MVision AI Secures FDA 510(k) Clearance for Contour+ Advanced CT and MR Models

Helsinki, October 2024 – MVision AI, a leading innovator in AI-powered solutions for radiotherapy, is thrilled to announce that its auto-contouring solution Contour+ has received FDA 510(k) clearance for three new models: Bones CT, Brain MR, and Male Pelvis MR T2, and five updated models: Brain CT, Abdomen & Lung CT, Breast CT, Female Pelvis CT, and Male Pelvis CT.

With this significant milestone, Contour+ models now support a total of 159 organs-at-risk and 67 lymph node regions in the U.S. market, enabling a comprehensive range of auto-contouring capabilities to meet the demands of modern radiotherapy departments.

New Models Available in the U.S.

  • Brain MR: Supports MR-based contouring of 29 OARs in the brain area, adhering to the EPTN recommendations. This model ensures more precise sparing of sensitive nervous and cognitive tissues, including key structures like the Hippocampus, Cerebellum, Brainstem (Midbrain, Pons, MedullaOblongata), and the optic apparatus (from eye globes to optic tracts).
  • Male Pelvis MR T2: Tailored for prostate cancer treatment planning, this model brings highly detailed MR-based contouring to aid in more accurate radiotherapy planning.
  • Bones CT: Extends Contour+’s SBRT applications by offering independent vertebrae and rib delineation, particularly for palliative radiotherapy care. 

Updated Models for the U.S. Market

  • Brain CT, Abdomen & Lung CT, Breast CT, Female Pelvis CT, Male Pelvis CT: These five models have been updated with enhanced performance and new features, such as the addition of lymph node (LN) and clinical target volumes (CTV) starting points based on leading guidelines including RTOG and RADCOMP.
  • For example, the Male Pelvis CT model incorporates a new LN following “Hall et al 2020, NRG Oncology Updated International Consensus Atlas on Pelvic Lymph Node Volumes for Intact and Postoperative Prostate Cancer”. The Female Pelvis CT model includes LN and pelvic CTV ROIs for gynecological cancer treatment, following RTOG contouring recommendations.
  • Other new ROIs, such as CaudaEquina, Duodenum, Rectosigmoid and cardiac substructures are now available to further enhance treatment planning.

Commenting on the FDA clearance, Dharanipathy Rangaraj, CEO of MVision AI, said: “This FDA 510(k) clearance is a testament to our unwavering commitment to advancing the role of AI in radiotherapy. With the introduction of these new models, we are not only expanding the clinical capabilities of Contour+ but also setting a new standard for precision and efficiency in cancer treatment. Our focus remains on providing clinicians with intuitive, adaptable tools that enhance patient care without disrupting existing workflows.” 

Top Features & Benefits Contour+

  • Customizable Advanced Operations: Contour+ offers post-processing tools that allow users to modify AI-generated contours with minimal effort. This includes geometric transformations like dilation, erosion, hole filling, and operations using boolean logic (AND, OR, SUBTRACT) to merge or refine ROIs.
  • Clinical Flexibility: New ROIs and virtual structures, such as PRVs and optimization ROIs for H&N, breast, and pelvic treatments, can be created to ensure the solution meets a wide range of clinical needs.
  • Seamless Integration: The solution is compatible with existing workflows and can be customized for local clinical protocols, empowering radiotherapy departments to streamline processes and improve efficiency.
  • Eclipse API: Allows users to call Contour+ auto-segmentations directly from Eclipse. This also enables the rapid deployment of Contour+ without the need for additional hardware or IT resources.

About MVision AI

MVision AI is a leading provider of AI-powered solutions for radiation therapy treatment planning. Our mission is to empower Radiation Oncology professionals with cutting-edge technology to streamline workflows, enhance treatment quality, and facilitate more patient-focused care. With a commitment to innovation and excellence, MVision AI continues to advance cancer care through the power of AI.

Contact Information

Media Contact: Sakthy Edamaruku

Email: sakthy.edamaruku@mvision.ai

MVision AI Headquarters:

Paciuksenkatu 29, 00270,

Helsinki, Finland

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