Israel-based medical technology company Medic Vision Imaging Solutions has secured US Food and Drug Administration (FDA) approval for its SafeCT-29 system to assist healthcare facilities in complying with National Electrical Manufacturers Association (NEMA) XR-29 Smart Dose mandates.
According to NEMA estimates, one-third of current CT scan installation bases are not qualified to be retrofitted by the original equipment manufacturer (OEM) to comply with XR-29 mandates.
The comprehensive vendor-neutral solution, SafeCT-29 evolves as the only third-party solution enabling CT and PET / CT systems of all vendors and models to gain full compliance with the XR-29 Dose Check function without disrupting or interfering with the scanner's design and operation.
Medic Vision CEO Eyal Aharon said: "This FDA clearance is a significant achievement.
"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."
The SafeCT-29 is a patient-pending device used as an add-on system which is easy to install and operate.
The system integrates with the CT console to perform a real-time dose data analysis which issues alerts and notifies the operators, prior to the scan to report instances of estimated dose levels exceeding the pre-defined dose limits.
An initial alert halts the scanning automatically until dose levels are changed or confirmed by the operator.
All events and actions are recorded, logged and available for review and audit resulting to a safe scanning.