Christoph Götz
Co-founder and COO, ImageBiopsy Lab · PhD
Taking detection AI from model to regulated clinical product, and on to reimbursement.
As COO, quality management representative and PRRC, I lead regulatory strategy, quality, clinical evidence and market access for nine cleared AI products in musculoskeletal and osteoporosis imaging. Before that, as CTO, I built the company’s AI foundation.
Results of the regulatory, evidence and market-access work I lead
- 7CE and FDA clearances across 9 products
- NICEconditional recommendation for the NHS, 2025
- ~60peer-reviewed studies on the products, most by independent groups
- 12technical files under my approval as PRRC
01 Work
One system, from model to reimbursement
Most medical AI dies in the gap between “the model works” and “someone pays for it in the clinic.” My job is to close that gap: evidence, regulatory class, IP and the payer pathway, planned as one system instead of handed between departments.
- Model
As CTO, built the AI foundation behind the first four CE-marked products (2019 to 2020).
- Evidence
Co-author of nine papers; the portfolio carries about 60 peer-reviewed studies, mostly independent.
- Regulatory
Seven clearances, twelve technical files, ISO 13485 since 2018, PRRC for the portfolio.
- IP
Named inventor on European and US patent applications for the products.
- Reimbursement
Led the NICE and Swedish assessments as named contact, wrote the NICE application, and lead the payer talks in Germany.
Roles
- 2019 – todayCo-founder and COO
ImageBiopsy Lab, Vienna. Regulatory strategy, quality, clinical evidence, market access and partnerships. Quality management representative and PRRC since 2023.
- 2017 – 2019Co-founder and CTO
ImageBiopsy Lab, Vienna. Training architecture, custom loss functions and the model pipeline behind the first four CE-marked products.
- 2022PhD Quantum Biology, with distinction
Universität Wien, research 2010 to 2016 at IMP/MFPL: quantum and vibrational effects in biological function, whole-brain calcium imaging.
Milestones
- 2026Swedish national assessment
MTP-rådet, Sweden
- 2025NICE conditional recommendation for the NHS
HTG760, United Kingdom
- 2023CE mark for IB Lab FLAMINGO
Detection of vertebral fragility fractures in osteoporosis
- since 2019
Rigor over hype. Systems over tools. Traceability over black boxes.
Not good for: unnecessary meetings, or “that’s how it’s always been done.”
02 Writing
Writing on AI that has to be trusted
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SciSpy: semantic search over 100,000 papersBuilt in 2016 with word embeddings, years before “semantic search” was a product category.
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How do you regulate a system whose abilities emerge unpredictably?2023: what medical device regulation already knows about testing, surveillance and post-market follow-up, applied to chatbots.
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Testing a chatbot against my own PhD thesisAn early retrieval-augmented setup, checked question by question for where it is right and where it makes things up.
03 Talks
Where I’ve been talking
- 2026MSc Regenerative Medicine
Krems, Austria
- 2025 – 2026MedicalMountains AI Act seminars
- 2024TÜV SÜD medical.device.forum
Munich, Germany
- 20248. MDR-Forum
- 2023DGMSR Highlight Lecture
Charité, Berlin, Germany
- 2019RSNA Annual Meeting
Chicago, USA
- OngoingGuest lecturer
FH Technikum Wien, Vienna, Austria
Get in touch
hello@christophgoetz.comTalks, collaborations, or a good conversation about regulated AI.