MediView XR

The grade describes the mechanism, not the quality of the product, and this is a case where the distinction matters. What XR90 does is spatial registration and rendering: aligning a prior CT volume to a live ultrasound stream and to a tracked instrument, then displaying the result stereoscopically in the correct anatomical position. That is a hard computer vision and computer graphics problem, and solving it well is the achievement, but it is not primarily a machine learning one. Segmentation of the CT into the 3D anatomical model is the step most likely to use learned models today, and it is upstream of the differentiator rather than being it. No machine learning component, model or method is named anywhere in public materials, while the company's funding communications describe the platform in terms of augmented reality AND AI. A buyer evaluating this should understand they are purchasing a cleared augmented reality navigation device, and should ask specifically which components are learned and how they were validated.

The constraint here is unusually firm because a regulator wrote it. XR90 is cleared for ADJUNCTIVE use, meaning it supplements rather than replaces standard imaging and technique, and the clinician retains the instrument and the decision throughout. The system displays; it does not act, advise or move anything. That is a stronger structural position than most of this index can claim, and it is enforced by the label rather than by vendor policy. Held at B rather than A because the safety question in navigation is not autonomy but ACCURACY, and no registration error tolerance, drift behaviour or failure mode is published. A navigation system that is confidently wrong by a centimetre is more dangerous than one that declines to display, and nothing states what the system does when registration degrades, when the patient moves, or when ultrasound and CT disagree.

The capability set is described clearly and the method behind it is not. Public materials name the components a user sees, namely CT derived 3D holographic anatomy, live ultrasound projected in anatomical position, and a holographic light ray tracking the instrument path, but no registration method, tracking approach, accuracy specification or model description is given. For a navigation device the decisive technical disclosure is registration accuracy under stated conditions, and it does not appear in any public material located.

Substantially better evidenced than most of this list, and short of the top grade only on publication. The regulatory evidence is real: a 510(k) clearance carries a reviewed submission behind it, and the indication is specific rather than vague. A trial of the system's navigation accuracy was reported in March 2024 and described as demonstrating precision sufficient for clinical use. First clinical use is documented with a named operator and a named institution, Dr Bradley B. Pua, Chief of Interventional Radiology at NewYork-Presbyterian / Weill Cornell Medical Center, performing a mediastinal lymph node biopsy in November 2023. The origin is Cleveland Clinic intellectual property with an early clinical investigation team there. What is missing: no peer reviewed publication was located, the accuracy trial's numbers, cohort and methodology are not public, and there is no comparative outcome evidence showing that augmented reality navigation changes procedural success, complication rates or radiation exposure against conventional guidance, which is the claim a health system would need to justify the purchase.

No statement on protected health information handling, retention, or whether procedural data leaves the institution was located. The product ingests a patient's full CT volume and renders it in the procedure room, and augmented reality headsets are capable of capturing the surrounding environment including staff and patient, so there is a real question here about what the device records versus merely displays. Nothing public addresses it in either direction.

No HIPAA compliance statement or business associate agreement terms were located. As a cleared device sold into United States hospitals, MediView will be operating under institutional agreements, but nothing publicly verifiable was found.

No SOC 2, ISO 27001, IEC 62304 or equivalent attestation, and no trust centre or security documentation, was located publicly. Note that a cleared device carries quality system obligations under FDA regulation that a pure software vendor does not, so the underlying engineering controls are likely more formalised than this absence suggests, but nothing verifiable is published.

The strongest regulatory position on this sourcing list and one of the cleaner ones in the index. XR90 holds FDA 510(k) clearance granted in July 2023 with a specific and legible indication: adjunctive use in minimally invasive ultrasound and CT guided needle based procedures for soft tissue and bone. The company states it was the first 510(k) clearance for an augmented reality device combining live imaging with 3D extended reality visualisation across both pre operative and intra operative indications, which if accurate places it in the category creating class this index recognises in Viz.ai's first computer aided triage De Novo and Cognivue's De Novo. Two points of discipline. The clearance covers XR90 as an adjunctive visualisation and navigation aid, so it authorises the display, not any autonomous determination. And a buyer should read the indication against their intended use, since needle based soft tissue and bone procedures is narrower than surgical navigation generally.

No fairness, subgroup or performance variation disclosure was located, and there is a concrete version of that question specific to this device rather than a generic one. Registration accuracy between a prior CT and live ultrasound depends on tissue characteristics, body habitus, respiratory motion and acoustic window quality, all of which vary systematically across patient populations. A navigation system that registers less accurately in larger patients or in those with poorer acoustic windows would be quietly less safe for those patients, and no per population accuracy data is published. Separately, to record neutrally: Mayo Clinic and Cleveland Clinic are investors in the company, Cleveland Clinic is also the origin of the underlying intellectual property and hosted the early clinical investigation work. That is common in device commercialisation and is not an accusation, but it means the institutions closest to validating the technology also hold an interest in it, the same caveat this index records for CodaMetrix.

Interoperability here means imaging systems rather than the electronic health record, and on that side the product is necessarily connected: it consumes prior CT volumes and ingests a live ultrasound feed intraoperatively. Neither the imaging standards supported, the ultrasound systems validated, nor the PACS or CT vendors integrated are named publicly, and no EHR or procedural documentation path is described. The GE HealthCare investment raises an obvious question a buyer should ask directly, namely whether integration is being optimised for or restricted to particular imaging estates.

On premise in the procedure room by necessity, since the system must register to live ultrasound with no tolerance for latency. Display is delivered through the Microsoft HoloLens 2 headset, and that dependency is the most important deployment question a buyer should raise. The clinical viability of a cleared device rests on hardware whose roadmap, availability and support lifecycle belong to a third party and sit outside MediView's control, and a headset that becomes unavailable or unsupported is a supplier continuity problem for the platform rather than a peripheral one. This index treats supplier continuity as a legitimate procurement criterion on the Behold.ai precedent. Establish the hardware continuity plan and whether XR90 is being ported to alternative headsets, and note that a change of display hardware may itself carry regulatory consequences. No hosting, region or data residency detail is published.

No price, tier or commercial model is published. For a device platform the relevant questions are more numerous than for software and none is answered publicly: whether the system is capital purchase or subscription, whether headsets are included or separately procured, whether per procedure consumables or tracking hardware apply, and what service and calibration coverage costs. Reimbursement is the other half a buyer must model, since augmented reality navigation adjunctive to a needle procedure has no obvious separate payment pathway, and no reimbursement position is published.

Narrow, well defined and honestly stated, which is worth more than a broad claim. The cleared scope is minimally invasive ultrasound and CT guided needle based procedures for soft tissue and bone, with biopsies and tumour ablations named as the exemplar uses, and the primary buyer is interventional radiology rather than the operating theatre. Named clinical settings are NewYork-Presbyterian / Weill Cornell and Cleveland Clinic. The company describes broader ambitions across image guided intervention and has separately explored applications such as assessing resectability in ovarian cancer, but those sit outside the current clearance. A buyer in orthopaedic, neurosurgical or laparoscopic navigation should treat this as out of scope today.