Vysioneer receives FDA clearance for tumour auto-contouring solution 

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Vysioneer, a provider of artificial intelligence (AI) for cancer care, has received clearance from the US Food and Drug Administration (FDA) for VBrain. In a press release, the company claims that this is the first-ever AI-powered tumour auto-contouring solution.

According to Vysioneer, VBrain will enable a quicker response time for performing radiation therapy with more precision in targeting the tumour. The fully automated solution also ensures precision mapping of brain tumours with closer cuts and the ability to identify additional lesions that may be missed by the human eye. This is the first time the FDA has cleared an AI device for tumour auto-contouring in radiation therapy, reports the company.

The press release reports that the VBrain was tested across multiple sites throughout the US and Taiwan to receive this clearance. The solution is cleared to apply auto-contouring to the three most common types of brain tumours: brain metastasis, meningioma and acoustic neuroma. 

These studies found that clinicians assisted by VBrain demonstrated 12.2% higher sensitivity for lesion detection, and less experienced clinicians improved contouring accuracy with the added help. The efficiency in AI assistance also decreased treatment planning time at a median of 30.8%. “There were distinct accuracy and efficiency improvements for clinicians of all skill levels,” says Jason Chia-Hsien Cheng, former director of radiation oncology at the National Taiwan University Hospital, Taipei City, Taiwan. “VBrain has a unique opportunity to influence future treatment on a global scale as cloud-based software. Clinicians around the world, including areas lacking in resources, could utilise VBrain to achieve the world class standard of contouring.”

“I am thrilled to bring VBrain to our partners across the US and Taiwan,” says Jen-Tang Lu, CEO of Vysioneer. “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 analysing and segmenting medical scans and further improving patient cancer care.”


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