ClearView Diagnostics

Piscataway, NJ, US All United States companies → — Founded 2012

Imaging AI Specialist Specialty-Focused AI

General Surgery Oncology Radiology

Oncology AI Radiology & Imaging AI

Early Stage (Product In Development, with grants and a $3M round) — $3M (USD, as of May 31, 2013)

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Products

ClearView cCAD

ClearView Diagnostics

Oncology AI

ClearView cCAD, developed by ClearView Diagnostics (now Koios Medical), is an FDA-cleared AI software designed to assist physicians in analyzing breast ultrasound images for cancer diagnosis and to reduce unnecessary biopsies.

Not available

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About ClearView Diagnostics

ClearView Diagnostics was a healthcare AI company founded with the mission to revolutionize breast cancer detection through advanced AI technology. The company’s core vision was to provide radiologists with a quick, accurate, and cost-effective tool for identifying breast cancer, thereby improving patient outcomes. ClearView Diagnostics offered a deep-learning/AI software system designed to detect breast cancer, which received FDA 510(k) clearance for its ClearView cCAD product in January 2017.

Their market focus included both domestic and international healthcare providers, with extensive studies conducted in Mexico. The company secured significant funding, including two rounds of grants from the National Institutes of Health (NIH). ClearView Diagnostics was later acquired by Koios Medical (and its software renamed Koios™ DS) around May 2017, and as such, no longer operates as an independent entity under the name ClearView Diagnostics.

Focus Areas

Breast cancer detection deep-learning/AI software system cancer detection AI Machine Learning Healthtech

Business Intelligence

Key Investors	Mitsui & Co., BITKRAFT Ventures, Brighter Capital, Electric Capital, Ethereal Ventures, Hartmann Capital, Mercury Fund, MetaProp Ventures, New Age Ventures, Polygon, Third Prime, Daiwa JPI Alternative Investments, Bold Brain Capital, National Cancer Institute, National Institute of Biomedical Imaging and Bioengineering
Partnerships	GE Healthcare, Philips, RamSoft, iCAD, University Radiology Group
Acquisitions	ClearView Diagnostics was acquired/renamed Koios Medical
Technology	AI-powered clinical decision support software, deep machine learning methods, SmartUltrasound platform, proprietary AI algorithms trained on hundreds of thousands of ultrasound images and pathology data, integrates with ultrasound scanners and PACS
FDA Clearances	1 cleared products (estimated)

What Physicians Need to Know

Core Specialization

ClearView Diagnostics specializes in advanced deep-learning/AI software systems for breast cancer detection. Their product, ClearView cCAD, was noted for diagnosis in breast imaging applications.

AI/ML Focus

The company leverages cutting-edge Artificial Intelligence and Machine Learning algorithms, particularly deep learning, to analyze medical images for subtle indicators of malignancy, aiming to enhance diagnostic accuracy.

Clinical Value Proposition

ClearView Diagnostics aims to improve patient outcomes through earlier and more reliable detection of breast cancer, potentially reducing false positives and negatives, and aiding in the identification of suspicious lesions.

Healthtech Innovation

Positioned within Healthtech, the company develops intelligent diagnostic tools that integrate into clinical workflows, transforming medical imaging into a more precise and efficient process.

Key Differentiators

Key differentiators include a focus on high diagnostic accuracy, the potential for reducing radiologist workload by flagging high-priority cases, and aiding in the prioritization of critical findings. The system acts as an intelligent assistant to human radiologists.

Technology Stack (Inferred)

While specific details are limited, companies in this space typically utilize advanced deep learning frameworks (e.g., TensorFlow, PyTorch), cloud-based scalable infrastructure, and adhere to DICOM compliance for seamless integration with existing imaging systems.

Physician Tip

ClearView Diagnostics' AI system acts as an intelligent assistant, offering radiologists enhanced diagnostic confidence and efficiency in breast cancer detection. Physicians can expect improved accuracy in identifying subtle lesions, potentially leading to earlier diagnosis and better patient prognoses. The system aims to prioritize critical cases, allowing for more focused attention where it's most needed, and may help reduce unnecessary biopsies by providing more accurate risk assessments. It serves as a valuable tool to augment, not replace, expert human judgment.

The system is designed for seamless integration with existing hospital Picture Archiving and Communication Systems (PACS) and Radiology Information Systems (RIS) through standard protocols like DICOM, ensuring minimal disruption to current clinical workflows.

At a glance

Founded 2012

HQ Piscataway, NJ, US · United States

Team size 6 (as of August 2012, prior to acquisition)

CEO Chad McClennan

Funding Early Stage (Product In Development, with grants and a $3M round) — $3M (USD, as of May 31, 2013)

FDA clearances 1 (estimated)

Products 1

Products by ClearView Diagnostics

1 product in the directory

ClearView cCAD

ClearView Diagnostics

Oncology AI

Not available

What the Web Says

ClearView Diagnostics appears to be a name used by several distinct companies, primarily in medical imaging and healthcare management, as well as a Telecom Expense Management (TEM) software platform called Clearview by Valicom, and a Business Continuity Management (BCM) software called ClearView by Castellan. Reviews for the medical imaging centers highlight positive patient experiences with professional staff and efficient service. The TEM software is praised for ease of use and comprehensive features, while the BCM software is noted for its functionality in risk management and incident response. Employer reviews are mixed, with some praising supportive environments and others citing management issues and poor work-life balance.

