The company has made a 510k application which means that it should receive a final answer within 90 days.
D Medical Industries Ltd. (TASE:DMDC) announced today that its subsidiary NiliMEDIX has field a 510k fast-track application for US Food and Drug Administration (FDA) approval to market its disposable insulin pumps in the US. This means that the company should receive a final answer to its application within 90 days.
If approved by the FDA, NiliMedix will be able to immediately commence marketing its products, although this is still no guarantee that they will be successful. NiliMedix's insulin pumps are smaller and lighter and they break down less as they have no moving parts such as motor, or reduction gear.
D Medical rose 4% in morning trading following the announcement and it now has a market cap of NIS 64 million.
Published by Globes [online], Israel business news - www.globes.co.il - on March 25, 2007
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