Avenda Health today received FDA 510(k) clearance for its focal laser ablation system.
The image-guided focal laser ablation system is designed to ablate soft tissue in a physician’s office. It features a laser needle and thermal optical sensor to target and treat soft tissue while minimizing the impact on healthy tissues.
“We purposely designed our therapy system to be simple and intuitive to use in a physician’s office. Given the current strain on the healthcare system due to COVID-19, we believe it is vital for more therapies to move from the hospital setting to an office-based procedure,” cofounder and COO Brittany Berry-Pusey said in a news release.
“This device is backed by over a decade of research. With our first FDA clearance, we are now able to offer this revolutionary technology to patients and will quickly be following up with additional technologies from our pipeline including an investigational version that is being used in clinical trials for the treatment of intermediate-risk prostate cancer,” cofounder and CEO Shyam Natarajan said.