Niranjani Komethagavel, AI/ML Regulatory Engineer

Niranjani Komethagavel

AI/ML REGULATORY ENGINEER

Joined: August 17, 2026

Summary

I helped build two AI models, one at 93% recall on pancreatic whole slide images, one predicting rupture on a 1,065-patient brain AVM registry, and now support 510(k) submissions. I earned an M.S.E. in biomedical engineering from Johns Hopkins in 2026 with a focus on AI in healthcare, and I joined Innolitics as an AI/ML Regulatory Engineer to carry clinical AI from validated prototype to FDA clearance. I currently contribute to a 510(k) submission for a medical image viewing device. Before Hopkins I built a healthcare chatbot with retrieval-augmented generation as a data scientist at Mindsprint and did wet-lab immuno-oncology research at Harvard Medical School and Brigham and Women's Hospital, so I can hold both the clinical and the engineering side of a regulatory conversation.

Skills

Machine Learning Deep Learning Medical Imaging LLMs/RAG Python

Bio

I helped build two AI models, one at 93% recall on pancreatic whole slide images, one predicting rupture on a 1,065-patient brain AVM registry, and now support 510(k) submissions. I earned an M.S.E. in biomedical engineering from Johns Hopkins in 2026 with a focus on AI in healthcare, and I joined Innolitics as an AI/ML Regulatory Engineer to carry clinical AI from validated prototype to FDA clearance. I currently contribute to a 510(k) submission for a medical image viewing device. Before Hopkins I built a healthcare chatbot with retrieval-augmented generation as a data scientist at Mindsprint and did wet-lab cancer research at Harvard Medical School and Brigham and Women's Hospital, so I can hold both the clinical and the engineering side of a regulatory conversation.

Hobbies

Art, Reading, Chess, Perfumery