First Light Field-Enabled Spine Surgery Navigation Platform, Proprio Paradigm™, Receives FDA Clearance

SEATTLE, April 25, 2023 — Proprio, a Seattle-based medical technology company, today announced its 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.

Proprio’s Paradigm platform is the first to use light field technology in spine surgery navigation 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.”

For more information, visit: www.propriovision.com.

Original press release on PR Newswire can be found here.
‍‍Becker’s Spine Review press release coverage here.
MassDevice press release coverage here.
BioSpace press release coverage here.
Orthopedic Design & Technology press release coverage here.
OrthoWorld press release coverage here.
Surgical Robotics Technology press coverage here.
mHealth Times press coverage here.
Medical Device Network press coverage here.
BioWorld press coverage here.
Ortho Spine News press coverage here.
HospiMedica press coverage here.
G‑MedTech News press coverage here.
OrthoFeed press coverage here.
FDA News press coverage here.

ABOUT PROPRIO

Proprio is a leading medical technology company creating the new way of seeing™ in surgery. Using advance­ments in light field computer vision and AI, the Proprio Paradigm system synthesizes views from multiple inputs for navigating anatomy and surgical envi­ron­ments in 3D. Proprio’s goal is to dramat­i­cally improve clinical and economic outcomes by unlocking both the ability to capture advanced data and the potential of that data to inform more predictive and prescrip­tive intel­li­gence in surgery. Proprio is backed by leading healthcare and technology investors, including DCVC (Data Collective), BOLD Capital Partners, Cota Capital, Intel, HTC, and Alan Frazier, founder of Frazier Healthcare Partners.