The Clear Guide ONE was cleared by the United States Food and Drug Administration on September 19, 2014 for marketing and sale in the United States. The indications for use are:
"Clear Guide ONE is indicated for enhancing the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or ablation needle, and for predicting its future path on a touch-screen computer display which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system. The device is intended to be used in procedures where ultrasound is currently used for visualizing such procedures."
We are very pleased that the FDA's 510(k) process moved along so quickly. We are now prepared to take pre-orders of the Clear Guide ONE at MEDICA and, of course, at email@example.com.