SafeCT-29 is first third-party XR-29 solution to get FDA nod

by Gus Iversen, Editor in Chief | May 24, 2016
CT Risk Management X-Ray
With XR-29 raising the bar on what a CT scanner should be capable of, many hospitals have found themselves forced to choose between a costly capital investment and penalized reimbursement — but there may be a third option on the table.

After over a year of working with the FDA and redesigning their product, Israel-based Medic Vision has received clearance for a patent-pending XR-29 solution called SafeCT-29.

"We eliminated the need to replace thousands of fully-operational scanners and saved the health care industry billions of the dollars in the process," Eyal Aharon, CEO of Medic Vision, told HCB News, referring to NEMA's estimate that non-compliance could affect one-third of the CT scanners being used in the U.S.
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It's not the only third-party XR-29 solution, but it is the only one regulated by the FDA.

And with nothing comparable ever having been on the market, getting clearance wasn't easy. "In the beginning one of the major challenges for us as well as the FDA was finding some kind of similarity we can compare against," said Aharon.

Under XR-29, a facility will be docked 5 percent of its reimbursement on certain CT exams if their scanner does not meet four specific requirements. In 2017, that cut jumps to 15 percent.

The XR-29 requirements are:

  • Automatic exposure control (AEC) to access radiation dose in real time

  • Built-in adult and pediatric protocols for the operator to choose from

  • Dose Check for automatic notification of when scan settings are likely to exceed dose thresholds

  • DICOM SR to incorporate dose history into the patient record

According to Aharon, published reports have pointed to Dose Check as the XR-29 standard that costs most scanners compliance — and it is precisely what SafeCT-29 provides.

Scanner OEMs like Philips, Siemens, and GE have established upgrade pathways for many of their CT scanners to ensure compliance — but older models are being left behind, as well as the majority of PET/CT systems.

"We have heard from some of the vendors that they will not develop solutions for existing PET/CT systems," said Aharon, adding that those systems would be his company's primary marketing target.

Unlike the proprietary software packages that the manufacturers install on the scanners themselves, SafeCT-29 is an add-on system that is fully automatic and does not interfere with the scanner. It analyzes dose data in real time and alerts the operator if the dose is too high, while preventing the patient from being scanned until dose levels are changed or confirmed and justified.

So far, the FDA has not stated explicitly that regulatory clearance is a requirement for third-party XR-29 solutions, and there are a few companies competing in the market. One company offering its own third-party XR-29 solution is Zetta Medical Technologies with Z-Dose29.

It is Aharon's expectation that since the FDA went through the regulatory process with Medic Vision, it will become an established requirement going forward.

"The FDA has made it clear in numerous publications that any system that connects to a medical device such as a CT scanner and affects, interferes with, or interrupts its clinical operation, shall be considered a Class II Medical Device and therefore requires FDA clearance," Aharon wrote on the Medic Vision website.

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