VivoSight AI Optical Coherence Tomography System
| Brand | CK |
|---|---|
| Origin | United Kingdom |
| Distributor Status | Authorized Distributor |
| Origin Category | Imported |
| Model | VivoSight AI (OCT) |
| Pricing | Upon Request |
Overview
The VivoSight AI Optical Coherence Tomography (OCT) System is a clinical-grade, non-invasive imaging platform engineered for high-resolution, cross-sectional visualization of skin microstructure in real time. Leveraging near-infrared (NIR) broadband light and interferometric detection principles, the system performs depth-resolved tomographic scanning with axial resolution down to approximately 7–10 µm and lateral resolution of ~15–20 µm—enabling visualization of epidermal layers, dermal-epidermal junction, papillary and reticular dermis, and superficial subcutaneous structures without tissue excision or contrast agents. Designed specifically for dermatology clinics and translational research settings, the VivoSight AI OCT supports objective, operator-independent assessment aligned with established diagnostic workflows for non-melanoma skin cancers (e.g., basal cell carcinoma, squamous cell carcinoma), inflammatory dermatoses, and treatment monitoring.
Key Features
- Multi-beam swept-source OCT architecture delivering enhanced signal-to-noise ratio (SNR) and improved penetration depth up to 2 mm in human skin;
- Real-time volumetric imaging with adjustable scan depth (0.5–2.0 mm) and customizable field-of-view (3 × 3 mm to 12 × 12 mm);
- Integrated AI-assisted image interpretation module trained on clinically annotated dermatopathological datasets to highlight structural anomalies consistent with BCC morphology;
- Motorized XYZ positioning stage with contact-free scanning mode and calibrated pressure-sensing interface to ensure reproducible probe-skin coupling;
- CE-marked medical device compliant with IEC 62304 (software lifecycle), IEC 60601-1 (electrical safety), and ISO 13485 (quality management systems);
- Compact, cart-mounted configuration with integrated touchscreen workstation and ergonomic handpiece for point-of-care deployment.
Sample Compatibility & Compliance
The VivoSight AI OCT is validated for use on intact human skin across Fitzpatrick skin types I–VI. It requires no topical coupling gels or ionizing radiation, making it suitable for serial longitudinal studies—including pre- and post-intervention monitoring in clinical trials. All imaging protocols adhere to Good Clinical Practice (GCP) guidelines and support audit-ready documentation for regulatory submissions. The system meets essential requirements under the EU Medical Device Regulation (MDR 2017/745) for Class IIa devices and is compatible with institutional review board (IRB)-approved study designs. Data output formats (DICOM 3.0, TIFF, and proprietary .vso files) facilitate integration into hospital PACS environments and comply with HIPAA-compliant storage architectures when deployed with approved network security configurations.
Software & Data Management
VivoSight AI software (v5.2+) provides FDA-cleared image acquisition, multiplanar reconstruction (MPR), layer segmentation, and quantitative morphometric analysis. Built-in tools enable automated epidermal thickness mapping, dermal collagen density estimation via speckle variance analysis, and depth-resolved vascular density profiling using Doppler-OCT-enhanced angiography algorithms. All user actions—including parameter adjustments, annotations, and measurement exports—are logged with timestamped, user-identified audit trails satisfying 21 CFR Part 11 requirements for electronic records and signatures. Raw data archives are stored in encrypted local repositories or configurable cloud-based storage (AWS HIPAA-eligible infrastructure), supporting version-controlled backups and DICOM-based interoperability with third-party dermatology informatics platforms.
Applications
- Non-invasive differential diagnosis of non-melanoma skin cancers (NMSC), including morphological characterization of tumor margins and peritumoral stromal reaction;
- Quantitative evaluation of epidermal hyperplasia/hypoplasia in psoriasis, atopic dermatitis, and ichthyosis;
- In vivo assessment of collagen remodeling during topical retinoid therapy, fractional laser treatments, or microneedling interventions;
- Depth-resolved microvascular mapping for assessing inflammatory activity in rosacea or evaluating angiogenic response in wound healing studies;
- Standardized endpoint measurement in cosmetic clinical trials—e.g., stratum corneum hydration gradients, transdermal delivery kinetics, and scaffold integration in bioengineered skin models.
FAQ
Is the VivoSight AI OCT system cleared for clinical diagnosis in the US?
Yes—the device holds FDA 510(k) clearance (K211792) for adjunctive use in the identification and characterization of non-melanoma skin lesions, as well as for dermatological research applications.
Does the system require routine calibration or service contracts?
The system incorporates self-diagnostic routines and factory-calibrated optical pathlength references; annual performance verification by CK-certified engineers is recommended and supported under extended service agreements.
Can VivoSight AI OCT images be exported for third-party AI model training?
Yes—de-identified volumetric datasets can be exported in NIfTI or DICOM format, subject to institutional data governance policies and adherence to GDPR or HIPAA-compliant transfer protocols.
What training is provided upon installation?
CK delivers on-site clinical workflow training for operators and biomedical engineers, including image acquisition standardization, quality assurance procedures, and software-based quantitative analysis modules.
