FDA clears 2 Brainlab software applications

By AuntMinnie.com staff writers

September 21, 2017 -- The U.S. Food and Drug Administration (FDA) has cleared two software applications from image-guided therapy firm Brainlab for patient-tailored planning of radiosurgery treatments for the spine and brain.

Elements Spine SRS accounts for variations in the curvature of the spine and ensures that high doses of radiation are delivered to the tumor and not the spinal cord itself, Brainlab said. Another application, Elements Cranial SRS, allows physicians to create a radiosurgery plan in less than 15 minutes, and it supports indications such as arteriovenous malformations, pituitary adenoma, vestibular schwannoma, glioma, meningioma, and large brain metastases.

Elements Spine SRS and Elements Cranial SRS gained CE Mark approval in May. The first patients were treated with Elements Spine SRS at Instituto Privado de Radioterapia Oncológica in Córdoba, Argentina, and with Spine SRS and Cranial SRS at the University Medical Center Hamburg-Eppendorf in Germany, according to the firm.

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