FDA 510(k) Clearance for Euclid Tier 1 Mini Access

Houston Medical Robotics Inc.’s Euclid Tier 1 Mini Access System received U.S. Food and Drug Administration 510(k) clearance to market the 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 Access System is reducing complications associated with central venous catheter (CVC) placement," states Jeffery J. Sheldon, Houston Medical Robotics Inc. chairman and CEO. "With more than 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.” 

Identified as co-contributors to the high CVC placement complication rates are technology limitations, inadequate procedure training and exposure, and varying patient size and morphology. Use of ultrasound imaging during procedures shows 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-effective access," Sheldon concludes.