TheraPanacea receives FDA (510K) clearance for ART-PlanTM: its AI-powered contouring and image fusion tool
TheraPanacea, an award-winning French med-tech company founded in 2017, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its deep-learning software ART-PlanTM – the first fully powered radiation oncology solution for efficient and standardized cancer treatment planning.
The aim of radiotherapy is to increase the dose delivered to the tumor whilst minimizing surrounding organ damage. during radiotherapy planning, clinical staff need to identify and accurately delineate tumors as well as organs at risk. If organs are not properly delineated, the radiation plan may not protect these critical structures or adequately treat the tumor, leading to increased toxicity and potentially poorer outcomes for patients. Most of this important task is performed in a manual manner, which is not only highly time-consuming but also subject to expert variability and experience.
To overcome these challenges, TheraPanacea has developed an artificial intelligence (AI) guided software, ART-PlanTM for radiotherapy planning. TheraPanacea’s ART-PlanTM uses Deep Learning, a form of AI technology, to fully speed-up and standardize the contouring of organs at risk and lymph nodes as well as to enable high-precision rigid and elastic fusion for faster replanning. By combining the power of AI with the collective intelligence of world wide experts, ART-PlanTM automatically generates clinically acceptable contours for all anatomies (80+ OARs) in a few minutes instead of hours of human time.
ART-PlanTM is already used in the clinical workflow of more than 30 leading European centers, who are already benefiting from exceptional time savings, optimized human resources, and standardized treatment planning workflow. Users in Europe have reported to save up to 90% of the time required for these tasks.
“Artificial intelligence is a game changer in medicine. We are thrilled and humbled to the FDA for authorizing ART-PlanTM’s deployment in record time to enable optimized treatment outcomes, standardized treatment and reduced treatment costs to US clinics and patients”, says Prof Nikos Paragyios, founder and CEO of TheraPanacea. “This clearance paves the way for extraordinary research and disruptive innovations with the added value of enabling us to benefit from expertise and experience from the most innovative healthcare ecosystem”.
About TheraPanacea: A medical technology company created in 2017, TheraPanacea develops top-notch software for smarter cancer diagnosis, prognosis, and treatment. TheraPanacea’s first software for radiotherapy, ART-Plan ™, has been available on the European market since 2019. Since its creation, TheraPanacea has won prestigious distinctions and prizes including the European Research Council (ERC) Proof of Concept Grant (2016), the Digital Innovation Competition (BPI), the Grands Prix d’Innovation de la Ville de Paris in Health category (2017), the 1st AI Challenge prize for the Paris region (2018) and the H2020 – SME Instrument Phase 2 prize (2019) rewarding the most disruptive European companies in their market.
