Proprio’s Paradigm Platform Cleared by FDA

Seattle-based medical technology company Proprio’s surgical navigation platform, Paradigm, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
 
Paradigm utilizes an advanced approach to replace traditional surgical navigation technologies that pull attention away from the patient and disrupt workflows in the process.

About Paradigm

Proprio’s Paradigm platform uses light field technology to create a real-time 3D view of anatomy and the surgical scene. The system uses an advanced sensor suite to capture high-definition multimodal intraoperative images and fuses that information with preoperative scans. Using this technology, surgeons can access helpful data - including intraoperative imaging and powerful visualization capabilities - all without any harmful radiation or impediment to their workflow. Proprio refers to this data fusion capability as Volumetric Intelligence.
 
Paradigm provides surgical teams with solutions that alleviate many clinical frustrations and challenges that burden surgery today. Potential benefits include:
 

• Reduction in Radiation: Removing the need for high-radiation intraoperative scans throughout the procedure can lead to a 10x reduction in radiation exposure.
• Accelerated Workflow: Removing the need for intraoperative scans can reduce workflow up to 30 minutes per procedure.
• Fast Registration: Previously, where intraoperative scans were required, the registration process can take between 15 to 30 minutes. Paradigm registration can be completed in seconds.
• Continuous Data Capture: Paradigm can collect a high volume of data with approximately 250GB of data captured per hour. Such valuable data drives Proprio’s product development process and informs advanced models for future applications.

 
“We are very enthusiastic about the potential for Paradigm to enable clinicians to revolutionize spine surgery,” said Gabriel Jones, CEO and co-founder of Proprio. “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 recognize, track and analyze complex anatomical structures. The potential of this technology in the hands of skilled clinicians has us all very optimistic about the future of surgical practice.”
 
“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,” said Dr. Samuel Browd, CMO and co-founder of Proprio. “As a clinician, the prospect of accessing a more complete set of data intraoperatively is very exciting.”