Clear Guide Medical

What Clear Guide Medical does

Clear Guide Medical is a privately-held medical-device company headquartered in Baltimore, Maryland, founded as a spin-out of Johns Hopkins Medical Institutions and The Johns Hopkins University (the first startup in JHU's FastForward incubator). The company develops vision-based, computer-assisted interventional navigation systems that fuse CT or MRI imaging with real-time ultrasound to provide augmented-reality (AR) instrument guidance for minimally invasive needle-based procedures. Its core platform, the CLEAR GUIDE SCENERGY suite, combines a probe-mounted stereo-camera attachment (SuperPROBE), a central processing unit (CORE), an optical head, and SCENERGY software (Navigation and Fusion sub-features) to enable automatic and continuous multi-modality registration in under 10 seconds and simultaneous tracking of up to six instruments using existing ultrasound equipment. The product family extends to SCENERGY TP (transperineal guidance for prostate and pelvic procedures), the LUMENA AR system (MRI-suite interventions), the EDU training and assessment device, and consumable accessories (VisiMARKERs I and II, TipTAGS, SteriMASK), with the legacy Clear Guide ONE as a predecessor device.

The platform is supported by six FDA 510(k) clearances, CE Mark registration, and ISO 13485:2016 certification, and is validated for use with a wide range of existing ultrasound platforms (GE, Philips, Siemens, SonoSite, BK, Mindray, ZONARE, Ultrasonix, Interson). Clinical evidence is anchored in 40+ peer-reviewed publications and patents, with reported clinical accuracy of 1.46±0.78mm in a 30-patient prostate study, 2.6±0.6mm in a cadaver LUMENA study, and resident-reported 67% confidence and 94% speed/accuracy improvement at Johns Hopkins.

Clear Guide Medical generates revenue through one-time capital-equipment sales of the SCENERGY hardware systems to clinicians, researchers, and academic medical centers, supplemented by recurring consumables (VisiMARKERs, TipTAGS, SteriMASK), and historically by non-dilutive R&D funding from NIH, NSF, NIBIB, and Maryland TEDCO. Disclosed funding totals approximately $8.8M ($3.8M NIH in 2015, $3.0M from Wildermuth Advisory in 2016, and $2.0M NIH in 2018). The company distributes through direct inside-sales channels in the US (Baltimore headquarters) and Europe, a website-driven 'Schedule a Demo' funnel, and a reorder quote form for consumables. It serves interventional radiology, urology, anesthesiology/pain management, emergency medicine, pediatric radiology, and academic research customers, with named users including Johns Hopkins Hospital, Mayo Clinic, Children's National Hospital, Mount Sinai Beth Israel, West Virginia University, Cooper University Hospital, and the Geneva Foundation / U.S. Army Institute of Surgical Research. The company is currently soliciting outside investment to support the build-out of international sales.

Name

Clear Guide Medical

Legal name

Clear Guide Medical Inc.

Website

https://clearguidemedical.com

Company type

Private

Founded year

2011

Operating status

Operating

Headcount range

11–50 employees

Short description

Clear Guide Medical is a privately-held Johns Hopkins spin-out that develops vision-based, AR-guided navigation systems fusing CT/MRI with ultrasound for image-guided biopsies, ablations, and other needle-based procedures. It sells capital hardware plus consumables to hospitals and academic medical centers in the US and Europe.

Ownership category

akta.pro rank

Product category

Image-Guided Interventional Medical Devices

NAICS

Surgical and Medical Instrument Manufacturing (339112), Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Medical Equipment and Supplies Manufacturing (3391), Navigational, Measuring, Electromedical, and Control Instruments Manufacturing (3345)

SIC

Surgical & Medical Instruments & Apparatus (3841), Ophthalmic Goods (3851), Optical Instruments & Lenses (3827), Electromedical & Electrotherapeutic Apparatus (3845)

akta.pro primary industry

Surgical Navigation, Tracking & Intraoperative Guidance (Ortho/Neuro/ENT) (HLAHADAG)

akta.pro secondary industries

Intraoperative Imaging & Guidance (C-arms, O-arm, IOUS, fluorescence) (HLAHADAH), Surgical Visualization & OR Video Integration (4K/3D, Recording, Routing) (HLAHADAD)

