Radiaction Medical has secured an additional 510(k) clearance for its Radiation Shielding System from the US Food and Drug Administration (FDA).
This clearance enables the use of the system with the Siemens Artis family of fluoroscopy C-arm machines.
Introduced earlier in the year, the Shield System works as an accessory to new and legacy Artis C-arm models.
It is a completely automated and integrated, head-to-toe shielding device, which has been designed to block radiation scatter at its source.
This latest authorisation builds on the device’s previous clearance with Toshiba Infinix-I systems.
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It also allows the Shield System to be leveraged in several interventional cardiology and electrophysiology laboratories in the US.
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By GlobalDataThis expands the availability of the Radiation Shielding System to more physicians and staff.
Radiaction Medical CEO Jonathan Yifat said: “The reactions to our Shield System technology and capabilities have been extremely encouraging.
“Awareness has been growing about the negative implications of staff radiation exposure in interventional labs, but until now, there was no meaningful, comprehensive way to address the problem.
“We are now in a historic position and uniquely poised to drive a truly novel, integrated and automated solution to market, and directly into the hands of the dedicated healthcare providers at all levels delivering top-tier patient care.”
According to the company, its protection technology blocks radiation exposure for staff and avoids the limitations of currently available solutions.
These limitations include gaps in complete body coverage, resulting in reduced protection to staff, and creating obstructions that limit patient access.
Clinical studies have also demonstrated that Radiaction’s Shield System can reduce radiation scatter to the complete interventional lab by more than 90%.
