Johnson & Johnson, along with several media outlets, announced the FDA’s decision yesterday.
The ASA had voiced its concerns over the SEDASYS device at an FDA advisory panel meeting, after which the device was recommended for approval. Among the ASA’s concerns, listed in a letter (pdf) to Neel Patel of the FDA, are a lack of safety data related to the device, the limitations of the device to measure oxygen saturation and end tidal CO2 measurements and the inability of the device to prevent and manage loss of consciousness.
Read the ASA’s report on the FDA’s rejection of the SEDASYS anesthesia device.
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