Keywords

• Image-guided intervention
• Medical imaging navigation
• Augmented reality surgery
• Ultrasound fusion systems
• Interventional radiology devices

Headquarters

HQ city

Baltimore

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Capital equipment sales (SCENERGY, SuperPROBE, CORE, Optical Head): One-time sale of navigation hardware systems to clinicians, researchers, and academic partners. Hardware includes SCENERGY, SuperPROBE, CORE computational unit, and Optical Head; available for immediate order via direct sales contact.
2. Consumables (VisiMARKER, TipTAG, SteriMASK): Recurring/ongoing reorder revenue from sterile disposable accessories. VisiMARKER I (Box of 25 Pouches, CG-VM), VisiMARKER II (Box of 15 Pouches, CG-VM2), TipTAG (Box of 10 Pouches, CG-TT), SteriMASK (Box of 20 Pouches, CG-SM). Ordered via reorder form for quote.
3. Investment funding (private): Privately-held company offering ongoing investment opportunities to support build-out of international sales. Capital sourced from grants (NIH, NSF, NIBIB, Maryland TEDCO) and private investment.

Pricing tiers

Go-to-market motion4 records

Distribution channels5 records

Marketing channels6 records

Core offering

Clear Guide Medical develops and sells the CLEAR GUIDE SCENERGY platform, a vision-based, probe-mounted optical stereo-camera navigation system combined with multi-modality image fusion software (SCENERGY Navigation and SCENERGY Fusion) that fuses ultrasound motion with CT/MRI clarity for AR-guided biopsies, ablations, and other needle-based interventional procedures. The offering is sold as hardware systems (SuperPROBE, CORE, Optical Head) augmented by consumable sterile accessories (VisiMARKERs, TipTAGS, SteriMASK) and supported by specialized sub-products such as SCENERGY-TP, the LUMENA AR System, and the EDU training system.

Product overview

Clear Guide Medical is a privately-held, Johns Hopkins spin-out medical imaging company that offers a single flagship platform — the CLEAR GUIDE SCENERGY suite of solutions — augmented by a set of hardware add-ons, consumable accessories, and specialized sub-products rather than a broad multi-product SaaS portfolio. The platform combines the CLEAR GUIDE SuperPROBE (a probe-mounted stereo-camera attachment), the CLEAR GUIDE CORE (central processing unit), and the CLEAR GUIDE Optical Head with the SCENERGY software, which delivers SCENERGY Navigation (real-time instrument guidance) and SCENERGY Fusion (CT/MR-to-ultrasound image fusion) for AR-guided biopsies, ablations, and other interventional procedures. This core platform is extended by the CLEAR GUIDE SCENERGY-TP (a transperineal variant for MRI-guided prostate/pelvic procedures), the LUMENA AR System (a separate AR navigation system designed for MRI-guided musculoskeletal and other interventions), the CLEAR GUIDE EDU training/evaluation system, and consumable lines including VisiMARKERs I & II, TipTAGS, and SteriMASK; the legacy CLEAR GUIDE ONE was the earlier-generation CAIG device from which the SCENERGY line evolved.

