Avenda Health has been awarded Breakthrough Device Designation for a male “lumpectomy” product in development designed to treat prostate cancer in-office while preserving quality of life.
Breakthrough Device Designation by FDA is reserved for devices that are potentially transformative, offering treatment for serious diseases that may be more effective than currently available treatments. Avenda Health is a California-based software and medical device company aiming to improve cancer outcomes through artificial intelligence (AI) and minimally invasive technologies.
Precise and Personalized Treatment
Prostate cancer is one of the most common cancers, with one in eight men developing it in their lifetime.1 Prostate cancer is traditionally treated by surgery or radiation, which have well-known side effects such as urinary, sexual or bowel dysfunction. The Avenda Health Focal Therapy System, which is designed to spare healthy tissue and minimize side effects, uses patient-specific information and AI to deliver a precise and personalized treatment, targeting only the tumor. This treatment can be performed in a physician’s office with just local anesthesia, minimizing the patient’s downtime and potentially reducing cost to the healthcare system.