FDA Clears World's First Noninvasive Continuous Temperature Monitoring System

Yael Waknine

September 14, 2010

September 14, 2010 — The US Food and Drug Administration (FDA) has granted 510(k) clearance for the world's first continuous and noninvasive temperature monitoring system (Abreu Brain Temperature Tunnel 700; Brain Tunnelgenix Corp).

The computer-based system features a far-infrared sensor that is placed on noninsulated skin between the eye and the eyelid (ie, at the inner corner of the eye), creating a direct and undisturbed link ("tunnel") to the thermal storage area in the brain.

Characterized by the company as the "first advance in modern thermometry in 300 years," the technology avoids interference from elements (eg, fat) that absorb the far-red infrared radiation that is transmitted as heat from the blood to the brain, and also bypasses barriers that insulate the brain, such as the scalp, cerebrospinal fluid, and meninges.

The system can be used during surgical procedures, replacing the traditional esophageal or Foley catheter–based monitoring devices that represent a significant source of potentially deadly infection. Additional applications include recovery room, intensive care unit, and general patient monitoring.

"[M]edical professionals and researchers will now have access to the first product in history that enables temperature to be continuously monitored on the only truly thermoconductive skin in the body," said Rick Foreman, chief executive officer of Brain Tunnelgenix, in a company news release. "This breakthrough will enable clinicians to escape their dependence on invasive thermometry and surface measurements across thermal barriers. With the exception of putting a sensor directly inside the brain, studies have shown that the [brain temperature tunnel] is the only sensor capable of detecting brain hypothermia and harmful cerebral hyperthermia."

Other benefits of the system include remote (wireless) monitoring of patient temperature from the nurse's station, eliminating middle-of-the night temperature checks, and early detection of infection, thereby potentially improving therapeutic efficacy.

According to the company news release, the thermal monitoring system is scheduled for official US launch at the American Society of Anesthesiologists' annual meeting, which will be held in San Diego, California, from October 16 to 20, 2010.