With the approval, the firm’s FocalPoint ablation system powered by iQuest can now be used in a randomised control trial to advance prostate cancer research
FDA Building 66. (Credit: The U.S. Food and Drug Administration/ Wikipedia)
AI healthcare company Avenda Health has received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) for its FocalPoint ablation system.
The FocalPoint ablation system is powered by a patient management AI software, iQuest.
With the approval, the firm’s FocalPoint ablation system can now be used in a randomised control trial to advance prostate cancer research and demonstrate its superiority over standard treatment, said the company.
According to the firm, iQuest uses deep learning and artificial intelligence to map a patient’s prostate cancer.
It helps to deliver a clear picture of the degree of the disease and an exact location of cancer within the gland to help with treatment planning.
In a retrospective study of 50 patients presented at the American Urological Association annual meeting presentation, iQuest increased tumour margin creation over traditional treatment planning from 56% to 80%.
Avenda Health co-founder and CEO Dr Shyam Natarajan said: “Our mission is to advance prostate cancer therapy so patients no longer need to choose between treatment or quality of life.
“Using the latest deep learning technology, iQuest gives physicians and their patients more insights to identify the best treatment on an individual basis.
“We’re thrilled to receive IDE approval so we can further prostate cancer research for the millions of men affected each year.”
Avenda Health’s FocalPoint-focused laser ablation system is intended to treat locally advanced prostate cancer while maintaining the quality of life.
The FDA awarded Avenda Health with a Breakthrough Device Designation in 2021, signifying a strong probability that the Avenda Health technology will outperform the industry norm.
The FocalPoint technology re-imagines laser ablation and makes it possible to treat prostate cancer in a doctor’s office without an MRI with ultrasound guidance, said the company.