Boston-based company gets FDA clearance for noninvasive monitor aimed to help trauma-care clinicians treat patients in shock

reflectance careguide

Reflectance Medical, Inc. has received FDA 510(k) clearance for a noninvasive device that could help clinicians determine whether a patient is in shock or pre-shock or has tissue acidosis in real time at the point of injury or care. It’s the only noninvasive pHm monitoring device, and aims to save providers money by reducing ICU admissions and the length of ICU stays by decreasing the number of hospital-acquired infections.

Originally thought up as a response to a military solicitation to help medics treat injuries on the battlefield, the battery-powered Multi-Parameter Mobile CareGuide 3100 monitors muscle oxygen saturation and pH, which normally must be measured through blood tests. Because sticks or catheters are normally required to measure pH, that this device is noninvasive could limit the number of hospital-acquired infections, thus reducing the length of ICU stays.

“If you identify someone before they actually go into shock, we can prevent complications that would keep them from staying the hospital for a long time,” founder and CEO Babs Soller said.

With these measurements, the device can also offer information about whether a patient in shock’s muscles are acidic, or have acidosis, allowing clinicians to respond and treat with realtime feedback.

“Right now what happens is in a trauma situation the EMT will pick up somebody, they get to the emergency department, and they’ll be treated as rapidly as possible,” Soller said, “but really the first 10, 15, 20 minutes are really important. . . .They could start and optimize treatment earlier.”

The device works by throwing near-infrared light onto a patient’s skin, then measuring how much of that light is reflected and how much is absorbed. That measurement reads how much hemoglobin is oxygenated and applies an algorithm to chart pH levels and muscle-oxygen saturation ratios. The data then appears on a monitor, sold by the company’s partners–ZOLL Medical and Sotera Wireless.

This sensor is cleared to account and adjust for different patients’ varying skin colors and thicknesses of fat–also unique.

Reflectance sells the device to its partners, who then sell this product directly to hospitals, ambulance services and the military.

Though the device is currently aimed at trauma and critical care markets, Soller said the technology could also prove useful in chronic care, and Reflectance is working in that direction, too. The company has developed an Android app that, with the device, could work as a remote patient monitoring system in the future.

If so, it would be unique in that it would provide more than “crude measurements,” Soller said. The goal of all these products: to keep patients out of the ER and clinicians equipped with more “realtime decision support.”

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