Biopsy visualization unit gets nod

Ultrasound peripheral developer EchoCath received Food and DrugAdministration 510(k) approval in September for its ColorMarkdevice for improving needle visualization during ultrasound-guidedbiopsy.

The device consists of a vibrating clip attached to a biopsyneedle. The vibration creates a phase shift that shows up as amultihued stripe on color-flow Doppler scanners. EchoCath unveiledthe technology at the American Institute of Ultrasound in Medicinemeeting in March (SCAN 5/19/93).

ColorMark could aid the transition of biopsy procedures fromCT to ultrasound, as well as increase the accuracy of fine-needleaspiration biopsy, the manufacturer said. EchoCath is developinga ColorMark system for the Bard biopsy gun.

The firm is gearing up production of ColorMark devices andintends to begin shipping product in the first quarter of nextyear.

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