The American College of Radiology (ACR) published updated guidelines (Feb. 19, 2017) regarding the NEMA XR-29 (MITA Smart Dose) Standard, finally 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," said 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," he added.
The SafeCT-29 system is an innovative 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.
The timing of this guideline announcement is critical as CMS penalties for non-compliance triples this year. Health institutes that did not receive OEM support for XR-29 compliance and did not purchase SafeCT-29 as a third-party FDA-cleared solution for CT and PET/CT scanners, may now have to start over and potentially be subject to the 15% CMS penalty, which went into effect on Jan. 1st 2017.
About Medic Vision
Medic Vision Imaging Solutions, Ltd. is a leading provider of cost-effective, vendor-independent image enhancement and dose management solutions for CT exams. Medic Vision's SafeCT® products are in routine clinical use at major hospitals and imaging centers nationwide, supporting scanners of all vendors. The company's SafeCT® product suite provides compliance with the latest regulatory requirements and initiatives related to CT radiation. For more information click HERE.
Media Contact:
Mr. Eli Rosenberg,
Medic Vision Marketing Manager
[email protected]
SOURCE Medic Vision
