Software-driven medical technology developer BrainLAB has secured 510(k) clearance from US Food and Drug Administration (FDA) for two software modules for radiation oncologists and neurosurgeons.
The company’s Adaptive Hybrid Surgery and Automatic Brain Metastases Planning software, part of the Brainlab Elements portfolio, builds on the company’s aim to enhance access and consistency of patient care.
Brainlab president Stefan Vilsmeier said: "FDA clearance of these software modules marks a critical milestone in the Brainlab vision of indication-specific tools.
"We expect their capabilities, efficiency and usability to help change the way certain life-threatening diseases are treated."
Adaptive Hybrid Surgery was designed to help physicians balance surgical risk with radiosurgical toxicity for multi-disciplinary treatment of skull-base tumours.
In addition, a complete set of automated tools will allow adjuvant radiosurgery analysis at any time, while planning and performing a surgical resection.
The Elements Intraoperative Structure Update will gather residual tumour volumes, based on points acquired inside the resection cavity, whereas an intuitive traffic light display offers comprehensive information regarding tumour coverage and critical dose constraints for calculated treatment plans.
Designed to consistently and rapidly generate radiosurgery plans for efficient treatment of multiple metastases, Automatic Brain Metastasis Planning software enables clinicians to plan and treat multiple brain metastases with time and dose efficiencies, while helping to minimise exposure to healthy surrounding tissue.