Brain Tunnelgenix Technologies Corp. (BTT Corp.) announced today that the U.S. Food and Drug Administration (FDA) has granted the company clearance to market its Abreu BTT™ 700 System for continuous temperature monitoring. The Abreu BTT 700 System sensor is approved for placement on the skin and to be used during surgical procedures, recovery room, intensive care and general patient monitoring.
The Abreu BTT 700 System is the world’s first continuous and noninvasive device that measures temperature on the skin surface of the body with the highest thermoconductivity, the fat-free skin which overlies the Brain Temperature Tunnel™ (BTT™). Located between the eye and eyebrow, the BTT’s skin site lacks insulation tissue and the internal portion is in direct communication with the brain, thereby enabling temperature to be accurately and continuously monitored for the first time in history with the unimpeded transfer of internal thermal energy through the skin.
The Abreu BTT 700 System conquers the last frontier for monitoring vital signs — the continuous noninvasive monitoring of body temperature. Unlike blood pressure, heart rate, respiration and oxygen saturation, up to now temperature was the only vital sign that could not be noninvasively monitored in a continuous fashion; temperature needed to be measured and recorded manually by nurses or invasively by doctors using catheters during surgery. The Abreu BTT 700 System now allows for the first time in history full automation of patient monitoring with both wired and wireless signal transmission.
The Abreu BTT 700 System, which is protected by patents in the U.S. and abroad, will be available next month and will make its world debut at the Annual Meeting of the American Society of Anesthesiologists (ASA) in San Diego, CA.
“FDA approval of our Abreu BTT 700 System marks a successful milestone for BTT Corp., and we are excited that medical 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 BTT Corp. “BTT Corp. uniquely harnessed the best of biology to create the best of technology for safely and effectively monitoring temperature during surgical procedures and for recovery room, intensive care and general patient monitoring.
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 BTT is the only sensor capable of detecting brain hypothermia and harmful cerebral hyperthermia.”