Avenda Health received FDA 510(k) clearance for AI-backed clinical decision support software that assists physicians in prostate cancer care.
iQuest, which officially received the agency green light late last month, is meant to be used alongside MRI and biopsy results. The system uses specific patient data and deep learning to build a “tailored map” showing where cancer is located in the prostate.
According to the 510(k), the tool helps physicians segment MRI features, evaluate lesions and plan ahead for surgeries and biopsies. Avenda pitches the tool as a way to lessen the likelihood of reduced sexual or urinary function after treatment.
“We are excited about the potential to unlock precision care in prostate cancer with iQuest, as it is a key enabling technology for focal therapy to be a reality for urologists and patients,” said Dr. Shyam Natarajan, cofounder and CEO of Avenda Health.
“In order for a doctor to treat focally, they need to know where cancer is and the healthy tissue to avoid. This is vital information that iQuest now provides. This is a huge step forward in transforming the standard of care in prostate cancer and brings us that much closer to offering effective therapy that preserves quality of life to providers and patients across the U.S.”
THE LARGER TREND
The clearance marks the second 510(k) for Avenda, which was spun out from UCLA in 2017. The company first received FDA clearance for a focal laser ablation system in 2020.
Earlier this year, Avenda raised $10 million in a Series B funding round led by VCapital. The company also announced it had received an investigational device exemption (IDE) from the FDA for its FocalPoint ablation system that’s designed to be used in conjunction with iQuest.
An IDE allows a device to be used in an investigational study to collect safety and effectiveness data. The study is most often conducted to support premarket approval for Class III medical devices. In August Avenda said it will use the IDE to conduct a randomized controlled trial to evaluate using the two products against standard care for prostate cancer.
Original Article: (https://www.mobihealthnews.com/news/avenda-health-receives-fda-clearance-ai-support-software-prostate-cancer)