Differentiator

Problem solved

Functional benefit

Brands

• SCENERGY: The flagship CLEAR GUIDE SCENERGY product line — an ultrasound and CT/MRI image fusion and instrument guidance navigation system that works with the customer's existing ultrasound. Includes SCENERGY Navigation and SCENERGY Fusion sub-offerings.
• SCENERGY-TP
• LUMENA
• EDU
• Clear Guide ONE

Products and services

• CLEAR GUIDE SCENERGY Flagship AR-guided interventional navigation platform that fuses the clarity of CT/MRI with the motion of ultrasound to provide real-time image fusion and instrument guidance for biopsies, ablations, and other needle-based procedures. Works with a clinician's existing ultrasound equipment. Targeted at hospitals, interventional radiology departments, and academic medical centers.
• CLEAR GUIDE SCENERGY-TP Transperineal variant of CLEAR GUIDE SCENERGY that combines a transperineal guide grid with the SCENERGY software for MRI-guided prostate and pelvic procedures such as biopsy and cryoablation, with automatic registration and projected grid overlay. For urologists and interventional oncologists performing prostate and pelvic procedures.
• CLEAR GUIDE VisiMARKERs (I & II) Sterile on-patient multi-modality fiducial markers (VisiMARKER I visible in CT; VisiMARKER II visible in CT and MR) that enable automatic registration between imaging modalities in under 10 seconds and provide constant updating of registration throughout the procedure. Also usable by third-party medical devices for VR instrument tracking. Sold in boxes of 25 (VisiMARKER I, CG-VM) and 15 pouches (VisiMARKER II, CG-VM2).
• CLEAR GUIDE TipTAGS Instrument markers that, when attached to needles, ablation introducers, or syringes and shown to the cameras, allow the instrument tip to be visible in ultrasound and in CT/MRI and enable monitoring of insertion depth during the procedure. Sold in boxes of 10 pouches (CG-TT).
• CLEAR GUIDE SteriMASK Sterile disposable mask accessory (CG-SM, box of 20 pouches) used in CLEAR GUIDE procedures as part of the consumable product line.
• LUMENA AR System
• CLEAR GUIDE EDU Educational device for training and quantitative skills assessment of ultrasound-guided interventional procedures, with AI-based instrument guidance, custom course creation, and automated procedure logging/evaluation. Evaluated in studies of nursing and anesthesiology students. Targets medical training programs and academic medical centers.
• CLEAR GUIDE ONE (legacy) Earlier-generation computer-assisted instrument guidance (CAIG) device with probe-mounted miniature stereo cameras that provides probe-relative localization of needle-like instruments and overlays predicted needle trajectories on the ultrasound video stream; predecessor to the SCENERGY platform, FDA 510(k) cleared in 2014.

Quantifiable outcome

• 30-patient clinical study for SCENERGY TP showed 1.46±0.78mm average needle placement error at 67mm average depth
• +7 more outcomes

Named customers6 records

Segments6 records

Ideal customer profiles5 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration9 records

AI capability8 records

Feature9 records

Partnerships

Five partnerships are on record, tiered flagship and core.

• Johns Hopkins University / Johns Hopkins Medical InstitutionsflagshipStrategic or Co-development PartnerClear Guide Medical is a spin-out of Johns Hopkins Medical Institutions and The Johns Hopkins University. Co-founder Emad M. Boctor is Assistant Professor of Radiology, Computer Science, and Electrical and Computer Engineering at JHU and director of the Medical Ultrasound Imaging and Intervention Collaboration (MUSiiC) lab. Clinical Advisor Clifford R. Weiss is Associate Professor of Radiology at Johns Hopkins Hospital. President James J. Condon is Chairman of the Johns Hopkins Computer Science program's Advisory Board. Multiple research collaborations and publications co-authored with JHU researchers.
• Mayo CliniccoreStrategic or Co-development PartnerCollaboration on transperineal guide grid with optical fusion for MR-guided prostate biopsy and ablation. The transperineal guide grid with optical fusion was developed by Clear Guide Medical in collaboration with Mayo Clinic (David A. Woodrum, Scott M. Thompson, Daniel A. Adamo, et al.). Co-authored publication in Interventional MRI Symposium (October 2022).
• Children's National Hospital (Karun Sharma et al.)coreStrategic or Co-development PartnerCollaboration on the LUMENA AR system for MRI-guided interventions. First-in-human clinical trial (NCT#06224933) to evaluate feasibility and safety of the AR system in pediatric patients undergoing MRI-guided interventions. Co-authors include Karun Sharma, Ranjith Vellody, Kevin Cleary. The work was supported by NIH grant 5R44EB028722.
• Johns Hopkins FastForward IncubatorcoreOthersFirst startup company in Johns Hopkins' FastForward incubator; provided early-stage incubation for the company.
• Johns Hopkins University (LUMENA research collaboration)coreStrategic or Co-development PartnerMultiple co-authored publications with Johns Hopkins researchers (Pezhman Foroughi, Alican Demir, Martin Hossbach, Purnima Rajan, etc.) on the LUMENA AR system, MRI-guided interventions, and related technologies. Co-founder Emad Boctor is JHU faculty.

