Daily Newsletter

25 January 2024

Daily Newsletter

25 January 2024

Enhatch gains FDA clearance for total knee arthroplasty system

The system utilises artificial intelligence (AI) to transform patient X-rays or computed tomography (CT) images into detailed 3D anatomic models.

Surya Akella January 25 2024

Enhatch has secured US Food and Drug Administration (FDA) 510(k) clearance for its patient-specific AI-driven instrumentation system for total knee arthroplasty.

The system utilises AI to transform patient X-rays or CT images into detailed 3D anatomic models.

These models are integral for the development of comprehensive treatment plans and the creation of customised surgical guides, streamlining the surgical process.

Enhatch president and chief technology officer Michael Phipps said: “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 modelling of individual anatomies and planning treatments, we are setting new benchmarks within the industry.”

The new technology is said to be a leap forward in preoperative planning by using X-ray based systems, which offer the advantage of reduced radiation exposure when compared with traditional full-knee CT scans.

The reduction in radiation is not only beneficial for patient safety but also enhances the precision of anatomic models.

X-rays are more readily available and commonly reimbursed within the US healthcare system, making this AI-driven method a more operationally efficient and cost-effective option for total knee arthroplasty.

The approach prioritises patient safety, accuracy and affordability in surgical preparation.

Enhatch senior project R&D manager Scott Mozeleski said: “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.”

Enhatch has partnered with 3D Systems for manufacturing, packing and delivering patient-specific instrumentation to healthcare providers.

Uncover your next opportunity with expert reports

Steer your business strategy with key data and insights from our latest market research reports and company profiles. Not ready to buy? Start small by downloading a sample report first.

Newsletters by sectors

close

Sign up to the newsletter: In Brief

Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Thank you for subscribing

View all newsletters from across the GlobalData Media network.

close