Provect AI Secures FDA 510(k) Clearance, Raises $7M

Palo Alto, Calif. — July 16, 2026 — Provect AI, a medical imaging company that delivers intraoperative 3D imaging without a CT scanner, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its software platform. The software enables surgeons to generate advanced intraoperative 3D images from standard C-arm X-ray systems already found in operating rooms—without a CT scanner, new imaging hardware, or changes to existing surgical workflow.

Demand for advanced intraoperative imaging is accelerating as spine and orthopedic procedures shift into ambulatory surgery centers (ASCs), where CT access has historically been unavailable. In 2026, CMS added key spine CPT codes to the ASC list, accelerating a migration that is shifting surgical volume to precisely the settings where advanced imaging isn't available. By building on existing C-arm infrastructure, Provect AI helps providers expand access to 3D imaging while preserving familiar workflows and avoiding significant capital investment.

“Surgeons are operating in 2D when they need 3D,” said Dorian Averbuch, Founder and CEO of Provect AI. “We founded Provect on a simple belief: advanced intraoperative 3D imaging shouldn't require an additional imaging system. As spine surgery rapidly moves into CT-less ambulatory surgery centers while hospitals continue to seek more efficient imaging solutions, FDA clearance marks an important milestone toward making advanced 3D imaging accessible in every operating room using equipment providers already own.”

How Provect AI Works

Provect AI combines a physics-aware approach with the science of medical imaging to reconstruct intraoperative 3D images from conventional C-arm X-rays. Rather than relying on pattern matching alone, Provect AI incorporates the physics of how an X-ray beam passes through human tissue, ensuring reconstructions are grounded in real, patient-specific data.

Designed as a vendor-agnostic platform, Provect AI transforms standard C-arm X-rays into volumetric 3D images, helping spine and orthopedic surgeons better assess anatomy during image-guided interventions. Because the platform extends equipment providers already own, it enables integration with third-party navigation or imaging software they already trust—with no additional imaging system to buy and no workflow to relearn.

• Vendor-agnostic: Works with the standard C-arm systems already installed in operating rooms at hospitals and ASCs.

• Intraoperative 3D: Provect AI software platform reconstructs volumetric 3D images from standard 2D C-arm X-rays, providing surgeons with the anatomical clarity they need during image-guided procedures.

• Open Ecosystem: Exports reconstructed images in standard DICOM format, making them compatible with hospital PACS systems and third-party navigation or imaging software.

• Workflow-preserving: Requires no CT scanner, no new imaging hardware, and no changes to existing surgical workflow.

“Reliable intraoperative 3D imaging is becoming increasingly important as more procedures are performed in ambulatory surgery centers,” said Philip K. Louie, MD, fellowship-trained, board-certified orthopedic spine surgeon and a Clinical Advisor to Provect AI. “The ability to generate advanced 3D visualization using standard C-arm systems has the potential to improve surgical decision-making while integrating naturally into existing operating room workflows.”

Accelerating Commercialization

Alongside FDA clearance, Provect AI has raised $7 million to support commercial expansion, customer deployments, continued product development, and broader clinical adoption. Its recent financing round was led by Arteria Capital and ValueStream Ventures, with participation from Newfund Capital and Sand Hill Angels.

“We are excited to support Provect as they enter commercialization,” said Russell Glass, Managing Director at Arteria Capital. “Provect’s software-first approach dramatically expands access to intraoperative 3D imaging by building on equipment providers already own. We believe the company is well positioned to help shape the future of surgical imaging and is a great example of how AI can be used to transform healthcare delivery.”

Provect AI is also a member of StartX, a startup accelerator for Stanford-affiliated entrepreneurs and the NVIDIA Inception program. The company’s technology has been evaluated through 25 validation studies and developed in collaboration with leading surgeons, healthcare systems, and academic medical centers.

Following FDA clearance, the company will begin commercial deployments with leading spine surgeons, ambulatory surgery centers, and hospital systems while continuing to expand clinical collaborations and generate real-world evidence across spine, orthopedic, and other image-guided surgical procedures.

About Provect AI

Provect AI is a medical imaging company that uses a physics-aware approach to generate volumetric 3D images from standard C-arm X-rays. Delivered as a vendor-agnostic platform, Provect makes advanced 3D imaging accessible at the point of care, helping surgeons operate with greater confidence while bringing hospital-grade capability to ambulatory surgical centers. Founded by a proven MedTech team with multiple FDA-cleared products and successful exits, Provect is developed in collaboration with healthcare providers from leading Northern California health systems and academic medical centers, along with partnerships with StartX, a startup accelerator for Stanford-affiliated entrepreneurs, NVIDIA Inception Program, and AWS for Startups. Backed by 30+ KOL endorsements and 25 validation studies, the company's first applications are in spine surgery, interventional pain, and orthopedics. For more information, visit www.provectai.com.

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Provect AI 3D-Anywhere™ software has received U.S. FDA 510(k) clearance for its indicated use. Availability may vary by country. Refer to the Instructions for Use for complete indications, limitations, warnings, and precautions. Future features, product enhancements, and regulatory plans described on this website are subject to change and may require additional regulatory review or clearance before commercial availability.

The Provect AI software platform is indicated for generating three-dimensional image reconstructions from compatible fluoroscopic C-arm X-ray systems to assist physicians during spine and orthopedic procedures. Refer to the Instructions for Use for complete indications, contraindications, warnings, and precautions.

The information on this website is intended for healthcare professionals and informational purposes only.

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