FDA greenlights Brainlab's radiosurgery planning software

An image from the Elements Spine SRS software. (Brainlab)

Brainlab snagged a pair of FDA nods for its software that helps surgeons plan radiosurgery of the spine and the brain. 

Radiosurgery involves using focused radiation to treat tumors in various parts of the body. It uses 3D imaging to guide radiation to the tumor without affecting the surrounding healthy tissue. Individualized surgical planning is crucial for spine and brain procedures due to the risk of damage to the nervous system. Brainlab's Elements software suite allows quick planning of radiosurgery procedures that spare healthy tissues and organs. 

“It became clear to us many years ago that radiosurgery plans must become more tailored to both the indication and the specific patient being treated,” said Brainlab CEO Stefan Vilsmeier in a statement. “With the positive reception of our Elements Multiple Brain Mets SRS software, which has already been used to create plans for hundreds of patients around the globe, Elements Cranial SRS and Spine SRS were a natural progression toward that goal.” 


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The Elements Cranial SRS produces radiosurgery plans in 15 minutes or less for a range of brain tumor types, including pituitary adenoma, vestibular schwannoma, glioma and large brain metastases. The Elements Spine SRS tackles challenges to radiosurgery of the spine, such as considering the curvature of the spine and making sure the radiation is confined to the tumor and does not affect the spinal cord. 

The cranial and spine versions of the software earned the CE mark in May this year. 

“We are highly impressed with the dosimetric results and the speed of plan optimization,” said Manuel Todorovic, head of clinical physics at University Hospital Hamburg-Eppendorf, the first hospital to treat a patient using the cranial software. “We ran a few plan comparisons between our other planning software and Elements Cranial SRS. The Brainlab software either produced plans of higher quality or plans of comparable quality in significantly shorter time.”

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