Medic Vision Imaging Solutions, the leading innovator of vendor-independent solutions for low-dose CT exams, announced today the FDA clearance of SafeCT-29 to help healthcare facilities achieve compliance as mandated by NEMA XR-29 "Smart Dose" standard.
"SafeCT-29 is the only FDA-cleared third-party solution on the market. Healthcare facilities will now have access to an innovative and affordable third-party solution that can help achieve compliance with the "Smart Dose" mandate," said Eyal Aharon, CEO, Medic Vision.
"We eliminated the need to replace thousands of fully-operational scanners and saved the healthcare industry billions of dollars in the process."
SafeCT-29 provides full compliance with the XR-29 Dose Check function for CT and PET/CT systems of all vendors and models. It is the only third-party solution that offers Dose Check functionality without interrupting or interfering with the scanner’s design and operation.
NEMA estimates that one-third of the current CT installation base may not be retrofitted by the OEMs to become XR-29 compliant. Now there is an alternative solution that can make the 4-slice, 8-slice, some 16-slice CT scanners, as well as the majority of PET/CT scanners, compliant.
"This FDA clearance is a significant achievement" said Aharon. "The year-long approval process was important to support healthcare initiatives designed to protect patient health and contain costs, Medic Vision has the solutions to help healthcare facilities achieve both goals."
SafeCT-29 is a patent-pending, innovative, add-on system that is easy to install and operate. It is fully automatic and maintains the scanner’s workflow. It connects to the CT console, analyzes dose data in real time, alerts the operator if the dose is too high, and prevents the patient scan until dose levels are changed or confirmed and justified.