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510(k) clearance for TKA PSI system with Intelligent Surgery Knee

Enhatch Announces FDA Clearance for a TKA Patient-Specific Instrumentation System with AI-Assisted Segmentation and Treatment Planning.

HASBROUCK HEIGHTS, New Jersey, January 24, 2024 - Enhatch Inc. is excited to announce the U.S. Food and Drug Administration (FDA) 510(k) clearance of a patient specific instrumentation system for Total Knee Arthroplasty. This state-of-the-art system is redefining total knee arthroplasty with its AI-driven approach, encompassing both anatomic model generation and treatment planning. The system’s AI algorithms can convert either patient X-rays or CT images into detailed 3D anatomic models to be utilized in comprehensive treatment plans, culminating in the creation of highly personalized surgical guides in a more efficient manner.

"The recent FDA clearance represents a major company milestone in advancing surgical precision and elevating the standard of patient care. Our Intelligent Surgery Knee software plays a pivotal role in streamlining preoperative planning and crafting patient-specific guides with enhanced efficiency. Leveraging cutting-edge AI technology for accurate modeling of individual anatomies and planning treatments, we are setting new benchmarks within the industry," commented Michael Phipps, President and CTO of Enhatch, Inc.

The use of X-ray based systems for preoperative planning marks a significant advancement in surgical preparation, offering reduced radiation exposure compared to traditional full knee CT scans. This approach not only lessens the patient's exposure to radiation but also serves as a cornerstone in generating accurate anatomic models, allowing for more precise and tailored surgical strategies. X-rays are more accessible and widely reimbursed in the U.S. healthcare system, making this method an operationally efficient and cost-effective solution. By integrating this technology, both patients and healthcare providers benefit from a streamlined process that emphasizes safety, accuracy, and affordability.

“We are excited to launch this new end-to-end patient-specific system designed to seamlessly integrate into surgical practices. Surgeons can effortlessly submit X-ray or CT images, along with treatment details and preferences. Our advanced AI algorithms then go to work to generate precise anatomic models, information for preoperative plans, and surgical guide designs. Planners assess the generated outputs and actively collaborate with surgeons to ensure thorough review and approval of the preoperative plans. By harnessing the power of AI-driven technologies, we aim to optimize surgical workflows for patient-specific surgeries. This commitment aligns with our objective in providing a heightened level of professionalism to patient care”, said Scott Mozeleski, Senior Project R&D Manager, Enhatch, Inc. 

The Patient Specific Instrumentation is manufactured, packaged, and shipped by 3D Systems, Enhatch’s manufacturing partner, to efficiently provide the instrument kits to the point-of-care. Surgeons interested in elevating their surgical practice with AI technology can contact Enhatch for more information.

Forward-Looking Statements

This release contains forward-looking statements under the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties and should not be relied upon as guarantees of future performance.

About Enhatch Inc.

Enhatch Inc. is revolutionizing surgical planning, making it faster, safer, and smarter. We specialize in delivering personalized implants and instruments through our advanced software solutions. Our platform streamlines preoperative planning and collaboration, empowering medical professionals with cloud-based, AI-powered tools to plan and scale personalized medical solutions. For more information, visit www.enhatch.com

Read the PR Newswire article here.