FDA clears ControlRad Trace for OEC C-arms

By AuntMinnie.com staff writers

September 15, 2020 -- ControlRad has received 510(k) clearance from the U.S. Food and Drug Administration for the marketing of its Trace fluoroscopy radiation dose reduction technology with GE OEC 9900 Mobile C-arms from GE Healthcare.

Trace can be integrated on existing mobile C-arms and utilizes a proprietary semitransparent filter, tablet along with enhanced image-processing techniques to lower radiation dose for any fluoroscopic imaging procedure. ControlRad received the original clearance for Trace in 2019.

ControlRad Trace Model 9 installed on the GE OEC 9900 Elite mobile C-arm
ControlRad Trace Model 9 installed on the GE OEC 9900 Elite mobile C-arm. Image courtesy of ControlRad.

The clearance will allow ControlRad to sell Trace as an add-on to GE OEC 9900 Mobile C-arms installed in the field.

In other news, ControlRad announced that it had completed a series C financing led by existing investor Questa Capital. The financing includes new investor Windham Ventures.


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