The FDA granted 510(k) clearance to Unfold AI, which was formerly known as iQuest, in December 2022.
Unfold AI, an artificial intelligence (AI)–powered software application program for the management of patients with prostate cancer, is being used with patients for the first time in a commercial setting, according to Avenda Health, the developer of the technology.1
"I am hopeful that Unfold AI will be to intraprostatic staging what prostate-specific membrane antigen PET-CT has been for extraprostatic staging,” stated Wayne Brisbane, MD, an assistant professor of urology at UCLA Health, and one of the initial physicians using the technology, in a press release.
The FDA granted 510(k) clearance to Unfold AI, which was formerly known as iQuest, in December 2022.2 Physicians are now using the technology to work with patients on treatment selection and establishing an optimal overall management plan.
According to Avenda, Unfold AI “combines patient-specific data from prostate imaging, biopsies, and pathology into deep-learning algorithms to create a unique and tailored cancer estimation map. Its 3D, AI-generated map visualizes the location of the cancer for physicians to use in treatment decision making and interventional planning.”
"With a wide breadth of ablative options available, Unfold AI represents the first technology to improve tumor localization and patient selection," noted Brisbane.
Avenda reported in the release that Unfold AI has been validated in multiple clinical studies. For example, clinical data shared during the 2022 American Urological Association (AUA) Annual Meeting showed that Unfold AI improved the establishment of tumor margins over conventional treatment planning from 56 percent to 80 percent.3
"This is a major step forward for the prostate cancer community and we are beyond thrilled to see a decade of hard work and research pay off," Leonard Marks, MD, co-founder and chief medical officer of Avenda Health, stated in a press release. "Our mission at Avenda Health is to create a better quality of life for prostate cancer patients and to give urologists a clearer view of the cancer so we can better treat our patients. Unfold AI will improve clinical care and decision making."
1. Avenda Health. Avenda Health announces first commercial use of Unfold AI on prostate cancer patients in the U.S. Cision PR Newswire. Available at: https://www.prnewswire.com/news-releases/avenda-health-announces-first-commercial-use-of-unfold-ai-on-prostate-cancer-patients-in-the-us-301806285.html . Published April 25, 2023. Accessed April 27, 2023.
2. Hall J. Could an emerging AI platform supplant traditional MRI for assessing prostate cancer? Diagnostic Imaging. Available at https://www.diagnosticimaging.com/view/could-an-emerging-ai-platform-supplant-traditional-mri-for-assessing-prostate-cancer- . Published December 7, 2022. Accessed April 27, 2023.
3. Avenda Health. Avenda Health receives FDA Investigational Device Exemption for AI-enabled prostate cancer therapy. Cision PR Newswire. Available at: https://www.prnewswire.com/news-releases/avenda-health-receives-fda-investigational-device-exemption-for-ai-enabled-prostate-cancer-therapy-301602061.html . Published August 9, 2022. Accessed April 27, 2023.