Avenda Health announced that it received FDA investigational device exemption (IDE) for its FocalPoint ablation system power by iQuest.
The IDE will allow Avendra to combine the two technologies in a randomized, controlled trial to show superiority over the standard of care for the treatment of prostate cancer.
iQuest uses artificial intelligence (AI) and deep learning to map prostate cancer and provide physicians with a precise location of cancer within the gland, plus a better understanding of the extent of the disease to help with treatment planning.
According to a news release, a retrospective study of 50 patients demonstrated that iQuest improved tumor margin creation over conventional treatment planning from 56% to 80%.
California-based Avenda designed its FocalPoint laser ablation system to treat localized prostate cancer in-office while preserving quality of life. Avendra’s system received FDA breakthrough device designation last yea…