NEVISENSE
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
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
|
| Deployment | On-premise device |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown 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: PositiveStrengths
- 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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