David Odrakiewicz.
Chief Executive Officer, MedApp S.A.
“CarnaLife Holo exists because a surgeon should not have to assemble a patient's three-dimensional anatomy in their head out of flat slices. The product is FDA cleared and fully compliant with the European MDR — that stage is behind us. Today our key direction is computer vision and Physical AI: models that understand the scene of a procedure and turn that understanding into safe device motion. We are building the company around exactly that capability.”
- 2015
- Building medical software since
- MDR IIa
- CarnaLife Holo medical device class
- FDA · MDR
- Clearances obtained for the US and the European Union
Our vision.
We want medical images to be understood, not merely viewed. A patient's anatomy is three-dimensional, and a clinical decision is made in seconds. We build systems that see and interpret the image: showing the body as it truly is — in space, at one-to-one scale — catching what is easy to miss, and guiding the operator's hand. The same ability to see underpins our medical devices and the computer vision and Physical AI solutions we build for machines and robots.
Our mission.
We strengthen medicine with technology that can be trusted. We combine computer vision and Physical AI with the medical device rigour we know from CarnaLife Holo: validation, documentation and a quality system. Technology reaches the operating room only once we can prove it is safe.
Three pillars, one direction.
A product already working at the patient's side. FDA and MDR clearances already behind us. And computer vision — the direction in which we are growing the company today.
- Product
CarnaLife Holo — a hologram instead of a flat screen
We turn CT and MR imaging into a three-dimensional hologram the surgeon looks at in the operating room and controls with a gesture, without touching anything. Our software has accompanied cardiac, oncological and vascular procedures in more than a dozen centres.
Explore CarnaLife Holo - Regulatory
FDA and MDR — a closed chapter
CarnaLife Holo is FDA cleared for the US market and fully compliant with the European MDR. We apply the same rigour — validation, clinical documentation and a quality management system - to every new feature, including the ones driven by artificial intelligence.
Ask for details - Technology
Computer vision and Physical AI
We deploy the latest generation of vision models — the NVIDIA Cosmos and Isaac GR00T families — where a decision has to become safe motion: in medical devices and robotic systems. Every action passes through a deterministic safety layer and is logged.
See our services
The people behind it.
Clinicians, engineers and capital market executives — the senior management team taking the product through operating rooms and regulated markets, and the supervisory board watching over the company's governance.
Meet the leadership team
Cleared where it counts.
Our software has been through the regulatory pathways on MedApp's key markets — from the CE mark in the European Union, through Brazil's ANVISA and the US FDA, to the NATO NCAGE code.
- European UnionCE
CarnaLife Holo and CarnaLife System in facilities across the EU.
- BrazilANVISA
CarnaLife Holo certified for the Brazilian market.
- United StatesFDA
Confirmation of compliance obtained in May 2023.
- NATO OTANNCAGE
Deliveries and services for NATO member states.
Let's talk about what we can build together.
Hospitals, medical device manufacturers, research teams and investors — we speak to all of them in the same language: specifics.