Botkin.AI Platform Gains CE Certification in Europe

The Botkin.AI platform, a high accuracy, AI-based solution for analyzing medical images (CT scans, mammograms, and digital X-rays), has received the CE mark. CE certification will allow Intellogic, the company behind Botkin.AI, to export the platform to the EU and other countries, where it can now be used as a medical device.

Botkin.AI is the first Russian-made, AI-based medical analysis solution to receive the much sought-after CE mark, which opens up the EU’s 27 markets as well as a number of other countries around the world. Botkin.AI is designed to help oncologists and radiologists analyze medical images and ensure quality control in radiological diagnostics, including CT scans, X-rays, and mammograms. CE certification will allow it to be adopted into everyday medical practice abroad.

Intellogic is now expected to begin a number of international projects aimed at implementing Botkin.AI into healthcare abroad. One of the next steps for the company is to open up the US market by gaining FDA approval for the platform.

Sergey Sorokin, CEO of Intellogic (Botkin.AI). Photo: Sk.ru.

“Getting the CE mark is an important part of our development strategy,” said Sergey Sorokin, Intellogic’s CEO. “The process, such as preparing application papers as well as getting through each examination stage, took a long time and required serious preparation on the part of our team. We were the first in Russia to do this, which proved difficult at every stage of the certification process. On the other hand, it is very nice to be trailblazers again. It is also important for us to show our esteemed clients in Russia and abroad that our product meets all stringent quality standards. I would like to express my thanks to our esteemed European colleagues and our fantastic team, who helped during the registration process. With European certification, we are planning large-scale development both in Europe and elsewhere, not forgetting, of course, about implementing our successful projects in Russia.”

Botkin.AI is a comprehensive AI/IT product with which medical practitioners can conduct research analysis, visualize results and manage the research flow. The platform has its own patented technologies for the creation, renewal, and management of mathematical models designed for analyzing medical information.

Sergey Voynov, the head of Digital Health at the Skolkovo Foundation biomedical technologies cluster, said in a statement to Sk.ru that the foundation has supported Intellogic for the last three years — almost since its inception. In 2020, Botkin.AI became the first product using artificial intelligence for medical image analysis to receive certification from Roszdravnadzor (Federal Service for Surveillance in Healthcare); this allowed the platform to be adopted into general medical practice within Russia. CE certification has expanded the territory in which Botkin.AI, the first certified AI-based software product to come out of Russia, can operate and is crucial to Intellogic’s international development strategy.