Provect AI wins FDA 510(k) clearance for 3D intraoperative imaging from standard C-arm x-rays, raises $7M

Intraoperative 3D imaging has traditionally meant either an O-arm-class CT-capable system or an image-guided-navigation workflow that requires preop CT registration. Both are capital-intensive; both concentrate spine and orthopedic image-guided procedural volume at academic and large regional hospitals that can amortize the equipment.

Provect is targeting the much larger installed base of ordinary C-arms — most operating rooms already have one — and doing the volumetric reconstruction in software. If the clinical performance holds up outside the 510(k) validation set, this is a classic “capex to opex” swap for orthopedic and spine service lines. It also shortens the distance between community hospitals and image-guided procedural care in exactly the kind of “shift of care to lower-cost sites” thesis that CMS and commercial payers have been leaning into.

Two things worth watching as deployments start. First, the DICOM export and third-party navigation-system compatibility — a reconstruction that can’t talk to StealthStation, StealthNav, or the newer robotic-navigation platforms is much less useful than one that can. Second, the workflow-tax: how much extra table-time the reconstruction adds, and whether the OR-throughput math still favors it once you count that.

The $7M round — Arteria Capital and ValueStream Ventures leading, with Newfund and Sand Hill Angels — is small by 2026 imaging-AI standards but arguably right-sized for a software-only 510(k) product with clear commercial pull.

Related coverage: medical imaging AI topic, FDA & devices topic.