ARTINESS secures FDA 510(k) clearance for ARTICOR Planner

ARTINESS has announced that its mixed-reality planning solution, ARTICOR Planner, has received FDA 510(k) clearance as software designed to support structural heart and vascular procedures. The clearance marks an important step as the company prepares to bring its technology into clinical use across the United States.

ARTICOR Planner enables advanced pre-operative planning based on patient-specific imaging. The software allows clinicians to analyze anatomy, plan device placement, and simulate delivery strategies using 3D reconstructions generated from medical imaging data. By combining these capabilities with mixed-reality visualization, the platform supports a more detailed understanding of complex anatomies ahead of procedures.

Founded in 2018 and headquartered in Milan, ARTINESS is a medtech company focused on developing software solutions that convert medical imaging data into patient-specific 3D models and immersive environments. Its broader ARTICOR platform integrates pre-operative planning with real-time intra-procedural navigation, enabling clinicians to interact with holographic representations of patient anatomy and support decision-making during minimally invasive cardiovascular interventions.

The company’s technology is designed to work with standard imaging modalities such as CT, MRI, and ultrasound, transforming them into interactive models that can be used for simulation, planning, and clinical collaboration. This approach reflects a growing focus on patient-specific planning in structural heart procedures, where precision and coordination are critical.

Filippo Piatti, CEO of ARTINESS, commented: “ARTICOR Planner lays the foundation for our broader vision: translating expert knowledge into software-driven, real-time guidance to make procedures safer, more standardized, and scalable across all hospitals.”

Piatti was part of the cohort that presented on stage at MedTech World North America 2025, where he joined the Diagnostics, Oncology, & Urology session, highlighting ARTINESS’s work in advancing digital tools for clinical decision-making.

The FDA clearance positions ARTINESS to expand its presence in the US market, where there is increasing demand for technologies that support minimally invasive and structurally complex procedures. As healthcare systems continue to adopt digital tools, solutions like ARTICOR Planner contribute to how procedures are planned and executed.

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