Scale indicators8 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Brainlab: Brainlab offers image-guided surgery and navigation platforms (e.g., Curve, Kick) that overlap directly with Clear Guide's AR instrument-guidance workflow for biopsies and ablations. Comparable specialty breadth across neurosurgery, spine, and interventional radiology makes it the closest navigation-platform direct competitor.
• Philips (PercuNav / Image-Guided Therapy): Philips PercuNav is an ultrasound/CT/MR image-fusion navigation system used for the same biopsies, ablations, and vascular access procedures as Clear Guide SCENERGY. Explicitly benchmarked as a comparable in Clear Guide's own publications; offers integrated sale with Philips ultrasound installed base.
• Medtronic (StealthStation): Medtronic StealthStation is a leading surgical and interventional navigation platform with optical and electromagnetic tracking, serving overlapping hospital departments (neurosurgery, spine, ENT, interventional procedures). Competes for the same hospital capital-equipment budget Clear Guide targets.
• Analogic (BK Medical): BK Medical (an Analogic / now part of GE HealthCare brand) produces premium ultrasound platforms used for image-guided interventions including prostate biopsy and urology — overlapping directly with Clear Guide's transperineal and urology use cases and listed as a validated compatible platform.

Broad incumbents

• GE HealthCare: GE HealthCare offers LOGIQ ultrasound systems with built-in fusion imaging and rigid/EM navigation partnerships. As the manufacturer of the GE Logiq e9 (validated on Clear Guide), GE is both a partner and the most powerful broad incumbent that could bundle navigation natively into its ultrasound platform.
• Siemens Healthineers: Siemens Healthineers offers ACUSON ultrasound with image fusion, plus syngo CT/MR interventional guidance software. As a broad incumbent with full imaging + imaging-guided-therapy portfolio, Siemens competes for the same hospital capital budget and has deeper global sales coverage.
• Stryker (Navigation): Stryker's Navigation division offers optical and electromagnetic surgical navigation systems primarily for orthopedics, spine, ENT, and neurosurgery. Competes for the same hospital capital sales cycles and procedural-navigation budget as Clear Guide, though with a heavier orthopedic focus.
• Hologic: Hologic's Breast & Skeletal Health division offers image-guided biopsy and localization systems for breast procedures with stereotactic and tomosynthesis guidance. Overlaps with Clear Guide's biopsy/ablation use cases in a specific (breast) niche within image-guided intervention.
• Canon Medical Systems: Canon Medical offers diagnostic ultrasound, CT, and MR systems with image-fusion and needle-guidance capabilities. Competes as a broad imaging incumbent with global hospital coverage, particularly strong in Asia-Pacific.

Regional players

• Hitachi (Fujifilm Healthcare): Fujifilm Healthcare (which absorbed Hitachi's diagnostic imaging business) markets ARIETTA ultrasound and interventional imaging systems with real-time fusion and needle navigation. Comparable product overlap with Clear Guide, with particularly strong presence in Asia — a geography Clear Guide does not currently serve.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/channel/UCaR7QuRcE9Jpznq9AVTprSQ
• LinkedInlinkedin.com/company/clear-guide-medical
• Xx.com/clearguide
• Facebookfacebook.com/clearguide

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Funding overview

Funding rounds3 records

Investors2 records

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 Clear Guide Medical