Galileo Gets Federal Go-Ahead to Market Gynecological Endoscope
The US Food and Drug Administration has granted Galileo Corp. of Sturbridge, Mass., a 510(k) approval for the marketing of its rigid hysteroscopes for gynecological procedures. The approval comes on the heels of an earlier federal blessing to market rigid endoscopes for thoracoscopic, nasopharyngoscopic and general laparoscopic applications. The hysteroscopes give physicians direct visualization of the cervical canal and uterine cavity during diagnostic and surgical procedures. The company is developing a line of smaller-diameter, flexible hysteroscopes, which it estimates will hit the market by the third quarter of this year.
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