Clear Guide Medical Receives FDA 510(k) Clearance on Clear Guide One

October 9, 2014 — Clear Guide Medical announced the U.S. Food and Drug Administration (FDA) has cleared its Clear Guide One product. In addition, following a recent assessment of its quality management system by the British Standards Institute (bsi.), Clear Guide Medical has been recommended for certification to ISO 13485:2003.

"We are extremely pleased that the FDA's 510(k) process moved along so quickly, and that we are close to receiving our CE and Health Canada certifications. We are now prepared to take preorders of the Clear Guide One at conferences such as the American Society of Anesthesiologists meeting, MEDICA in Germany, the Radiological Society of North America (RSNA) meeting and at [email protected]," said CEO Dorothee Heisenberg.

The Clear Guide One aids medical image guidance with a compact, easy-to-use ultrasound probe attachment that provides accurate and immediate real-time needle guidance. Based on advances in computer vision research, the system allows the physician to visualize the needle path on-screen before entering the patient, allowing better planning of the intervention and more accuracy in placement.

The Clear Guide One can be used with most existing ultrasound systems and physicians’ customary needles and tools, with minimal user training. The system makes using guidance for inserting needles into patients the new standard of care, leading to better patient access and outcomes, and lower healthcare costs.

For more information: www.clearguidemedical.com