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In Brief: ADM Tronics

This article was originally published in The Gray Sheet

Executive Summary

ADM Tronics: Plans to make premarket submission this summer for its Sonotron pulsed radio frequency therapeutic device for the treatment of Carpel and Tarsal Tunnel Syndrome. The submission will include data from 50 patients studied at a single site. Preliminary study data show that out of 30 Carpel Tunnel patients treated with Sonotron, 21 show "improvement in either nerve conduction velocity" or "in the obtained amplitudes of response," ADM Tronics says. Results also show decreased pain, improvement in grip and pinch strength and an improvement in function of the affected hand. The device has been available in Italy and Japan since 1994. The Northvale, New Jersey-based firm also plans to pursue marketing clearance of the device for the treatment of osteoarthritis. ADM had submitted a 510(k) for the Sonotron to treat osteoarthritis ("The Gray Sheet" March 20, 1989, I&W-4), but withdrew the application to collect additional data...

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