CurveBeam, LLC - Comment

CurveBeam, LLC, researches, designs and manufactures advanced 3D imaging equipment for the orthopedic and podiatric specialties. CurveBeam received FDA 510(k) approval for the pedCAT system, a cone beam computed tomography scanner for the foot and ankle region, in April, 2012. CurveBeam supports the FDA’s guidance to manufacturers seeking marketing clearance for a new X-ray imaging device with a pediatric indication to provide data supporting the safety and effectiveness of the device in pediatric populations. Specifically, CurveBeam supports FDA’s guidance to label devices with marketing clearance only for general indications to label the device with the statement, “CAUTION: Not for use on patients less than approximately <insert patient size (e.g., body part thickness or height and weight appropriate to your device)>." CurveBeam also supports the FDA’s guidance to include design features specific to pediatric patients for devices that are intended to be used for that population. Because pediatric populations are more radisensitive than adults, manufacturers should take every measure to ensure devices have proper labeling and sufficient dose control settings. CurveBeam concurs with all pragmatic efforts to reduce radiation dose to patients, both pediatric and adult, up to the extent that it does not jeopardize the quality of the diagnostic data produced. Hence the proposed guidance by the FDA should be issued in such a way that it does not alarm and discourage medical professionals from ordering scans that could be vital in examination and proper diagnosis and treatment of serious conditions that could pose far greater risk than the risk due to the radiation itself.