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news.SafeStitch Medical, a medical device company, has announced that the FDA has approved the company's 510(k) application to begin US marketing of its Smart Dilator.
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According to the company, Smart Dilator is the first esophageal dilator to indicate the pressure level being applied at the esophageal stricture.
Jeffrey Spragens, president and CEO of SafeStitch, said: “This FDA approval marks the completion of the development phase of our three introductory products: the Smart Dilator, Standard BiteBlock and Airway BiteBlock – and we will now begin our commercialization efforts for these products.
“Our product development efforts are now focused on SafeStitch’s hernia skin stapler and its minimally invasive gastroplasty devices for obesity and gastroesophageal reflux procedures.”