Medstone panel review.
This article was originally published in The Gray Sheet
FDA's Gastroenterology and Urology Devices Panel is slated to review a premarket approval application for Medstone's lithotripter in conjunction with Actigall (ursodiol USP) for non-invasive treatment of gallstones, the company says. FDA informed the firm on March 6 that it had filed the PMA, Medstone notes. Data included in the PMA shows adjunctive lithotripter use "speeds up clearance of the gallstones and results in higher success rates compared to drug therapy alone," the company claims...
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