The US FDA has published updated information on heater-cooler devices used to warm or cool patients during surgery, which says the agency is working with industry to bring to market innovative devices that lower the risk of bacterial infection.
In 2017, the Food and Drug Administration updated its 2015 guidance, “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling,” to include water-based heater-cooler devices used in surgery to keep patients warm or cool.
Since then, the agency says it has been working with industry to bring innovative heater-coolers to market to lessen the...
From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.
Flow Neuroscience's neuromodulation headset for the treatment of depression is approved and marketed in the EU. However, two years on, the company is still waiting for US FDA approval despite being assigned breakthrough device designation.
Overlapping clinical testing requirements and decision-making around significant changes to MDAI are among the tricky subjects that the new document explains.
The UK's regulatory agency is the first to join a new international network for oversight of AI in healthcare run by a non-profit organization, HealthAI, the global agency for responsible AI in health.
Healthcare product industries await publication of the NHS 10-Year Plan, due out the coming days, which will focus on health generally not just the NHS, UK health secretary Wes Streeting said during a final prelaunch event on 24 June.
From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.
Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.
