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The system will eventually be used to support surveillance of all medical devices and will enable patients to be contacted when safety concerns are identified. Read More
The companies will produce and sell P+F’s heart valve devices in China, Japan, Taiwan, South Korea, Singapore, Malaysia, Australia, New Zealand and Hong Kong. Read More
The device uses either anchoring nails or screws that can be delivered via multiple techniques, helping surgeons to address the anatomical challenges encountered in anterior cervical surgery. Read More
The assay could be used for “accurate evaluation of antibody status before and after infection, in antibody therapies or in vaccination programs,” said EUROIMMUN CEO Wolfgang Schlumberger. Read More
The FDA has received roughly 4,500 pre-Emergency Use Authorization (EUA) and EUA submissions, and the total volume of submissions received has doubled compared to a year ago. Read More
In a separate 13-3 vote with two abstentions, the expert panel concluded that the risks of the Neovasc Reducer System outweigh the benefits for specific patients. Read More