The American College of Radiology (ACR) has published updated guidelines regarding the NEMA XR-29 (MITA Smart Dose) standard, setting a clear and specific set of guidelines for an acceptable Certificate of NEMA XR-29 Compliance.
The publication specifically declares, “certificates of NEMA XR-29 Compliance from 3rd party vendors are acceptable if: (1) the 3rd party vendor has obtained the required FDA 510(K) pre-market clearance for their upgrade product; and (2) the 3rd party vendor upgrade product has been approved by CMS.”
Furthermore, the document states, “Currently, the only FDA & CMS approved 3rd party vendor NEMA XR-29 upgrade product is the Medic Vision SafeCT-29.”
“The Medical Imaging community has been waiting for clear guidance since the XR-29 standard became effective in 2016,” says Eyal Aharon, CEO of Medic Vision. “We’ve advocated for clarity surrounding the XR-29 compliance guidelines that were too vague and raised concerns among CT operators and vendors. These updated guidelines not only provide clarity but ensure adherence to the highest standard for patient safety.”
The SafeCT-29 system is an add-on system that helps achieve compliance with the XR-29 standard for CT and PET/CT systems equipped with AEC and Reference protocols, by providing the XR-29 Dose Check and RDSR functions. It is the first and only FDA 510k-cleared third-party solution on the market.
According to Medic Vision, the timing of this guideline announcement is critical as CMS penalties for non-compliance triples this year.
For more information, visit Medic Vision.