Enspectra Health

2495 Hospital Drive, Suite 300, Mountain View, CA 94040, United States  All United States companies → Founded 2014
Imaging AI Specialist Medical Device / Hardware Specialty-Focused AI
Dermatology Pathology
Dermatology AI
Venture Capital-Backed (Series A and Grants) — $13.5M

Products

VIO Skin
Enspectra Health
Dermatology AI
An AI-powered imaging platform with FDA 510(k) clearance for its VIO System and Breakthrough Device Designation for the VIO Skin Platform, designed to assist clinicians in evaluating skin lesions non-invasively.

See all 1 product →

About Enspectra Health

Enspectra Health is at the forefront of digital dermatology, pioneering the field of virtual biopsies with its innovative VIO™ Skin Platform. This FDA-cleared, handheld, cross-modal imaging technology is designed to transform how physicians evaluate a broad spectrum of skin conditions. The VIO System integrates reflectance confocal microscopy with multiphoton laser scanning microscopy to generate real-time, high-resolution, multispectral images of cellular structures in living skin, eliminating the need for an incision.

This technology provides immediate digital pathology insights, allowing dermatologists and pathologists with skin histology training to visualize various tissue features, including blood vessels, collagen, pigment, stratum corneum, hair follicles, and cellular atypia, to assist in forming a clinical judgment. The primary goal is to minimize unnecessary traditional biopsies, facilitate earlier disease diagnosis, and streamline the evaluation of skin conditions, particularly non-melanoma skin cancers like basal cell carcinoma (BCC) and squamous cell carcinoma (SCC).

Enspectra Health further leverages artificial intelligence and machine learning to develop advanced applications from its imaging data. Notably, its VIO.ai NMSC software function recently received FDA Breakthrough Device Designation for lesion classification, providing computer-aided diagnosis and triage (CADx/CADt) to support physicians in clinical decision-making for suspicious BCC and SCC in high-risk populations. The company aims to digitize the entire dermatological evaluation process, extending its platform’s utility to general skin health assessment, photoaging, and evaluating the efficacy of topical drugs for various dermatological conditions.

Focus Areas

Non-invasive skin imaging virtual biopsies digital pathology skin cancer detection dermatology AI-powered clinical decision support multiphoton microscopy reflectance confocal microscopy

Business Intelligence

Key InvestorsTsingyuan Ventures, Foothill Ventures, Joyance Partners, National Cancer Institute (NIH)
PartnershipsGolden State Dermatology, Fogarty Innovation
TechnologyVIO System, combines reflectance confocal microscopy and multiphoton microscopy, handheld device, AI-powered VIO™ Skin Platform (VIO) with VIO.ai NMSC (Computer-Aided Diagnosis and Triage software)
FDA Clearances1 cleared products (estimated)

What Physicians Need to Know

Non-invasive Skin Imaging
Enspectra Health specializes in advanced non-invasive skin imaging, offering a significant alternative to traditional invasive biopsies. This approach aims to reduce patient discomfort, eliminate scarring, and provide rapid insights into skin conditions.
Virtual Biopsies & Digital Pathology
Leveraging cutting-edge technology, Enspectra Health enables 'virtual biopsies,' transforming the diagnostic workflow. Their digital pathology capabilities allow for detailed analysis and remote consultation, enhancing efficiency and accessibility.
Skin Cancer Detection
A core focus is on early and accurate skin cancer detection. By providing high-resolution, real-time imaging, the technology assists dermatologists in identifying suspicious lesions with greater precision, potentially leading to earlier intervention.
AI-Powered Clinical Decision Support
Enspectra Health integrates AI into its platform to provide intelligent clinical decision support. This AI augmentation helps physicians interpret complex imaging data, prioritize cases, and make more informed diagnostic and treatment decisions.
Advanced Microscopy Technologies
The company utilizes sophisticated imaging modalities, including Multiphoton Microscopy and Reflectance Confocal Microscopy. These technologies provide cellular-level detail of skin tissue without the need for excision, offering unprecedented insights.
Physician Tip

For physicians, Enspectra Health's technology offers a paradigm shift in dermatological diagnostics. Consider integrating this for patients who are anxious about traditional biopsies, those with lesions in cosmetically sensitive areas, or for rapid initial assessment to streamline your workflow. The AI-powered decision support can act as a valuable second opinion, enhancing diagnostic confidence and potentially reducing unnecessary excisions. Emphasize the non-invasive nature and speed of results to patients to improve their experience and compliance.

Enspectra Health's platform is designed with potential for seamless integration into existing clinical workflows. This includes compatibility with Electronic Health Record (EHR) systems for streamlined patient data management, Picture Archiving and Communication Systems (PACS) for image storage and retrieval, and potentially telemedicine platforms for remote consultations and second opinions, enhancing interoperability within a modern dermatology practice.

Products by Enspectra Health

1 product in the directory

VIO Skin
Enspectra Health
Dermatology AI
An AI-powered imaging platform with FDA 510(k) clearance for its VIO System and Breakthrough Device Designation for the VIO Skin Platform, designed to assist clinicians in evaluating skin lesions non-invasively.

