German medical technology company Brainlab has obtained 510(k) approval from the US Food and Drug Administration for its two software modules for radiation oncologists and neurosurgeons.
After successful clinical use in several international markets, Hybrid Surgery and Automatic Brain Metastases Planning software are now available in the US, said Brainlab.
Adaptive Hybrid Surgery allows physicians to balance surgical risk with radiosurgical toxicity for multi-disciplinary treatment of skull-base tumors.
Based on points acquired inside the resection cavity, Elements Intraoperative Structure Update captures residual tumor volumes, and an intuitive traffic light display offers comprehensive information about tumor coverage and critical dose constraints for calculated treatment plans.
Automatic Brain Metastasis Planning software helps clinicians to plan and treat multiple brain metastases with time and dose efficiencies while helping to minimize exposure to healthy surrounding tissue.
Brainlab president and CEO Stefan Vilsmeiern 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."
Established in 1989, Brainlab has installed around 5,000 systems installed in about 95 countries.
Image: Brainlab sets new benchmark in treatment of multiple brain metastases. Photo: courtesy of Business Wire.