Medical technology company Proprio has received 510(k) clearance from the US Food and Drug Administration (FDA) for its surgical navigation platform, Paradigm.
Paradigm is claimed to be the first light field technology-enabled navigation platform for use in spine surgery.
The platform is designed to replace traditional surgical navigation technologies to enable enhanced focus on patients and better workflows.
The navigation system provides a real-time 3D view of anatomy and the surgical process. Equipped with an advanced sensor suite, it captures high-definition multimodal intraoperative images and then fuses the data with preoperative scans.
Proprio CEO and co-founder Gabriel Jones said: “We are very enthusiastic about the potential for Paradigm to enable clinicians to revolutionise spine surgery.
“We’re reimagining how surgery is done rather than reconfiguring legacy tools. This uniquely positions our system to effectively capture the valuable data needed to feed advanced computer vision and deep-learning models to recognise, track and analyse complex anatomical structures.
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“The potential of this technology in the hands of skilled clinicians has us all very optimistic about the future of surgical practice.”
The technology enables surgeons access to data covering intraoperative imaging and visualisation without exposure to harmful radiation as it eliminates the need for high-radiation intraoperative scans.
Avoiding intraoperative scans can lead to reduced workflow by up to 30 minutes per procedure.
Paradigm also enables quick registration and continuous capture of 250GB of data per hour.
Proprio chief medical officer and co-founder Dr Samuel Browd said: “Historically, the focus has been on guiding procedures using preoperative data while using high-radiation intraoperative scans to fill in the gaps.
“Traditional surgical navigation systems collect very little intraoperative data. As a clinician, the prospect of accessing a more complete set of data intraoperatively is very exciting.”