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Biotech / Medical : URMD -- Huge market potential

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To: Milk who wrote (291)6/24/1998 11:49:00 AM
From: Milk  Read Replies (2) of 369
 
Wednesday June 24, 9:18 am Eastern Time

UroMed seeks radioactive seed clearance

NEEDHAM, Mass., June 24 (Reuters) - UroMed Corp. said Wednesday that it has submitted a premarket notification 510(k) application to the U.S. Food and Drug Administration for market clearance for its radioactive seeds to be used to treat prostate cancer.
UroMed said its goal is to market the seeds in the first quarter of next year.

The company noted that review times at the FDA are currently estimated to average 90 days for premarket notifications.

The 510(k) application is used when there exist similar, previously-approved technologies in the marketplace.

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