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Blood centers can use the device to convert a unit of conventional, leukoreduced RBCs into a transfusion-ready unit that offloads oxygen better than conventional blood and reduces progressive damage during storage, the company said. Read More
Once a product is on the authorized list, companies must notify the agency at least five business days before they import a designated device. Read More
MedTech Europe noted that any joint EU clinical assessment “must have a clear purpose and their results must also enable appropriate real-life funding or reimbursement decisions taken within member states.” Read More
Devicemakers will need to submit applications to the TGA to show that risk mitigation strategies are in place and that the IVDs comply with performance requirements. Read More
The system processes images using algorithms that identify and highlight abnormalities consistent with polyps, including small flat polyps that could otherwise go undetected. Read More
The European Commission’s Medical Device Coordination Group (MDCG) released a Q&A document to help answer questions relating to custom-made devices covered under the EU Medical Device Regulation (MDR). Read More
EU member states have agreed to start negotiations on a proposal that could lead to joint health technology assessments (HTAs) in the bloc, but MedTech Europe and the European Federation of Pharmaceutical Industries and Associations (EFPIA) are worried about some elements of the proposal. Read More