Cratia Receives Regulatory Approval for Radiobotics’ RBfracture in Ukraine

We are pleased to share that Cratia, in its role as regulatory-affairs partner and authorised representative, has contributed to a significant milestone in Ukraine’s medical-device market. A key international MedTech company has today announced regulatory approval for its AI-powered trauma-imaging solution in Ukraine — a major step forward in improving diagnostic care and strengthening our country’s access to advanced medical technologies.

Below is the full release, originally published by the manufacturer, which explains the scope of the registration, the Finnish-Danish company’s global footprint, and our collaborative role in enabling this market entry.

Original text: https://radiobotics.com/press-release/radiobotics-receives-regulatory-approval-for-rbfracture-in-ukraine/ 

Radiobotics Receives Regulatory Approval for RBfracture in Ukraine

This milestone expands Radiobotics’ global footprint to over 44 countries and supports clinicians in reducing missed fractures and avoiding the unnecessary review of false positives in both adult and paediatric patients.

November 04, 2025 — Radiobotics, a leader in AI-powered musculoskeletal (MSK) radiology solutions, is pleased to announce that RBfracture™ has received regulatory approval for market access in Ukraine.

This milestone expands Radiobotics’ global footprint to over 44 countries and supports clinicians in reducing missed fractures and avoiding the unnecessary review of false positives in both adult and paediatric patients.

Addressing Ukraine’s Growing Need for Rapid MSK Imaging

Ukraine faces a high and growing demand for rapid, accurate MSK imaging due to increased trauma caseloads, postconflict injury burden, and a stretched radiology workforce.

Radiobotics expects their flagship solution, RBfracture™, will help reduce missed fractures, speed up clinical decision making and extend specialist diagnostic capacity to regional hospitals and outpatient centres where radiologists and resources are limited.

Efficient Regulatory Approval and Localisation

The Ukrainian approval was achieved in a notably shorter timeframe compared to many international registrations, thanks to an efficient review process and strong collaboration with Radiobotics’ authorized representative Cratia.

The process required extensive translation and localization work, including updates to the Instructions for Use (IFU), labelling, and technical documentation. Cratia also supported the transliteration of product and company names into Ukrainian, resulting in RBfracture being registered as “РБфрактуре” and Radiobotics ApS as “Радіоботікс АпС.”

“This technology can be especially valuable for patients arriving with severe or complex injuries, including people hurt in military or wartime conditions. When every minute matters, RBfracture helps teams prioritise urgent cases and ensures even small fractures are not overlooked. It offers an extra layer of support for doctors working under pressure, helping patients get the right treatment sooner,” explained Maksym Bagrieiev, CEO of Cratia.

Distribution in Ukraine

Radiobotics is represented in Ukraine by Next Level Diagnostics (NLD), a USBritish distributor and one of the country’s leading diagnostic solutions providers.

“Entering Ukraine marks another important step in our vision to ensure patients receive immediate and precise, expert-level care in MSK imaging, 24/4, regardless of time, infrastructure, or staffing constraints,” said Peter Ulvskjold, CEO of Radiobotics. “We’re especially grateful to our partners for helping us navigate the requirements so efficiently, ensuring RBfracture is ready for clinicians who need it.”

With Ukraine now added to the growing list of approved markets, Radiobotics expands its worldwide availability and impact.

About Cratia

Cratia Ltd. is a group of companies providing professional regulatory services for registration (marketing authorisation), safety, and quality management of medical products in 12 countries of the CIS region (Eastern Europe and Central Asia): in Azerbaijan, Armenia, Georgia, Kazakhstan, Moldova, Mongolia, Tajikistan, Turkmenistan, Uzbekistan, and Ukraine.

Learn more at: www.cratia.com

 About Next Level Diagnostics

Next Level Diagnostics (NLD) is a USBritish diagnostics distributor and authorised Radiobotics partner operating across Ukraine. NLD is a major supplier to the Ministry of Health of Ukraine and has delivered large-scale medical equipment programmes, turnkey installations and regulatory support for clinical devices.

NLD has established experience working with international organisations and donors, including the UN, UNICEF, the Clinton Foundation, Culmen International, GAFFI and LIFE. Its crossfunctional capability covers procurement and customs clearance, onsite installation, engineering and calibration, clinician training, and dedicated customer support and maintenance teams deployed nationwide.

Learn more at www.nextleveldiagnostics.com

About Radiobotics

Founded in 2017, Radiobotics is an award-winning Danish MedTech company dedicated to advancing musculoskeletal (MSK) radiology with AI-powered solutions. Radiobotics’ flagship solution, RBfracture™, is designed to support Emergency and Radiology with highly accurate detection of trauma-related findings, including fractures, dislocations, lipohemarthrosis, and effusion.

Radiobotics’ commitment to delivering precise, expert-level care in MSK imaging 24/7, regardless of time, infrastructure, or staffing constraints, has been recognized in the industry with numerous accolades, including winning the SBRI Healthcare Competition to support the NHS A&E, NICE approval for urgent care settings across the NHS, and Best New Radiology Vendor at the EuroMinnies 2022.