Clear Guide Medical’s Needle Guidance System Gets FDA Nod

September 26, 2014

Technology startup Clear Guide Medical said the FDA recently cleared its first product, the Clear Guide One, a navigation system that provides needle guidance and tracking for any ultrasound.

The Clear Guide One uses a compact, ultrasound probe attachment to provide accurate and real-time needle guidance. It allows the physician to visualize the needle path on-screen before entering the patient, allowing for better planning and accuracy of needle placement, the Baltimore, Md. devicemaker said Friday.

The Clear Guide One can be used with most existing ultrasound systems, needles and tools, and requires minimal training, the company said. Clear Guide Medical hopes that the device will make guidance for needle insertion the new standard of care and lower healthcare costs.

In addition to the FDA clearance on Sept. 19, the company also is close to receiving a CE mark and Health Canada certification, Clear Guide Medical CEO Dorothee Heisenberg, said. — Kellen Owings

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