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Heater cooler units used in cardiopulmonary bypass and extracorporeal membrane oxygenation can generate potentially infectious aerosols containing a range of harmful bacteria, some of which can be fatal, according to an ongoing UK investigation. Read More
The agency currently treats clinical data as confidential business information and only releases it if needed to protect public health or safety. Read More
A recently implemented decree by France’s Agency for the Safety of Health Products (ANSM) requires manufactures of Class III and implantable medical devices to provide new summaries of product characteristics when a device is put into service. Read More