Clear Guide Medical announced that its first clinical product, the CLEAR GUIDE ONE, was cleared by the United States' Food and Drug Administration on September 19, 2014. This opens the door to marketing and sale of the device in the United States.
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.
CEO Dorothee Heisenberg stated, "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 pre-orders of the CLEAR GUIDE ONE at conferences such as the American Society of Anesthesiologists meeting, MEDICA in Germany, the Radiological Society of North America meeting, and, of course, at firstname.lastname@example.org. This is an important day for Clear Guide Medical."
The CLEAR GUIDE ONE revolutionizes 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 CLEAR GUIDE ONE 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 is a radical innovation in the field of image guidance because of its price and simplicity. Best of all, the CLEAR GUIDE ONE can be used with most existing ultrasound systems and the physician's 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.
ABOUT CLEAR GUIDE MEDICAL
Clear Guide Medical, a 2010 Johns Hopkins University spin-off, is a privately-held company based in Baltimore, MD developing innovative technologies to provide advanced image-guidance for needle-based interventions and diagnostics. The company won the 2013 Maryland Incubator Company of the Year Award and was selected as a TEDMED Hive participant in 2014. The company has received over $3 million in public and angel funding and is currently seeking private investment. More information can be found at www.clearguidemedical.com.