Avenda Health announced that it received FDA investigational device exemption (IDE) for its FocalPoint ablation system power by iQuest. The IDE will allow Avendra to combine the two technologies in a randomized, controlled trial to show superiority over the standard of care for the treatment of prostate cancer. iQuest uses artificial intelligence (AI) and deep […]
Avenda Health
Avenda Health wins FDA breakthrough nod for AI-based prostate cancer treatment
Avenda Health announced today that it received FDA breakthrough device designation for its AI-based male “lumpectomy” product. Santa Monica. Calif.-based Avenda designed its lumpectomy product to treat prostate cancer in-office while preserving the quality of life through AI and minimally invasive technologies, according to a news release. The Avenda Health focal therapy system spares healthy […]
Avenda Health focal laser ablation system wins FDA clearance
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 […]
Funding Roundup: Swiss Advanced Vision seeks $21m for auto-focus IOL
Funding Roundup A clutch of medical device companies raised cash to fund their operations, includingAscentX Medical, Avenda Health, Global Kinetics, Nephros, OrthoSensor and Swiss Advanced Vision. Here’s a look at them, their technologies and how much they drummed up. Next >>