Clinical trials evaluating the device have been performed at the sites listed below. The clinical data generated in these trials has been reviewed by the Food and Drug Administration (FDA). In September of 2007, after a thorough evaluation of the device, the FDA cleared the AccuCirc for unrestricted use in the United States. Click here to download a PDF version of the AccuCirc 510(k).

• Hasbro Children’s Hospital/Brown University – Providence, RI
• Women and Infant’s Hospital/Brown University – Providence, RI
• West African Multi-Center Trial – Lagos, Ife, and Ibaden, Nigeria (ongoing)