VBrain has been evaluated at multiple sites across the US and Taiwan before FDA approval
Vysioneer has secured approval from the US Food and Drug Administration (FDA) for its VBrain artificial intelligence (AI) powered tumour auto-contouring solution for radiation therapy.
VBrain is claimed to be the first AI device for tumor auto-contouring in radiation therapy.
Developed to improve the radiotherapy treatment planning, the solution facilitates a quicker response time to conduct radiation therapy with more precision in targeting the tumour.
VBrain allows completing the contouring time within a few minutes, while it may take several hours by clinicians when conducted manually.
The fully automated solution also supports the precision mapping of brain tumors with closer cuts, as well as enables the detection of additional lesions that may be missed by the human eye.
Vysioneer CEO Jen-Tang Lu said: “Receiving unique FDA clearance for this solution allows Vysioneer to further its commitment of transforming radiotherapy workflows through developing full body auto-contouring solutions.
“The future of AI is near, bringing a second set of eyes and hands to assist clinicians in analyzing and segmenting medical scans and further improving patient cancer care.”
Vysioneer stated that VBrain has been evaluated at multiple sites across the US and Taiwan before FDA approval.
The approval allows using the AI solution to apply auto-contouring to the three most common types of brain tumours such as brain metastasis, meningioma and acoustic neuroma.
Vysioneer has also tested the device through an 18-month clinical integration at National Taiwan University Hospital (NTUH).
According to the company, clinical findings showed that clinicians assisted by VBrain demonstrated 12.2% higher sensitivity for lesion detection and less experienced clinicians improved contouring accuracy with the added help.