Twinsight Receives FDA 510(k) Clearance for SurgiTwin™

GRENOBLE, France – September 29, 2025 – Twinsight, a French medical technology company specializing in orthopedic surgical planning software, today announced it has received 510(k) clearance from the US Food and Drug Administration (FDA) for SurgiTwin™, its groundbreaking Software as a Medical Device (SaMD) platform designed to revolutionize preoperative planning for total knee replacement surgeries.

The FDA clearance, granted on August 28, 2025 (K250290), marks a significant milestone for the Grenoble-based startup and supports its innovative approach to AI-powered personalized preoperative planning. SurgiTwin™ 3D is the first AI-powered knee replacement surgery planning platform from a French company to receive FDA clearance for the US market.

Digital innovation at the center of a new era in orthopedic surgery

SurgiTwin™ 3D is a web-based platform that leverages advanced machine learning algorithms to assist orthopedic surgeons in preoperative planning for total knee replacement procedures. In just five minutes, the solution creates a personalized digital twin based on the patient’s CT scans, reducing operating room time and contributing to the quest for better patient outcomes.

“This FDA clearance is an achievement earned through years of research and development to create a solution that truly addresses the needs of orthopedic surgeons and their patients,” said Twinsight CEO Mathieu Rimaud. With SurgiTwin™ 3D, surgeons can access a 3D plan of the procedure, including clinical measurements, and compare different alignment strategies in just a few minutes. “SurgiTwin™ 3D transforms CT scans into actionable information, with unprecedented speed and accuracy, allowing surgeons to visualize and plan procedures more efficiently than ever before,” said Rimaud.

Advanced technology in service to surgeons and patients

SurgiTwin™ 3D offers several innovative features:

• AI-powered personalized digital twin generation: Advanced machine learning models automatically process CT scans to create precise 3D anatomical models





• Automatic landmark placement: Intelligent algorithms identify key anatomical landmarks with high accuracy, validated by expert clinical review





• Digital implant library: Extensive library of digital representations of routinely-used orthopedic implants





• Interactive planning environment: Intuitive 2D and 3D interfaces allowing surgeons to adjust and optimize surgical plans





• Detailed PDF reports with the images used, measurements, and surgical plan

The system’s machine learning model underwent rigorous testing and validation, achieving a mean Dice score greater than 0.95 and meeting all predefined clinical acceptance criteria for accuracy and performance.

Addressing the healthcare needs of an aging population

Total knee replacement surgery is one of the most common orthopedic procedures worldwide, with over 750,000 procedures performed annually in the United States alone. However, traditional planning methods often rely on approaches that may not account for variations in individual patients’ anatomies.

“The conventional one-size-fits-all approach to orthopedic surgery doesn’t factor in each patient’s unique anatomy,” explained Twinsight co-founder and Chief Medical Officer Antoine Perrier. “SurgiTwin™ 3D enables surgeons to create truly personalized surgical plans based on each patient’s specific anatomical characteristics, potentially leading to better surgical outcomes and improved patient satisfaction.”

Proven safety and efficacy

The FDA clearance was supported by extensive nonclinical performance testing, including:

• Comprehensive verification and validation of all software features





• Machine learning model development and testing with datasets from multiple clinical facilities





• Validation studies comparing automatic landmark placement to expert manual annotations





• External validation testing in real-world clinical environments





• Cybersecurity and software quality assessments

All testing demonstrated that SurgiTwin™ 3D meets or exceeds clinical acceptance criteria for accuracy, safety, and performance in its intended use.

Commercialization in the US and other international markets

With FDA clearance secured, Twinsight is now commercializing SurgiTwin™ 3D in the United States. The company is also pursuing regulatory approvals in additional international markets.

“FDA clearance means we can now bring our innovative technology to surgeons and patients across the United States,” said Twinsight CEO Mathieu Rimaud. “We’re excited to partner with healthcare providers who share our vision of personalized, precision orthopedic surgery.”

About Twinsight

Founded in 2020 and based in La Tronche (Grenoble), France, Twinsight is a medical technology company dedicated to developing innovative software solutions for orthopedic surgery planning. The company’s mission is to provide surgeons with a dynamic digital twin of each patient to personalize and improve surgical care. Today, the company’s groundbreaking SurgiTwin™ 3D is bringing unprecedented levels of precision to knee replacement surgery while saving precious operating room time. In the future, Twinsight intends to bring the power of personalized digital twins to joints other than the knee and introduce dynamic movement into its models to provide unprecedented 4D simulation. The company’s solutions will make operating blind a thing of the past by giving surgeons actionable data designed to improve patient outcomes.

Twinsight’s multidisciplinary team combines expertise in medical imaging, artificial intelligence, orthopedic surgery, and regulatory affairs to develop advanced technological solutions that address real-world clinical challenges.

SurgiTwin™ 3D is indicated for use by qualified healthcare professionals in preoperative planning for knee reconstruction procedures in adult patients over 22 years of age undergoing total knee replacement surgery. The system is designed to assist clinical decision-making and requires appropriate clinical judgment and experience for proper use.

Contact Information Mathieu Rimaud mathieu.rimaud@twinsight-medical.com +33668020561