PARK CITY, Utah--(BUSINESS WIRE)-- CIRCA Scientific today announced that its CIRCA S-CATH™ and CIRCA Temperature Monitoring System™ have received 510(k) clearance in the U.S. by the Food and Drug Administration (FDA).
The CIRCA S-CATH and the CIRCA Temperature Monitoring System address the problems associated with slow, single sensor, and small surface area standard esophageal temperature probes and monitors.
Standard esophageal temperature probes are constructed with a single thermistor or thermocouple embedded inside a 3-5mm wide probe tip. These standard probes are used during a variety of procedures but are slow to respond to temperature changes and difficult to see under x-ray guidance. For example, some temperature probes and monitors only display new temperatures 1 or 2 times every 2 seconds, and only cover a small 3-5mm wide area of the esophagus’s 10-20mm potential width.
CIRCA’s single-use S-CATH includes 12 temperature sensors that continuously sense for new temperatures. In addition, the S-CATH deploys in a two-plane modified “S” configuration to cover up to an 18mm+ wide area of the esophagus and improve esophageal visualization under x-ray.
The re-usable CIRCA Temperature Monitoring System is a compact touch screen monitor that displays the individual temperature of each sensor 20-times-per-second. The monitor also simultaneously displays the warmest sensor on the probe. Temperatures are displayed in numerical and graphical formats and the clinician can set audible/visual warnings and alarms.
“The CIRCA S-CATH and CIRCA Temperature Monitoring System can improve temperature sensing speed, surface area coverage, and fluoroscopic x-ray visibility in the esophagus,” explained Lee Geist, CIRCA Scientific’s Chief Executive Officer. “The CIRCA team did an excellent job creating a best-in-class temperature probe and monitoring system to improve the quality and quantity of temperature data for the clinician.”
CIRCA Scientific plans to launch the CIRCA S-CATH and the CIRCA Temperature Monitoring System in the United States in 2011. CIRCA Scientific was funded in 2010 based on intellectual property from Shawn Fojtik to innovate safe, accurate, and fast technologies for improved patient care. U.S. and foreign patents pending. More information on CIRCA Scientific can be found at www.CIRCASCIENTIFIC.com.
Lawrence Kronick, 954-457-2450
KEYWORDS: United States North America Utah
INDUSTRY KEYWORDS: Health Biotechnology Cardiology Hospitals Medical Devices FDA Medical Supplies