Reflectance Medical of Westborough, MA received FDA 510(k) clearance to market the company’s CareGuide Oximeter, a hemoglobin oxygen saturation monitor of skeletal muscle tissue (SmO2).
According to the company, this is the first device approved by the FDA to continuously monitor SmO2, as well as the first to assess tissue perfusion in patients with pigmented skin.
The device uses near-infrared light to penetrate muscle tissue and measure the muscle oxygen saturation non-invasively, an indicator of whether a muscle is receiving sufficient oxygen for its labors.
More about the system from the product page:
Software upgrades will allow the sensor to simultaneously determine pH (acidosis) and hematocrit within muscle tissue. The combination of these three parameters will provide a very early indication of impaired tissue perfusion, the imbalance between available oxygen and tissue demand, as well as immediate, continuous feedback on the efficacy of therapy aimed at improving tissue perfusion. The system is based on a unique implementation of near infrared spectroscopy. The system consists of the following:
CareGuide™ Sensor: The sensor contains unique and innovative optical elements to collect muscle spectra from the patient. The spectra are processed by proprietary algorithms to calculate muscle oxygen, pH and hematocrit. Values are updated regularly and displayed on a monitor screen.
CareGuide™ Disposable: The single-use disposable provides a clean patient contact surface. The disposable is packaged with a proprietary material to ensure that the reusable sensor optics remain within spec. The disposable may be used for up to 72 hours.
CareGuide™ Display: Reflectance Medical’s CareGuide™ sensor is available to be interfaced to partner display units.
Product page: CareGuide Oximeter…