FDA Clears Avenda Health’s AI-Powered Prostate Cancer Care Platform

Avenda Health, an artificial intelligence (AI) company developing tools for personalized prostate cancer care, has achieved 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its iQuest cancer management platform.
 
iQuest leverages patient-specific diagnostic information and deep-learning algorithms to generate a tailored map of locations of cancer within the prostate, allowing physicians to make decisions that consider the cancer extent instead of treating the entire organ.
 
The information supports treatment selection, planning, guidance, and follow-up.
 
“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,” Dr. Shyam Natarajan, co-founder and CEO of Avenda Health told the press. “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.”
 
In one study, urologists improved sensitivity of identifying tumor extent by using iQuest from 37% to 97% and changed treatment recommendation in 27% of cases, with the most significant change toward a more localized treatment.
 
iQuest can be applied to various treatments to guide an intervention plan, including Avenda’s FocalPoint soft tissue laser ablation device, and other focal treatments, active surveillance, and decision-making for whole gland treatments.
 
“At the heart of what we do is the belief that patients should never have to choose between quality of life and cancer control,” said Dr. Brittany Berry-Pusey, co-founder and COO of Avenda Health. “By providing a personalized cancer map, iQuest opens the door for more precise treatments. This clearance will go a long way not only for our company but for the future of prostate cancer care.”
 
Avenda also recently raised $10 million in Series B funding to accelerate iQuest’s use and continue development of clinical evidence.