Tensys Medical Inc. aims to be the first to effectively penetrate the $1 billion worldwide continuous noninvasive blood pressure management market. Its T-Line incorporates a pressure sensor placed over the radial artery to provide real-time beat-to-beat measurement of a patient's blood pressure during surgery.
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HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.
The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.
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