The US Food and Drug Administration (FDA) has requested that BeamMed, a subsidiary (45%) of DNA Biomedical Solutions Ltd. (TASE: DNA), that develops devices to diagnose bone density, respond to questions regarding its request to market its new product, MiniOmni.

DNA said that they are not substantive questions, but are significant since they are delaying approval by at least a few months. The product was submitted for approval on the 510k track, the shortest track in the medical device field.

BeamMed has already received marketing approval for its Omnisense device, which had first quarter sales totaling $644,000.

The MiniOmni is a small, portable and inexpensive device that runs on the same technology and has some of the same components. In the file it submitted to the FDA, BeamMed also asked for approval for four transducers (which are consumable parts). Three of them have already received approval along with the Omnisense device, and the fourth is a new transducer.

BeamMed reported that within the next two weeks it intends to submit its response to the questions regarding the MiniOmni and to supply the requested data. At the same time, BeamMed will respond to questions about the three transducers that have already been approved, and will supply the requested information. BeamMed will submit a separate response dealing with the fourth transducer, since most of the questions were surrounding this device.

DNA is traded on the TASE at a market cap of NIS 36 million.

Published by Globes [online], Israel business news - www.globes-online.com - on June 28, 2011

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