---
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.
credentials: []
hire_date: '2026-08-17'
hobbies: Art, Reading, Chess, Perfumery
linkedin: https://www.linkedin.com/in/niranjani-k/
name: Niranjani Komethagavel
order: null
photo: /img/people/Niranjani_Komethagavel-3bbbd5b7a754804487aee9b954eecd55.jpg
skills: Machine Learning, Deep Learning, Medical Imaging, LLMs/RAG, Python
suffix: []
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.
testimonials: []
title: AI/ML Regulatory Engineer
---