FDA approves KarmelSonix's Wheezometer

The company plans to begin marketing the device in the US soon to medical professionals, and later plans sales for home use as well.

KarmelSonix Ltd. (ASX: KSX) has obtained US Food and Drug Administration (FDA) marketing clearance for the company's WheezoMeter, a diagnostic tool that measures a patient's wheezing before and after tests with a bronchodilator, thereby demonstrating the effectiveness of asthma treatments.

The company obtained EU CE Mark certification of the device in July, as well as from Australia's Therapeutic Goods Administration (TGA).

KarmelSonix has already begun sales of the WheezoMeter in several markets, and it is planning to raise capital. It plans to begin marketing in the US soon via local distributors to medical professionals, and later plans sales for home use as well.

The company manufactures the WheezoMeter, its Auxiliary Infant Sensor, and sub-assemblies and electronic sensors at its Haifa factory. The company said in its financial report, published last week, that sales of the device have reached $225,000.

KarmelSonix first product, the Pulmotrack, which is also a diagnostic tool for asthma, is already sold in Europe and the US.

KarmelSonix's share was unchanged at AU$0.05 on the Sydney Stock Exchange today.

Published by Globes [online], Israel business news - www.globes-online.com - on October 5, 2009

© Copyright of Globes Publisher Itonut (1983) Ltd. 2009

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