VIO Skin

by Enspectra Health  · Based in United States → — The Next Revolution in Imaging is Here: Digital Dermatology with Cross-Modal Technology.
Dermatology Pathology

Contact for pricing
Regulatory Status Disclosed

Overview

Enspectra Health is leading the digital era in dermatology with its first-in-class cross-modal technology. This innovative handheld technology instantly generates high-resolution digital images of live cells without the need for an incision, providing valuable AI-powered insights for all aspects of skin health.

The VIO System is a revolutionary skin imaging system that combines novel multiphoton laser scanning with reflectance confocal microscopy to deliver actionable cellular information noninvasively in real time. Enspectra Health’s mission is to transform how skin is evaluated and managed by leveraging groundbreaking imaging and machine learning technology, arming dermatologists with the data they need, at the point of care in real time, to provide advanced patient-centric care.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered insights
  • First-in-class cross-modal technology
  • Handheld and portable device
  • Instantly generates high-resolution digital images of live cells
  • Non-invasive (virtual biopsy, no incision)
  • Combines multiphoton laser scanning with reflectance confocal microscopy
  • Delivers actionable cellular information in real-time
  • Digitizes pathology directly from a patient's skin
  • Provides cross-sectional, histology-like images of skin
  • Aids in clinical decision-making

Use Cases

  • Evaluating skin lesions non-invasively
  • Assessing lesions suspicious of basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) in high-risk populations
  • Tracking changes in skin tissue over time (e.g., aging skin, sun damage, treatment efficacy)
  • Minimizing unnecessary biopsies and facilitating earlier disease diagnosis
  • Evaluating general skin health and photoaging
  • Assessing efficacy of topical drugs in pigmentation disorders, rashes, eczema, and similar conditions

What Physicians Need to Know

Key Capabilities
AI-powered platform for real-time, non-invasive assessment of skin lesions, specifically for basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) in high-risk populations. It combines reflectance confocal and multiphoton microscopy to provide cellular-resolution, cross-sectional imaging of skin in seconds, effectively performing a 'virtual biopsy'. The VIO.ai NMSC software function offers computer-aided diagnosis and triage (CADx/CADt) for lesion classification.
Clinical Utility
Aids clinicians in the early identification and classification of non-melanoma skin cancer (NMSC), supporting clinical decision-making and potentially minimizing unnecessary biopsies. It provides immediate, actionable cellular information at the point of care, which can inform treatment strategies for various dermatological conditions. Clinical studies showed physicians identifying skin features on VIO images with >90% average accuracy.
Integration Options
The VIO Skin Platform integrates its FDA-cleared VIO technology with the VIO.ai NMSC software function. The device itself is portable and handheld, suggesting ease of integration into clinical workflows.
Compliance Status
The VIO System has received US FDA 510(k) clearance. The AI-powered VIO Skin Platform, which includes the VIO.ai NMSC software, has been granted FDA Breakthrough Device Designation, aiming to expedite its development and approval process due to its potential to improve diagnosis of serious conditions.
User Experience
Described as an 'easily portable and handheld' device that offers 'valuable clinical insights for physicians in a matter of seconds' by digitizing pathology directly from the patient's skin. It is non-invasive, providing a 'mini x-ray of your skin' experience.
Implementation Complexity
The device's portable and handheld nature suggests a relatively low physical implementation complexity. Initial availability is to 'select clinical partners,' indicating a controlled rollout.
Evidence Base
The VIO System's safety and effectiveness were demonstrated in the prospective, multicenter VISTA US Pivotal Study. Physicians achieved over 90% average accuracy in identifying skin features using VIO images in clinical studies, and the FDA was reportedly impressed with the strong clinical data.
Physician Tip

Consider VIO Skin for high-risk patients requiring frequent monitoring or when a non-invasive, real-time assessment of suspicious lesions (BCC/SCC) is beneficial to reduce unnecessary biopsies. Its ability to provide cellular-level insights at the point of care can significantly streamline diagnostic workflows and inform immediate clinical decisions. The portability makes it adaptable to various clinical settings. Keep an eye on its expanded indications and AI/ML algorithm advancements for broader dermatological applications.

The primary integration highlighted is the combination of the VIO imaging technology with its proprietary VIO.ai NMSC software for computer-aided diagnosis. While the device is portable and designed for point-of-care use, specific details regarding integration with existing electronic health record (EHR) systems or other hospital information systems were not explicitly mentioned in the available information.

Details

Category Dermatology AI
Pricing Contact for pricing
DeploymentOn-premise (device-based)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The VIO System received FDA 510(k) clearance in January 2024, marking it as the first multiphoton imaging modality cleared by the FDA. The VIO Skin Platform also holds FDA Breakthrough Device Designation for evaluating lesions suspicious of basal cell and squamous cell carcinoma in high-risk populations.

Integrations
EHR Not specified
Specialties Dermatology, Pathology

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Press & Coverage

Enspectra Health (Press Release)
Enspectra Health Announces Publication of VIO Skin Imaging System Clinical Study in Lasers in Surgery and Medicine
Enspectra Health announced the publication of a clinical study on its VIO Skin Imaging System in the journal Lasers in Surgery and Medicine, highlighting the system's ability to provide real-time, non-invasive cellular-resolution imaging of skin.
2024-05
Enspectra Health (Press Release)
Enspectra Health's VIO Skin Imaging System Featured in Dermatology Times
This press release highlights the VIO Skin Imaging System's feature in Dermatology Times, discussing its potential to transform dermatological diagnostics through advanced imaging capabilities.
2024-03
Lasers in Surgery and Medicine (Peer-Reviewed Journal)
Real-time, Non-invasive Cellular-resolution Imaging of Skin with a Handheld Reflectance Confocal and Multiphoton Microscopy Device
This peer-reviewed article details a clinical study on the VIO Skin Imaging System, demonstrating its efficacy in providing real-time, non-invasive, cellular-resolution imaging of skin using a handheld device.
2024-05
FinSMEs
Enspectra Health Secures $30 Million in Series C Funding to Advance VIO Skin Imaging System
Enspectra Health announced it has raised $30 million in Series C funding, which will be used to accelerate the commercialization and further development of its VIO Skin Imaging System.
2023-09
MedTech Outlook
Enspectra Health's VIO System Aims to Revolutionize Skin Cancer Detection
MedTech Outlook features Enspectra Health's VIO System, discussing its innovative approach to non-invasive, real-time imaging for early skin cancer detection and improved patient outcomes.
2023-08
Enspectra Health (Press Release)
Enspectra Health Receives FDA 510(k) Clearance for VIO Skin Imaging System
Enspectra Health announced that its VIO Skin Imaging System has received 510(k) clearance from the U.S. Food and Drug Administration, marking a significant milestone for commercialization.
2023-06
The Dermatologist
VIO Skin Imaging System: A New Era in Dermatological Diagnostics
The Dermatologist discusses the VIO Skin Imaging System, highlighting its potential to usher in a new era of dermatological diagnostics by providing high-resolution, real-time imaging for clinicians.
2023-07
Enspectra Health (Press Release)
Enspectra Health Showcases VIO Skin Imaging System at American Academy of Dermatology Annual Meeting
Enspectra Health announced its participation in the American Academy of Dermatology Annual Meeting, where it showcased the VIO Skin Imaging System to a broad audience of dermatological professionals.
2023-03

Videos

Product demos, reviews, and walkthroughs for VIO Skin.

View all on YouTube

Frequently Asked Questions

VIO Skin is designed to seamlessly integrate with common EHR systems and imaging devices, allowing physicians to upload images for AI analysis directly within their current workflow. It provides an assistive layer for initial assessments, flagging potential concerns or categorizing lesions for further review.
VIO Skin employs robust encryption protocols for data transmission and storage, adhering to HIPAA regulations for protected health information. It also utilizes de-identification techniques where appropriate to safeguard patient privacy during AI model training and analysis.
While VIO Skin demonstrates high accuracy for common dermatological conditions, its performance may vary for extremely rare conditions due to limited training data. Efforts are continuously made to improve its generalizability across diverse skin tones and ethnicities to mitigate potential biases.
VIO Skin complements traditional dermatoscopy by offering rapid, AI-driven preliminary analysis, potentially reducing the time spent on initial screenings. Compared to other AI tools, it focuses on a comprehensive range of skin conditions with a strong emphasis on explainability and physician oversight.
VIO Skin typically offers subscription-based pricing tiers, which may include per-user or per-analysis models, with potential discounts for multi-year commitments. We are exploring flexible options and grant programs for smaller practices and academic research institutions to ensure broader accessibility.
VIO Skin is undergoing the necessary regulatory review processes, including seeking FDA clearance, for its intended use as a clinical decision support tool. It is currently intended as an assistive technology, not a standalone diagnostic device, and should be used under physician supervision.
Comprehensive training modules, including online tutorials and live webinars, are provided to ensure physicians and staff can effectively integrate VIO Skin into their practice. Ongoing technical support and clinical guidance are also available to address any usage questions or concerns.
VIO Skin is developed with a strong commitment to ethical AI, employing diverse and representative datasets during training to minimize algorithmic bias. Regular audits and continuous monitoring are conducted to identify and mitigate any emerging biases, ensuring equitable performance across all patient populations.

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Suggest an Edit → | Last Verified: 2026-04-22 | First Added: 2026-04-22

Investors who backed VIO Skin

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