Houston Medical Robotics, Inc. Receives FDA 510(k) Clearance for Euclid Teir 1 Mini Access System
HOUSTON, March 5, 2012 /PRNewswire/ -- Houston Medical Robotics, Inc. announces that it has received U.S. Food and Drug Administration 510(k) clearance to market the Euclid™ Tier 1 Mini Access System. The Euclid™ Tier 1 Mini Access System is a portable, hand-held device that integrates commercially available ultrasound imaging systems to facilitate placement of a needle and guidewire into a targeted anatomical location for a variety of therapeutics applications.
"Although numerous applications have been identified, our initial target for the Euclid™ Tier 1 Mini AccessSystem is reducing complications associated with central venous catheter (CVC) placement," stated Jeffery J. Sheldon, Houston Medical Robotics, Inc. Chairman & CEO. “With over 5 million CVCs placed each year- and published complication rates are as high as 26% - we are poised to make a significant impact on healthcare outcomes,” stated Mr. Sheldon.
Technology limitations, inadequate procedure training & exposure, and varying patient size & morphology have all been identified as co-contributors to the high CVC placement complication rates. Use of ultrasound imaging during procedures has been shown to reduce complications; however, the procedure is cumbersome and generally requires additional assistance. “The Euclid™ Tier 1 Mini Access System places all the necessary tools and consumables readily at hand for single-operator safe, effective, rapid, and cost-effectiveaccess,” stated Mr. Sheldon.
About Houston Medical Robotics, Inc.
Houston Medical Robotics, Inc. develops & commercializes revolutionary image guided hand-held medicalrobotics for use in various therapeutic applications. The devices provide safer, cheaper, and more effective procedure alternatives, thereby increasing caregiver efficiency, hospital & clinic revenue, and overall patient satisfaction. Houston Medical Robotics, Inc. raised $2.2 million from CitareTx Investment Partners I, LP, a Texas based medical device investment fund and business incubator, also founded and managed by Mr. Sheldon.