VivoSight Dx has received FDA 510(k) Clearance K153283
The system is indicated for use in the two-dimensional, cross-sectional, real-time imaging of external tissues of the human body.
This indicated use allows imaging of tissue microstructure, including skin, to aid trained and competent clinicians in their assessment of a patient’s clinical conditions.
Benefits in Clinical Practice
Quickly see below the surface
- Provides High-Resolution, Cross-Sectional Images of Sub-Surface Skin Tissue
- Visualizes Blood Vessels in the Upper Dermis
- Aids in Assessing your Patient’s Condition
Clinical Practice Imaging
Example of VivoSight OCT image of a skin lesion
VivoSight Dx display showing Vertical, Enface, Camera and 3D Surface Views of skin lesion
VivoSight Dx display showing Dynamic OCT Visualization of Nasal Skin Vasculature
VivoSight Dx OCT Image of skin lesion,
Image Size: 6mm x 2mm
VivoSight Dx OCT Image of skin lesion
Image Size: 6mm x 2mm
VivoSight Dx OCT Image of skin lesion
Image Size: 6mm x 2mm
References:
1. Schuh S., Welzel J. (2020) OCT-Guided Laser Treatment and Surgery. In: Bard R. (eds) Image Guided Dermatologic Treatments. Springer, Cham
2. Ulrich M, Braunmuehl T, Kurzen H, Dirschka T, Kellner C, Sattler EC, Berking C, Welzel J, Reinhold U. The sensitivity and specificity of optical coherence tomography for the assisted diagnosis of nonpigmented basal cell carcinoma: an observational study. Br J Dermatol. 2015;173(2):428–35.
3. Markowitz O, Schwartz M, Feldman E, Bienenfeld A, Bieber AK, Ellis J, Alapati U, Lebwohl MG, Siegel DM. Evaluation of optical coherence tomography as a means of identifying earlier stage basal cell carcinomas while reducing the use of diagnostic biopsy. J Clin Aesthet Dermatol. 2015;8(10):14–20.
4. Cheng HM, Lo S, Scolyer R, Meekings A, Carlos G, Guitera P. Accuracy of optical coherence tomography for the diagnosis of superficial basal cell carcinoma–a prospective, consecutive, cohort study of 168 cases. British Journal of Dermatology. 2016 May 1.
5. Sinx KA, Tonk EH, Kelleners-Smeets NW, Winnepenninckx VJ, Nelemans PJ, Mosterd K. Optical Coherence Tomography for non-invasive diagnosis and subtyping of Basal Cell Carcinoma, a prospective cohort study. Journal of Investigative Dermatology. 2020 Mar 6.
6. Feng H, Christman MP, Holmes J, Geronemus RG. Utilization of optical coherence tomography as a noninvasive, bedside imaging technique to identify residual nodular basal cell carcinoma at a well-healed and clinically unidentifiable biopsy site. J Am Acad Dermatol. 2019 Jul;81(1).
7. Themstrup L, De Carvalho N, Nielsen SM, Olsen J, Ciardo S, Schuh S, Nørnberg BM, Welzel J, Ulrich M, Pellacani G, Jemec GBE. In vivo differentiation of common basal cell carcinoma subtypes by microvascular and structural imaging using dynamic optical coherence tomography. Exp Dermatol. 2018;27(2):156–65.
8. Ahluwalia J, Avram MM, Ortiz AE. Outcomes of Long-Pulsed 1064 nm Nd:YAG Laser Treatment of Basal Cell Carcinoma: A Retrospective Review. Lasers Surg Med. 2019 Jan;51(1):34-39.
9. Ahluwalia J, Avram MM, Ortiz AE. The Evolving Story of Laser Therapeutics for Basal Cell Carcinoma. Dermatol Surg. 2020 Feb 11.
10. Markowitz O, Psomadakis CE. Patient-driven management using same-day noninvasive diagnosis and complete laser treatment of basal cell carcinomas: a pilot study. Cutis. 2019 Dec;104(6):345-348;350;351;E1;E2.
11. Markowitz O, Tongdee E, Levine A. Optimal cosmetic outcomes for basal cell carcinoma: a retrospective study of nonablative laser management. Cutis. 2019 May;103(5):292-297;E1;E2;E3.
12. Stephens R, Holmes J, Eadie E. Lesion compression during light activation may improve efficacy of Photodynamic Treatment (PDT) of Basal Cell Carcinoma (BCC): Preliminary results and rationale. J Eur Acad Dermatol Venereol. 2020 Apr 20. doi: 10.1111/jdv.16503.
13. L. Schmitz L, Bierhoff E, Dirschka T. Optical Coherence Tomography Imaging of Erythroplasia of Queyrat and Treatment with Imiquimod 5% Cream: A Case Report. Dermatology DOI: 10.1159/000354652.
Applications
Explore the research and clinical applications for VivoSight
Advance Your Research and Development Programs
VivoSight Dx in combination with VivoTools image analysis software visualizes and quantifies treatment effects.
See the Whole Picture to Improve Outcomes
VivoSight Dx produces high resolution imaging of skin sub-structures and vascular networks to aid in patient care
