After years of trying to find a home for our continuous temperature monitoring device, it has found a home with CAR-T and numerous pharma companies from the USA and EU. The FDA has demanded the CAR-T trials to use a preventive measure to document cytokine release syndrome (creates dangerous fever) which is an expected outcome of CAR-T treatment and indicates the therapy is working. The more soft tumor mass the greater the immune response which is somewhat paradoxical. The risk of identifying and responding to a fever from CRS is critical and a high% of patients die (based on the pharma companies data) when CRS is not detected early enough. So, the fever itself is a good indication but it does need to be controlled; this makes our device a perfect fit.
In our agreements, we discuss adverse event reporting. Our 510K indicates our device is usable by all people of all ages.
In the event of a reportable event, who and how should it be reported to FDA?
In our agreements, we discuss adverse event reporting. Our 510K indicates our device is usable by all people of all ages.
In the event of a reportable event, who and how should it be reported to FDA?