Seattle-based startup Immunexpress is set to complete an FDA de novo filing for its SeptiCyteLab sepsis test that it says tells the physician the probability the patient has sepsis within a few hours. That would be a big step up from current sepsis diagnostics that can take over a day to complete and often provide no useful information, the firm says.
The company hopes FDA will clear SeptiCyte Lab by the end of 2015 with a market launch set for the...
Welcome to Medtech Insight
Create an account to read this article
Already a subscriber?