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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
The noninvasive system assesses the mechanical efficiency and electrical activity of the heart, acquiring signals through a hand-held, smartphone-connected device that sends data to a cloud for analysis. Read More