What Diagnosys does

Diagnosys LLC is a privately held, Massachusetts-based medical device company founded in 1985 that designs, manufactures, and sells clinical and preclinical visual electrophysiology systems used to diagnose and monitor retinal and optic nerve disease. Its clinical product portfolio spans the ColorDome Ganzfeld stimulator, ColorFlash handheld stimulator, Envoy pattern stimulator, Luminous Intelligence display monitor, and three console configurations (E3, Profile, and Standalone), all unified by the proprietary Espion software platform that performs ISCEV-standard tests (ERG, VEP, mfERG, PERG, EOG, FST, dark adaptometry, pupillometry). The company also offers the Celeris preclinical system for rodent and large-animal testing, a full line of single-use electrodes and accessories, and dedicated clinical trial services that have supported more than 100 trials over 35 years.

Diagnosys sells direct to enterprise customers — primarily academic medical centers, specialized eye hospitals, pediatric ophthalmology programs, and pharmaceutical/CRO sponsors running retinal and gene therapy trials — through a consultative, quote-based sales motion with no publicly disclosed pricing. Marquee installed-base accounts include Bascom Palmer, Cleveland Clinic, Mayo Clinic, Moorfields, Wilmer, Great Ormond Street Hospital, and Peking University Hospital, alongside clinical research collaborators such as Spark Therapeutics (Novartis) and Atsena Therapeutics. Distribution is direct with no resellers; the company maintains a UK affiliate (Diagnosys UK Ltd.) for EMEA sales and support, and has registered trademarks in the US, EU, UK, China, and elsewhere.

The business model blends hardware sales (consoles, stimulators, electrodes), recurring software licensing/updates (Espion V7), professional services (clinical trial setup, training, data review), and ongoing calibration/support contracts. Regulatory positioning is a defining asset: Diagnosys is ISO 13485:2016 and MDSAP certified, FDA 510(k) cleared, CE marked, and holds country-specific approvals across Australia, Canada, Japan, China, and the US, enabling global shipment of medical-grade electrophysiology equipment.

Name

Diagnosys

Legal name

Diagnosys LLC

Website

https://diagnosysllc.com

Company type

Private

Founded year

1985

Operating status

Operating

Headcount range

11–50 employees

Short description

Diagnosys LLC designs, manufactures, and sells clinical and preclinical visual electrophysiology systems, including ColorDome, ColorFlash, Envoy stimulators, Espion software, and the DiagnosysFST, serving eye hospitals, research institutions, and pharma/CROs running retinal and gene therapy trials worldwide.

Ownership category

akta.pro rank

Product category

Ophthalmic Diagnostic Equipment

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Navigational, Measuring, Electromedical, and Control Instruments Manufacturing (33451)

SIC

Electromedical & Electrotherapeutic Apparatus (3845), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Visual Field & Functional Vision Testing (Perimetry, ERG/VEP, Contrast Sensitivity) (HLAHAJAC)

akta.pro secondary industries

Ocular Imaging & Diagnostic Testing Centers (HLAKAKAN), Neuro-Ophthalmology (HLAKAKAH), Medical-Grade Displays (Diagnostic/Clinical) (HDACADAJ)

Keywords

• Visual electrophysiology systems
• Ophthalmic diagnostic devices
• Electroretinography equipment
• Clinical trial services
• Preclinical visual testing

Headquarters

HQ city

Lowell

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Supply Chain, Marketing or Sales, Infrastructure

Revenue model

1. Clinical Visual Electrophysiology Systems: Sale of complete diagnostic systems including consoles (E3, Profile, Standalone), stimulators (ColorDome, ColorFlash, Envoy), and accessories. Systems are sold directly to healthcare institutions and research facilities with pricing based on configuration and consultative sales process.
2. Software Licenses and Updates: Espion visual electrophysiology software included with all systems, with ongoing software releases and updates. Software generates DICOM-compatible outputs and supports regulatory compliance requirements.
3. Clinical Trial Services: Specialized services supporting clinical trials including trial setup assistance, training for data collection across multiple locations, and results review. The company claims 35 years of experience supporting clinical trials.
4. Consumables and Accessories: Single-use electrodes (DTL Plus, ERG Jet, skin electrodes), conductive pastes, gels, electrode preparation products, and replacement parts for clinical and preclinical testing equipment.
5. Equipment Calibration and Support: Ongoing customer support services including equipment calibration, software updates, training, and technical assistance to maintain regulatory compliance and optimal system performance.

