Charu User

I’m a founder and medical AI executive with 7+ years building AI-powered diagnostic systems from concept through clinical trial. I bring a rare combination of deep technical depth and clinical commercial experience.

I’ve personally architected and shipped end-to-end computer vision systems across dermatology and bladder cancer—covering model development, edge hardware deployment, and hospital integration. I designed an end-to-end real-time cystoscopy detection system targeting carcinoma in situ (CIS), with a unified model plus 3D spatial mapping and temporal reasoning running at 30fps on edge hardware.

On the regulatory and clinical side, I lead FDA regulatory strategy and clinical trial design. I completed an FDA pre-submission meeting confirming the De Novo pathway and CADe/CADx classification for a novel AI-assisted cystoscopy device with no predicate, and I built a clinical trial network spanning the US, Europe, the Middle East, and Asia-Pacific—securing IRB approval at the first investigational site.

Operationally, I make products that hospitals can actually adopt. I implemented a plug-and-play hardware system integrating Jetson Orin Nano with hospital cystoscopy towers (compatible with Storz, Olympus, and Ambu), partnered with Healthgrades for AI-based skin cancer screening to 1.1 million consumers, and led fundraising through venture capital and state grants while managing an active seed round.