Somanetics wins FDA clearance to expand labeling for Invos oximeter

Somanetics, a developer of non-invasive patient monitoring systems, has received a new 510(k) clearance from the FDA to expand the labeling for its Invos cerebral/somatic oximeter.

The new labeling allows a claim of improved patient outcomes after surgery when the Invos system is used to manage therapies in patients above 2.5kg at risk for reduced or absent blood flow, the company said. Additionally, its indications for use now reflect the Invos system’s ability to generate accurate 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, the company noted.

According to Somanetics, the Invos cerebral/somatic oximeter non-invasively 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.

Bruce Barrett, president and chief executive officer of Somanetics, said: The clinical data we submitted and subsequent 510(k) clearance demonstrate that improved patient outcomes are possible with the use of our Invos system, and that our device can benefit cardiac surgery patients as well as high-risk general surgery patients, such as the elderly undergoing major abdominal surgery.