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The EU’s Medical Device Coordination Group released new guidance on cybersecurity requirements for devicemakers under the new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). Read More
The EU’s Medical Device Coordination Group released new guidance on cybersecurity requirements for devicemakers under the new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). Read More
Catheters manufactured between Aug. 13-16 have marker bands that may experience buckling or could dislodge from their original position, the agency said. Read More
The Federal Court of Australia has found Johnson & Johnson responsible in a lawsuit by more than 1,350 women over injuries linked to failures of its pelvic mesh. Read More
Medtronic does not recommend prophylactic replacement of potentially affected pumps in patients because of the risks associated with replacement surgery. Read More
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