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The FDA has rejected a call for a total ban on transvaginal mesh products, saying complete market withdrawal is not an appropriate way to deal with serious safety concerns linked to the devices. Read More
Canadian devicemakers are praising their government’s plan to implement an internationally harmonized system of unique device identification, but say it must become “truly global” to avoid additional barriers to trade. Read More
Med-Mizer, a maker of electric, adjustable and bariatric hospital beds, received an FDA warning letter for failing to submit a timely MDR following a patient death. Read More
CareFusion received an FDA warning letter for failing to analyze debris and particulate matter on its shunts and inside peritoneal catheters and tubing. Read More
R&D Engineering, a maker of kidney transport trays, received an FDA warning letter for failing to secure identification labels on devices, among other quality issues. Read More