Go-to-market motion3 records

Distribution channels1 record

Marketing channels7 records

Core offering

Diagnosys designs, manufactures, and sells clinical and preclinical visual electrophysiology systems used by hospitals, eye clinics, and research institutions to diagnose and monitor retinal and optic nerve diseases. Its portfolio includes console-based systems (E3, Profile, Standalone), visual stimulators (ColorDome, ColorFlash, Envoy), the Espion software platform, the DiagnosysFST testing system, and a line of clinical and preclinical electrodes and accessories. The company also provides clinical trial support services with multi-site training and data review across more than 100 trials worldwide.

Product overview

Diagnosys offers a comprehensive visual electrophysiology portfolio consisting of clinical and preclinical testing systems. The clinical lineup includes the ColorDome Ganzfeld stimulator, ColorFlash handheld stimulator, E3 Console, Profile System (cart-based), and Standalone Console, all powered by Espion software supporting all ISCEV standard tests. Add-on modules extend capabilities for Dark Adaptometry and Pupillometry. The DiagnosysFST system provides full-field stimulus testing for advanced retinal disease assessment. Preclinical offerings include the Celeris system for animal testing. Accessories include DTL Plus electrodes and comprehensive clinical/preclinical electrode and accessory lines. Trial services support clinical research with training and multi-location data collection.

Differentiator

Problem solved

Functional benefit

Brands

• Celeris: Preclinical visual electrophysiology testing system for small to large-sized animals, featuring integrated visual stimulators and electrodes.
• ColorDome
• Espion
• ColorFlash
• DiagnosysFST

Products and services

• ColorDome Stimulator Advanced Ganzfeld stimulator with self-calibrated flashes in multiple colors and intensities, trillion-to-one luminance range, and support for all ISCEV standard tests including full-field ERG, VEP, EOG, FST, dark adaptometry, and pupillometry. Designed for clinical and research use in ophthalmology.
• ColorFlash Stimulator Handheld visual flash stimulator with flash luminance from 0.01 to 1,000 cd·s/m2, designed for pediatric testing and supine-position patients, with built-in animal sounds for child engagement.
• E3 Console Compact tabletop visual electrophysiology console designed for research labs or clinics, with optional travel case for portability. Captures and processes electrophysiological signals.
• Profile System Cart-based two-cart visual electrophysiology clinical system for testing in both supine and seated positions, compatible with ColorDome and ColorFlash stimulators.
• Standalone Console Low-cost platform optimal for psychophysical tests including the Full-field Stimulus Test (FST), designed as a clinical endpoint for gene therapy trials.
• Envoy Pattern Stimulator Portable pattern stimulator weighing less than one pound for PERG, pattern VEP, and 19-hexagon mfERG testing, featuring OLED display with calibrated luminance exceeding 500 cd/m2 and sub-1ms response time.
• Display Monitor with Luminous Intelligence Artifact-free LCD monitor with brightness exceeding 1,000 cd/m2 and 1000:1 contrast ratio, eliminating flash artifacts in visual pattern reversal tests for accurate spatial and temporal retinal measurements.
• Espion Software Visual electrophysiology software platform supporting all ISCEV standard tests with data encryption, audit trails, normative reference comparison, and DICOM-compatible outputs. Used across all Diagnosys clinical and preclinical systems.
• DiagnosysFST Full-field Stimulus Test system for assessing light sensitivity thresholds in patients with advanced retinal degeneration, used as a clinical endpoint in gene therapy trials including Luxturna and RUSH2A studies. Completes each test in 1-2 minutes.
• Celeris Preclinical System Preclinical visual electrophysiology system for rodent and large animal testing with integrated visual stimulators and electrodes, designed for small- to large-sized animal vision research and drug discovery.
• Trial Services Clinical trial support services with 35 years of experience supporting more than 100 clinical trials, including data collection training across multiple locations worldwide and results review.
• Dark Adaptometry Module Add-on module for ColorDome to perform full or partial field dark adaptometry tests measuring cone sensitivity, rod sensitivity, and rod-cone break.
• Pupillometry Add-on Camera-based pupillometry module for ColorDome to assess rod, cone, and melanopsin pathways via pupillary light reflex.
• DTL Plus Electrodes Single-use, highly conductive silver/nylon thread corneal electrode for ERG testing, providing high conductivity and patient comfort.
• Clinical Accessories Comprehensive line of clinical accessories including skin electrodes, gold cup electrodes, conductive paste, DTL extender cables, red filters, and travel cases.
• Preclinical Accessories Preclinical accessories including D166 stainless steel electrodes, D198 electrode ball assembly, D233 rabbit ERG jet electrodes, D200 gold wire electrodes, and D362 Celeris travel case.

