SafeStitch Medical Receives FDA Approval for SMARTTMDilator

It brings us great satisfaction when we are able to help our medical device customers achieve significant product development milestones. One such milestone was recently achieved by SafeStitch Medical when the FDA approved the SMARTTM Dilator medical device. In its AprilSafeStitch edition, Gastroenterology and Endoscopy News reports that the SMARTTM Dilator is the "first esophageal dilator that indicates the amount of pressure being applied at the esophageal stricture, hopefully reducing the incidence of esophageal perforation."
Smart Dilator 

SafeStitch Medical approached PADT to help design and develop early prototypes of the SMARTTM  Dilator product concept. We worked closely with the SafeStitch's clinical, engineering, and regulatory team to establish product and design requirements through early prototype testing.  The early development work was performed within PADT's FDA Compliant Quality System and the Design History File was subsequently transferred to SafeStitch for final development
and fabrication.

PADT Medical helps emerging medical device companies, like SafeStitch Medical, that are commercializing new products and need outside engineering expertise to help develop their innovative device concepts. We enable reduced time-to-market by utilizing our established quality system, computer simulation, and rapid prototype testing to quickly converge on design solutions. Contact us to learn more about how you can achieve early milestones with your innovative medical device concept.