Somanetics has received a 510(k) clearance from the FDA to expand the labeling for its In Vivo Optical Spectroscopy (INVOS) Cerebral/Somatic Oximeter to include a claim of "improved patient outcomes after surgery" when used to manage therapies in patients above 2.5 kilograms in patients at risk for reduced or absent blood flow.

Also, its indications for use now reflect the INVOS system's ability to generate real-time measurements of blood oxygen saturation in this same patient population, in addition to its previous clearance as a trend monitor in any individual, according to the Troy, Mich.-based company.

The INVOS Cerebral/Somatic Oximeter noninvasively monitors site-specific blood oxygen levels to help surgical and critical care teams protect their patients against brain and vital organ area damage, or even death, Somanetics said.