Today, we’re proud to share a major milestone: the FDA has granted clearance for a Predetermined Change Control Plan (PCCP) for our patented, AI-driven segmentation software, Axial3D INSIGHT™, making Axial3D the first image segmentation company with this clearance and market fundamental patents covering AI/ML-enabled segmentation. This milestone is a strong endorsement of our expertise, processes, and ability to deliver safe, effective, and continuously evolving software as a medical device, and it reflects our ongoing commitment to helping medical device companies dramatically reduce time to patient, scale across their offerings, and deliver patient-specific solutions as standard (rather than the exception).
What a PCCP Means for Our Partners
Through a Predetermined Change Control Plan, Axial3D can continuously update and enhance our machine learning models, verifying each change through a robust framework and releasing improvements efficiently without repeated FDA submissions. Operating under a PCCP demonstrates that Axial3D meets the highest bar for safety, effectiveness, and continuous improvement. Partners can trust that every patient specific model and dataset is built on a foundation of regulatory rigor and technical excellence.
For medical device companies, this translates to:
- Faster delivery of patient-specific solutions: tune algorithms to specific clinical applications more quickly through PCCP-verified updates, reducing time from development to go-live.
- Enterprise scalability: AI-powered segmentation and planning that evolves alongside your device portfolio, enabling consistent, repeatable workflows at scale
- Regulatory confidence: every update is backed by our FDA 510K clearances
Continuous Innovation for Patient-Specific Care
Axial3D INSIGHT™ is recognized worldwide for delivering the highest-quality, patient-specific models with exceptional accuracy and the least time. We already empower companies around the world with personalized surgical planning solutions at scale, and now, with the PCCP, we can provide new and enhanced solutions faster and smarter than ever, building on our market fundamental patent foundation to enhance algorithm capabilities, deliver richer anatomical segmentation, and scale to enable patient-specific offerings as standard..
The machine learning algorithms that power our platform can be rapidly adapted for medical device workflows across diverse anatomies and clinical specialties, giving partners the flexibility to deploy solutions quickly and confidently.
The result isn’t just continually improved software, it’s faster access for partners to harness advanced segmentation, integrate into workflows, and develop next-generation device selection and placement, surgical planning, implant and guide design, and robotic planning solutions.
“FDA acceptance of our PCCP for Axial3D INSIGHT™ is a landmark moment for our team and our partners,” said Roger Johnston, Axial3D CEO. “I’m incredibly proud of our team, their expertise, dedication, and innovative spirit made this possible. This milestone validates the rigor of our approach and gives us the flexibility to evolve our AI-driven segmentation faster than ever. It means we can deliver even richer, more detailed models, accelerate innovation and adoption for medical device companies, and ultimately help surgeons and patients benefit from truly personalized solutions at scale.”
Looking Ahead
This milestone isn’t just about what we’ve achieved; it’s about what it enables next. With our market fundamental patented, AI/ML based segmentation platforms and the flexibility of a PCCP, Axial3D can accelerate patient-specific solutions, increase their precision, and support medtech companies in scaling personalized care globally with sustainable competitive advantage.
At Axial3D, we believe the future of healthcare will be underpinned by AI, automation, and 3D understanding. Holding an FDA cleared PCCP ensures we can continue setting new standards, helping partners innovate faster and ultimately improve outcomes for millions of patients worldwide.
