Clear Guide Medical’s new approach to ultrasound guidance for inserting needles received FDA approval last month, clearing the way for marketing and sale of the device in the United States.
The Clear Guide One was approved for “augmenting 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 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.”
The Clear Guide One features a compact, ergonomically designed ultrasound probe attachment to provide accurate and immediate real-time needle guidance. Physicians can visualize the needle path on-screen before entering the patient, allowing better planning of the intervention and more accuracy in placement.
The Clear Guide SuperPROBE combines a conventional ultrasound probe with the novel Clear Guide navigation head, which tracks needles and other tools and gives real-time information about the scene to the Clear Guide CORE unit for live needle-path display. The interventionalist can define targets directly on the CORE unit’s touch screen.
The company will take preorders for the system at conferences, including the RSNA annual meeting and MEDICA in Germany, both taking place in November. Preorders can also be placed by contacting the company directly.