Somanetics announces new FDA 510(K) clearance

Somanetics Corporation has announced a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the labeling for its INVOS(R) 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 2.5 kilograms (kg) at risk for reduced or absent blood flow. 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.

These changes make the INVOS System the only commercially-available cerebral/somatic oximeter backed by an improved patient outcomes claim, and the only cerebral/somatic system cleared for use on neonates less than 2.5 kg.

The INVOS (In Vivo Optical Spectroscopy) 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.

"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," explains Bruce Barrett, Somanetics' president and CEO.

Marc S. Kanchuger, MD, Associate Professor and Chief of Cardiothoracic Surgery and Transplant Anesthesia at NYU Medical Center adds, "I'm not surprised by the FDA's decision. We use the INVOS System routinely in all our cardiac surgeries in an effort to protect patients from ischemic brain complications. I suspect today's news will spark further adoption of the technology by the medical community."

Barrett continues, "Our expanded indication reinforces the device's applicability for on-label treatment of patients at any weight. For patients above 2.5 kilograms, including adults, children and most infants, our proprietary algorithm generates accurate, real-time measurements for immediate use by the care team. In patients below 2.5 kilograms, which is extremely common in our neonatal market, clinicians may use our device on-label as a trend monitor."

The labeling also removed "not demonstrated in disease states" from the indication for patients weighing greater than 2.5 kg, and includes additional 510(k) language on these three points: