NEVISENSE

by SCIBASE AB  · Based in Sweden → — Pioneering prediction and prevention in dermatology with AI and EIS.
Dermatology

Paid
Regulatory Status Disclosed

Overview

Nevisense, developed by SciBase AB, is a unique, non-invasive, and FDA-approved point-of-care platform that combines Electrical Impedance Spectroscopy (EIS) and Artificial Intelligence (AI) to provide in-depth skin analysis. It is designed to enhance diagnostic accuracy, facilitate disease monitoring, and enable early detection of skin cancer and other skin disorders.

The device works by sending tiny, harmless electrical impulses into the skin’s surface to measure electrical impedance, which reflects cellular structure, shape, and size beneath the skin – information not accessible through visual examination alone. This objective data complements a physician’s clinical evaluation and patient history, aiding in more informed biopsy management decisions for atypical pigmented skin lesions.

The Nevisense system comprises a control unit with a 12-inch touchscreen, a probe, and proprietary disposable electrodes. These electrodes feature microinvasive pins that ensure optimal contact and comprehensive measurement across multiple depths. The platform processes 700 data points per measurement, displaying results at the point-of-care.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Electrical Impedance Spectroscopy (EIS) technology
  • AI-powered diagnostic support
  • Non-invasive measurement
  • Point-of-care results
  • Objective diagnostic information
  • Disposable electrodes with microinvasive pins
  • 12-inch touchscreen control unit
  • Data export capabilities (to Excel)
  • Measures cellular characteristics beneath skin surface
  • Supports melanoma, non-melanoma skin cancer, and skin barrier assessment

Use Cases

  • Aiding in the detection of malignant melanoma
  • Assessing atypical pigmented skin lesions prior to biopsy decision
  • Detection of non-melanoma skin cancer
  • Skin barrier assessment and research
  • Disease monitoring in dermatology
  • Reducing unnecessary biopsies

What Physicians Need to Know

Key Capabilities
Utilizes Electrical Impedance Spectroscopy (EIS) combined with AI to provide objective, non-invasive analysis of skin lesions for melanoma detection, keratinocyte cancer, and skin barrier assessment. It detects structural changes in tissue and provides an immediate risk score (0-10) indicating atypia.
Clinical Utility
Complements visual and dermoscopic examination, aiding physicians in making more informed decisions on excising suspicious lesions, particularly in uncertain cases. It has demonstrated a potential to reduce unnecessary excisions by up to 34% and increases diagnostic accuracy for melanoma. Approved for use on children.
Integration Options
Nevisense View allows connection with digital dermoscopes and cameras via Wi-Fi or USB. It integrates with DermoScan's DermoGenius Ultra system for sharing patient data and EIS measurements, and can link to common Electronic Health Record (EHR) systems in Germany. Nevifile software and Nevisense Dashboard enable comprehensive data storage, review, and export.
Compliance Status
CE marked in Europe, FDA cleared/approved in the US for melanoma detection, and TGA approved in Australia. It is included in the US NCCN Clinical Practice Guidelines for melanoma and has been granted a Category III CPTu00ae code by the AMA. FDA has approved extended labeling to allow other healthcare professionals (e.g., PAs, MAs) to perform the procedure under dermatologist initiation.
Pricing Model
Based on an initial purchase of the Nevisense device (approx. EUR 5,000-6,000 in EU, USD 7,500 in USA as of 1/2024) followed by recurring sales of disposable electrodes (approx. EUR 41 in EU, USD 69 in USA as of 1/2024), which are the primary revenue source. A Self-Pay Program has been launched in the US to enhance patient access, and increased US Medicare fee schedules have been published in certain regions.
User Experience
The procedure is non-invasive, painless, and quick, providing results within seconds on a touchscreen display. Recent versions (Nevisense 3.0/V) offer intelligent guidance, improved user feedback, and streamlined workflow by often eliminating the need for a separate reference measurement. It is portable and helps provide objective clarity for patients.
Support Quality
While specific support quality details are not extensively highlighted, SciBase is a global medical technology company. The device requires successful completion of Nevisense training for users, indicating a structured approach to user education and competency.
Implementation Complexity
Requires training for physicians and other authorized healthcare professionals. The procedure involves moistening the skin and performing measurements, but is designed to integrate easily into existing clinical workflows. The device is portable, facilitating flexible placement within a clinic.
Evidence Base
Built on over 20 years of research from the Karolinska Institute, with extensive development and validation involving over 4,000 patients. A pivotal study (SIMPS) on 2,416 lesions demonstrated 96.6-97% sensitivity for malignant melanoma and 34-34.4% specificity. Its efficacy is further supported by FDA approval, inclusion in NCCN Guidelines, a US consensus report, and multiple peer-reviewed publications.
Physician Tip

Nevisense serves as a valuable adjunctive diagnostic tool, particularly for 'gray area' lesions where visual assessment alone is inconclusive. It provides objective data that can enhance diagnostic confidence, potentially reduce unnecessary excisions, and improve patient communication. Ensure proper training and adherence to measurement protocols for optimal accuracy. Consider its utility in pediatric dermatology and for longitudinal monitoring of suspicious lesions. The expanded labeling now allows trained physician assistants and medical assistants to perform the measurements, streamlining clinic workflow once a dermatologist initiates the test.

Nevisense offers practical integration capabilities, notably with digital dermoscopy systems like DermoScan's DermoGenius Ultra, allowing for a unified workflow that combines EIS scores with clinical and dermoscopic images. Patient data and results can be shared, and the system can connect to common EHRs. The Nevisense View and Nevifile software provide robust solutions for image and data management, and the Nevisense Dashboard facilitates data visualization and export for further analysis.

Details

Category Dermatology AI
Pricing Paid
  • Device purchase required (EUR 5,000–6,000 in EU; USD 7,500 in USA); Recurring cost for disposable electrodes (approx
  • EUR 41 in EU; USD 69 in USA)
DeploymentOn-premise device
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Nevisense received Pre-Market Approval (PMA Number P150046) from the FDA on June 28, 2017. It is indicated for use on cutaneous lesions with one or more clinical or historical characteristics of melanoma, when a dermatologist chooses to obtain additional information when considering biopsy. It should not be used on clinically obvious melanoma.

Integrations
EHR Not specified
Specialties Dermatology

What the Web Says

NEVISENSE, developed by SciBase, is an AI-driven, FDA-approved, non-invasive electrical impedance spectroscopy (EIS) system designed to improve the early detection of melanoma and other skin cancers. Physicians and studies indicate that Nevisense significantly enhances diagnostic accuracy and clinician confidence, particularly in evaluating atypical pigmented lesions and reducing unnecessary biopsies. The latest version, Nevisense 3.0, offers streamlined measurements, increased reproducibility, and higher accuracy.

Overall: Positive

Strengths

  • Significantly improves early detection of melanoma and other skin cancers.
  • Increases diagnostic accuracy and clinician confidence.
  • Reduces the number of unnecessary excisions/biopsies of benign lesions.
  • Non-invasive procedure, which is beneficial for patients with needle phobia.
  • Approved for use on children and effective on pigmented skin types (e.g., skin type IV).
  • Streamlined workflow and easier integration into clinic practice with Nevisense 3.0.

Limitations

  • Potential for false negative results, which could delay diagnosis and treatment.
  • Safety and effectiveness not established for patients aged 30 and below, or with Fitzpatrick Skin Type 5 and 6.
  • Requires dermatologists to complete specific training for use.
  • Should not be used on lesions already determined to require biopsy.
  • Some Reddit users express skepticism about the accuracy of AI-driven diagnostic tools in general.
  • Main uncertainties relate to the timing of insurance coverage ramp-up and speed of technology adoption.

Based on reviews from: Inderes.se, SciBase, PR Newswire, PubMed Central (PMC), accessdata.fda.gov, Reddit, Targeted Oncology

Last updated: 2026-07-20

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Videos

Product demos, reviews, and walkthroughs for NEVISENSE.

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Frequently Asked Questions

Nevisense is a non-invasive, point-of-care adjunct tool that uses Electrical Impedance Spectroscopy (EIS) combined with AI to provide objective data on suspicious lesions. It helps you make more informed decisions about whether to proceed with a biopsy, complementing your visual examination and patient history.
Nevisense is FDA-approved and CE-marked as a medical device for melanoma detection. While specific data privacy protocols for Nevisense aren't detailed in the search results, general ethical considerations for AI in dermatology emphasize transparent patient communication about AI's role and limitations, and robust data protection procedures in compliance with regulations like HIPAA.
Nevisense is not intended for lesions already clearly requiring biopsy based on clinical evaluation. Its safety and effectiveness have not been established in patients under 30 years old or those with Fitzpatrick Skin Types 5 and 6. There is a potential for false negative and false positive results, and it requires trained dermatologists for accurate use.
Other non-invasive diagnostic support tools for melanoma include Pigmented Lesion Assay (PLA), Reflectance Confocal Microscopy (RCM), and Gene Expression Profile (GEP) tests. Nevisense uniquely combines EIS with AI to provide structural data from beneath the skin's surface, aiding in biopsy decisions for clinically challenging lesions.
The Nevisense device itself costs approximately EUR 5,000-6,000 in the EU and USD 7,500 in the USA. The primary recurring cost comes from consumable electrodes, priced around EUR 41 in the EU and USD 69 in the USA per test. Medicare fee schedules exist in some US regions, and a self-pay program has been introduced to improve patient access.
Nevisense provides an Electrical Impedance Spectroscopy (EIS) score, typically from 0-10, which gives additional information to the physician about the likelihood of a mole being melanoma. While the AI's internal workings are complex, the output is a clear score that complements clinical judgment, allowing physicians to explain the objective data to patients as part of the overall diagnostic process.

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Suggest an Edit → | Last Verified: 2026-04-20 | First Added: 2026-04-20
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