SeeTreat's ART.1-US Software is FDA Cleared for clinical use in the USA

SYDNEY, May 18, 2026 /PRNewswire/ --

SeeTreat's ART.1-US software delivering automated adaptive decision support for every patient at every treatment is cleared for use in the USA. From today, US clinics with Varian or Elekta CT linear accelerators, will be able to access daily evaluations of radiotherapy dose to patients' changing anatomy. With ART.1-US, clinical teams can now decide the right time for a new radiotherapy plan in 95+ seconds¹, and download supporting clinical documentation.

SeeTreat has been working with seven large US networks on early access and research programs in the USA. We are pleased that these groups will now be able to use ART.1-US clinically as well as for their research programs.

“Having piloted a research version of SeeTreat's ART.1 software, our team has seen how automated adaptive decision support can help clinical teams efficiently evaluate whether anatomic changes during radiotherapy are dosimetrically consequential throughout a patient's treatment course. This type of structured, dosimetry-based assessment can support evidence-based replanning decisions. With ART.1-US advancing to an FDA-cleared product for clinical use, it brings the potential to support broader implementation of personalized adaptive radiotherapy.”

— Professor Jeff Siebers of the University of Virginia

“This is a landmark moment for the SeeTreat team. FDA clearance of ART.1-US brings our intelligent adaptive radiotherapy solution to the single largest radiotherapy market in the world, extending our reach beyond the UK, Europe, and Australia. As we pursue our mission of equitable access to highly personalised radiotherapy, this milestone marks a new chapter in scaling ART.1 globally. We look forward to partnering with US clinics to unlock the full potential of offline adaptive radiotherapy for the benefits of US cancer patients.”

— SeeTreat CEO and Founder, Dr Trang Nguyen

SeeTreat's ART.1 software has UKCA mark, CE mark and Australian TGA ARTG registration. ART.1-US has FDA 510k Clearance.

¹ Pollock, et al. "Resource Optimisation in Adaptive Radiotherapy: Introducing ART.1 To Accelerate and Optimise Workflows." White Paper (2025)

About SeeTreat

SeeTreat is doctor backed, physics led, software medical device company founded in 2023, led by Dr Trang Nguyen, Antonia Dalton and Professor Paul Keall. Our vision is to reduce the burden of cancer through broadly accessible software improving quality and accuracy of treatment. SeeTreat is a global company with a current install base in the UK, Europe, USA and Australia.

For more information visit https://www.seetreatmedical.com/ and follow SeeTreat on LinkedIn https://www.linkedin.com/company/seetreat-medical