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Priority Healthcare will pay Roche Diagnostics $43.3 million to settle a lawsuit alleging that it fraudulently submitted claims to insurers and pharmacy benefit managers for Roche’s Accu-Chek blood glucose test strips that put Roche on the hook for tens of millions of dollars. Read More
The European Commission (EC) has agreed on a common framework for the use and validation of rapid antigen tests and COVID-19 test results that EU member states will mutually recognize, as well as a standardized dataset to be included in test result certificates. Read More
The FDA’s top device officials admit that allowing a flood of COVID-19 diagnostic tests onto the market last year that did not go through the usual clearance or approval steps was a “flawed” approach. Read More
The company has developed a vital signs monitoring application that extracts vital signs from a video of a person’s face using the camera on devices including smartphones, tablets or personal computers. Read More
When the device’s hemostat powder makes contact with blood or fluid in the gastrointestinal tract, a gelled matrix forms to provide a barrier that helps to further control bleeding, the company said. Read More
The settlement, which requires the Alabama pharmacy operator to pay Roche $43.3 million dollars, also bars the corporation from purchasing, selling, distributing or dispensing Accu-Chek test strips. Read More
The company said the system’s closed-loop stimulation feature, which automatically adjusts to patients’ individual needs, is currently in clinical evaluation. Read More
The diagnostic is designed for professional use as a point-of-care test in clinical and non-clinical settings, including healthcare centers, travel hubs, educational institutions and businesses, PerkinElmer said. Read More