoenas Chinese company over 'compromised' medical devices that can transmit private data
Florida's attorney general takes legal action against Chinese medical device maker Contec for allegedly selling compromised ...
Infectious Disease Advisor13d
FDA Plans to Use AI to Speed Up Drug and Food Safety Reviews
The US Food and Drug Administration says it plans to use artificial intelligence to help speed the approval of new drugs and medical devices.
Applied Clinical Trials Online7d
The Future of Cardiac Safety: How Wearable ECGs Enhance Patient Monitoring in Drug Trials
As wearable ECG technology advances, cardiac safety studies in clinical trials are evolving to capture richer, continuous ...
ET HealthWorld12d
Study evaluating efficacy of Sirolimus-Coated Balloon against Drug-eluting Stent completes patient enrollment
The trial has enrolled a total of 1,832 patients and designed to evaluate the safety and effectiveness of the MagicTouch ...