Proprio has received its second 510(k) clearance from the FDA for its surgical guidance platform, Paradigm. This new clearance allows the inclusion of intraoperative measurements, making Paradigm the first technology of its kind to offer 3D, dynamic, and segmental visualisation of anatomy in real time during surgery.
The platform enables surgeons to monitor and assess surgical outcomes such as spinal alignment while the operation is ongoing, significantly reducing the need for intraoperative radiation. This development not only supports better decision-making during procedures but also minimises exposure to harmful imaging techniques for surgical teams.
Previously, intraoperative measurements required surgeons to stop the procedure, remove themselves from the sterile field, and perform additional imaging such as X-rays or CT scans. This often resulted in delays while patients remained under anaesthesia, increasing risks and blood loss. As a result, many surgeons had to rely on preoperative plans and wait until after surgery to assess success, which sometimes led to the need for revision operations.
Paradigm now provides real-time data during procedures, allowing surgeons to compare progress against their surgical plans continuously. The system accurately measures anatomical changes during surgery, helping to ensure precise outcomes and reducing the likelihood of follow-up surgeries. By eliminating the need for intraoperative radiation, the platform also improves working conditions for surgical teams and creates a safer operating environment.
The technology assists in improving surgical training as well, offering a clear and interactive view of procedures. It supports teaching for medical students, residents, and fellows by providing a data-driven learning experience.