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Press & Coverage

PR Newswire
Enspectra Health Receives FDA Breakthrough Device Designation for AI-powered Imaging Platform Targeting Skin Cancer
Enspectra Health announced that its AI-powered VIOu2122 Skin Platform received FDA Breakthrough Device Designation for evaluating lesions suspicious of basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) in high-risk populations. This designation aims to expedite the development and review process for technologies that offer more effective treatment options.
2024-06
BioSpace
Enspectra Health Announces US FDA Clearance of VIOu2122 System, First of Its Kind Technology to Visualize Skin Cellular Structures in Real-Time
Enspectra Health received FDA 510(k) clearance for its VIO System, a noninvasive imaging technology combining reflectance confocal and multiphoton microscopy to provide real-time, cellular-resolution images of skin. This marks a new era in noninvasive imaging, allowing for instantaneous evaluation of digital pathology images.
2024-01
PR Newswire
Enspectra Health's groundbreaking cross-modal platform pioneers transformation in the field of skin health
Enspectra Health announced the publication of its cross-modal imaging technology in Scientific Reports, a Nature Research journal. This publication details their novel method for real-time visualization of skin cellular structure and composition, which has also received FDA clearance.
2024-11
Fogarty Innovation
Enspectra Health Catapults to Next Level with FDA Clearance
Enspectra Health's VIO System received its first FDA clearance, making it the first new FDA-cleared modality in approximately 25 years to employ multiphoton microscopy. The portable, handheld device provides high-resolution images of cellular structures in living skin without incisions.
2024-03
Medical Startups
Understanding MedTech Regulation Through FDA Device Authorization
This article highlights Enspectra Health's FDA clearance for its VIO System in January as a notable instance in MedTech regulation. It discusses the importance of early regulatory considerations in device development.
2024-01
PMC (Scientific Reports)
Handheld multiphoton and pinhole-free reflectance confocal microscopy enables noninvasive, real-time cross-sectional imaging in skin
This peer-reviewed article details Enspectra Health's handheld cross-modal imaging technology, which combines multiphoton and pinhole-free reflectance confocal microscopy for noninvasive, real-time, cross-sectional imaging of skin. The research was supported by Enspectra Health and the National Cancer Institute.
2024-10
PR Newswire
Enspectra Health Awarded Second Tranche of $4.0 Million NIH Grant to Advance its Virtual Biopsy Technology
Enspectra Health received a second tranche of $1.2 million as part of a $4.0 million Phase IIB grant from the NIH's SBIR Program. This funding supports the advancement of their novel imaging technology for evaluating nonmelanoma skin cancers.
2022-03
Fogarty Innovation
Enspectra Health Completes Enrollment for Pivotal Clinical Study, Sets Sights on Ambitious Next Steps
Enspectra Health completed enrollment for its VISTA US Pivotal Study, a multicenter trial evaluating the safety and effectiveness of the VIO System for non-invasive skin imaging. The company is now working towards FDA clearance and raising its next financing round.
2023-04

Frequently Asked Questions

Enspectra Health's flagship product, the VIO System, utilizes a novel combination of multiphoton microscopy (MPM) and reflectance confocal microscopy (RCM) to provide real-time, high-resolution, histology-like images of cellular structures in living skin. This handheld device enables non-invasive visualization of various skin components, such as collagen, pigment, and cellular atypia, directly from the patient's skin.
The VIO System aims to transform dermatology by offering a 'virtual biopsy' capability, allowing physicians to non-invasively evaluate skin conditions and potentially reduce the need for traditional surgical biopsies. It provides immediate access to cellular and pathological information, assisting in earlier disease diagnosis and the assessment of lesions suspicious for basal cell carcinoma (BCC) and squamous cell carcinoma (SCC).
Yes, Enspectra Health's VIO System received FDA 510(k) clearance in January 2024 for acquiring, storing, and displaying in vivo images of tissue features to assist physicians in clinical judgment. Furthermore, their AI-powered VIO Skin Platform, which integrates with VIO.ai NMSC software for lesion classification, has been granted FDA Breakthrough Device Designation for evaluating suspicious BCC and SCC lesions in high-risk populations.
Enspectra Health is actively advancing AI/ML clinical decision support models, exemplified by their VIO.ai NMSC software, which provides lesion classification to aid physicians in decision-making. They are also developing deep learning algorithms to predict the progression of precancerous lesions like Actinic Keratosis to squamous cell carcinoma, leveraging multimodal imaging data.
Enspectra Health has engaged in clinical study partnerships with institutions like Golden State Dermatology for trials such as VISION and VISTA, and licenses technology from Stanford University. The company is privately held and has secured significant funding, including over $15.5 million across various rounds and grants from the National Institutes of Health (NIH) and National Cancer Institute (NCI), indicating a strong commitment to research and development.
Enspectra Health's primary product is the VIO System, a handheld, non-invasive imaging device that combines multiphoton and reflectance confocal microscopy for real-time cellular-level visualization of skin. They are also developing the AI-powered VIO Skin Platform, which integrates the VIO technology with AI software for enhanced clinical decision support in evaluating skin lesions.
Specific pricing details for Enspectra Health's VIO System are not publicly disclosed and would typically be obtained through direct inquiry with the company. As a medical device company, it is standard to expect comprehensive professional support, including onboarding, training, and ongoing assistance to ensure effective integration and utilization of their technology in clinical practice.

Investors

Who's funded Enspectra Health.

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