Avenda wins FDA IDE nod for AI-enabled prostate cancer therapy

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…

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Avenda Health wins FDA breakthrough nod for AI-based prostate cancer treatment

Avenda Health announced today that it received FDA breakthrough device designation for its AI-based male “lumpectomy” product.

Santa Monica. Calif.-based Avenda designed its lumpectomy product to treat prostate cancer in-office while preserving the quality of life through AI and minimally invasive technologies, according to a news release.

The Avenda Health focal therapy system spares healthy tissue and minimizes side effects while using patient-specific information and AI to offer a precise and personalized treatment that targets only the tumor. The procedure can be performed in a physician’s office with local anesthesia alone, minimizing downtime and potentially reducing the cost to the healthcare system, the company said.

Avenda, a spinout of UCLA with support from a National Cancer Institute grant, conducted a Phase 1 study on 10 patients. That study recently completed enrollment and has demonstrated safety and no decline in urinary…

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