Quantifiable outcome

• Amplifier resolution of as little as 1 nanovolt for detecting faintest electroretinograms
• +3 more outcomes

Named customers19 records

Segments6 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature8 records

Partnerships

One partnership is on record.

• BioMedixminorGTM or Marketing PartnerDiagnosys co-hosts a visual electrophysiology masterclass webinar series with BioMedix, combining educational content for the visual electrophysiology community. This is a joint educational/marketing partnership rather than a commercial product integration.

Scale indicators5 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• LKC Technologies: US-based manufacturer of visual electrophysiology and ERG devices (including the RETeval flash ERG acquired in 2024). Directly competes with Diagnosys in clinical ERG, flash ERG, and clinical trial endpoint markets.
• Roland Consult: German manufacturer of electrophysiology equipment including RETI-port/scan systems for ERG, VEP, and multifocal ERG. A long-standing direct competitor in the visual electrophysiology specialty, serving academic and clinical customers globally.
• Metrovision: French developer of clinical visual electrophysiology systems (MonPackONE, ColorFlash-style stimulators). Directly competes with Diagnosys in ERG, VEP, and psychophysical testing for ophthalmology and neurology.
• Konan Medical: Specialist ophthalmic diagnostic company offering specular microscopy, cell density analysis, and visual function testing devices. Overlaps with Diagnosys in objective functional vision assessment for clinical and research use.

Emerging players

• Evoq Technologies: Emerging ERG device company that received FDA 510(k) clearance for its SmartERG platform in November 2024. Targets the same clinical electrophysiology endpoints as Diagnosys, including gene therapy trial use cases.

Broad incumbents

• Heidelberg Engineering: Large ophthalmic diagnostic imaging incumbent (OCT, confocal microscopy) used alongside visual electrophysiology. Competes broadly in the ophthalmic diagnostic workflow rather than head-to-head in ERG/VEP.
• Carl Zeiss Meditec: Global ophthalmic device and diagnostics incumbent spanning imaging, laser, and IOLs. Provides competing diagnostic modalities (OCT, perimetry) and operates in the same hospital eye departments as Diagnosys.
• Nidek: Japanese ophthalmic and optometric equipment manufacturer offering a broad diagnostic portfolio including retinal imaging and functional testing. A broad incumbent in the ophthalmic clinic where visual electrophysiology is performed.

Others

• Cadwell Industries: Neurodiagnostic equipment maker (EEG, EMG, IOM, sleep) overlapping with Diagnosys's neuro-ophthalmology / VEP applications. Adjacent category rather than a direct ERG competitor.
• Natus Medical: Broad neurodiagnostic and newborn screening equipment company. Overlaps with Diagnosys where visual evoked potentials intersect with neurophysiology labs and neurology practices.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• YouTubeyoutube.com/user/DiagnosysLLC
• LinkedInlinkedin.com/company/diagnosys-llc
• Xx.com/diagnosysllc

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Subsidiaries1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Diagnosys