FDA has given 510(k) clearance to EOS Imaging’s 3D planning software for total knee arthroplasties. The green light continues the run of regulatory successes for EOS, which has now secured the OK to sell its full suite of EOSapps in the U.S.
KneeEOS, the latest app to receive FDA clearance, is the last step in a process that turns front and side-on images from a system sold by EOS into 3D models surgeons can use to plan knee operations. The 3D models generated by EOS’ team and rendered in kneeEOS allow surgeons to choose the size of implant needed for an operation and assess its positioning before starting a procedure. KneeEOS suggests the most appropriate implant and position based on the model.
Securing clearance to sell kneeEOS completes EOS’ push to bring its suite of EOSapps to market in the U.S. FDA signed off on hipEOS late in 2014, before going on to give its blessing to spineEOS earlier this year. HipEOS and spineEOS do for surgeons who perform total hip replacements and spine procedures what kneeOS does for their peers who work on knees.
Each of the apps fits in the broader suite of technologies, consumables and services EOS is pushing.
“The kneeEOS FDA clearance is an important milestone that allows us to offer our full set of software solutions to the U.S. market,” EOS CEO Marie Meynadier said in a statement. “It will support the growing adoption of EOS images, 3D models and patient-specific datasets at each step of the care continuum, helping healthcare providers bring the value of personalized treatments to their patients without the high dose and cost of CT imaging.”
EOS has built its business on EOS systems designed to capture frontal and side-on full body images without administering high doses of radiation. Staff at EOS turn these images into 3D models for use by surgeons with access to the EOSapps.
The approach is finding favor with healthcare professionals in the U.S., which has become an increasingly important market for EOS in the face of difficulties at its Asian operation. EOS sold 41 EOS systems over the first nine months of 2016, up from 30 over the same period of last year.