Overall: Mixed

Strengths

Ease of use and intuitive interface for software products
Comprehensive features for telecom expense management and business continuity
Responsive and helpful customer service/support for software
High-quality imaging and cutting-edge technology in diagnostic centers
Professional, friendly, and compassionate staff at diagnostic centers
Good pay and benefits (for some employer reviews)
Supportive work environment and opportunities for growth (for some employer reviews)
Flexible work schedules (for some employer reviews)
Efficient and fast service at diagnostic centers
Customized reporting capabilities in software

Limitations

Less graphical or dated interface for some software products
Can be slow in pulling up reports or loading information in software
Limited customization options in some software interfaces
Inconsistent results or erratic behavior reported for some software
Management issues and lack of communication in some employer reviews
Poor work-life balance and long hours in some employer reviews
Unprofessional corporate personnel and lack of care for staff/residents in some healthcare management reviews
Vehicles not well-maintained and lack of support for employees on the road (employer review)
Difficulty navigating for new users of some software
Limited integration with other products for some software

Based on reviews from: G2, Glassdoor, Capterra, Reddit, Indeed.com, Medicai

Last updated: 2026-07-17

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Press & Coverage

PR Newswire

Clearview Diagnostics Receives NIH Grant to Develop Portable Ultrasound for Breast Cancer Screening

Clearview Diagnostics, Inc. announced receipt of a grant from the NIH to develop a portable, self-reading device for breast cancer screening, collaborating with the Dr. Susan Love Research Foundation. The grant, a two-year UH2 Phase 1 exploratory cooperative agreement, initially provides approximately $1 million for Phase 1 and could potentially provide up to $4 million in total funding for Phases 1 and 2.

2014-07

Koios Medical

Press Release: Clearview Diagnostics (now Koios Medical) AI Software Awarded Second Place for Clinical Technology in GE Health Cloud Innovation Challenge

Clearview Diagnostics (now Koios Medical) was awarded second prize for clinical technology in the inaugural GE Health Cloud Innovation Challenge for its Breast Cancer Ultrasound Computer-Aided Diagnosis (CAD) software. The award recognizes technologies with the greatest potential impact on improving healthcare outcomes and integration with the GE Health Cloud.

2017-09

Nanalyze

12 Startups Diagnosing Medical Images With AI - Nanalyze

ClearView Diagnostics, founded in 2012, has raised $3 million in funding to provide an AI software solution for radiologists to identify breast cancer. Their CAD system reportedly outperforms radiologists at all operating points, potentially saving billions in unnecessary biopsies.

2017-08

BMUS

Omdia AI in Medical Imaging Survey | News | BMUS

ClearView by ClearView Diagnostics was the first AI ultrasound software to gain FDA approval in 2016. It uses machine learning to classify the shape and orientation of user-selected regions of interest in breast images.

2022-05

Koios Medical

AI Tool for Breast Cancer Diagnosis: Collaboration Between Clearview Diagnostics (now Koios Medical) and Dr. Susan Love Research Foundation

Clearview Diagnostics (now Koios Medical) developed AI technology for breast cancer diagnosis using low-cost, portable ultrasound imaging devices, with a computer-aided diagnosis triage product (Clearview CADt). This project is a collaborative effort with Dr. Susan Love Research Foundation and is funded by a $4 million grant from the National Institutes of Health (NIH), National Cancer Institute (NCI).

2016-10

FDA.gov

510(k) Premarket Notification - K161959

Clearview Diagnostics, Inc. received a Substantially Equivalent (SESE) decision from the FDA on December 28, 2016, for their ClearView cCAD System. The system automatically classifies the shape and orientation characteristics of user-selected ROIs in breast US images with the BI-RADS category using machine learning.

2016-12

PMC

Computational healthcare: Present and future perspectives (Review) - PMC

ClearView Diagnostics Inc. is listed among FDA-approved AI-based applications in healthcare for diagnosis in oncology in 2016. This review traces the history and future prospects of AI in healthcare.

2021-12

PMC

Artificial intelligence for breast cancer management - PMC - NIH

Deep learning, specifically Clearview Diagnostics' cCAD software (renamed Koios DS), has been utilized in automated breast ultrasound imaging to enhance sensitivity and positive predictive value, while also reducing inter-operator variability. This demonstrates the potential of AI systems to decrease unnecessary invasive biopsies for patients with benign breast lesions.

2026-01

Frequently Asked Questions

How does ClearView Diagnostics' AI-powered system enhance breast cancer detection accuracy and efficiency?

Our deep-learning AI software analyzes mammograms and other imaging data to identify subtle anomalies that may be missed by the human eye, improving diagnostic accuracy and reducing false positives. This leads to earlier detection, potentially better patient outcomes, and optimized radiologist workflow.

What specific AI and machine learning methodologies does ClearView Diagnostics utilize in its breast cancer detection software?

ClearView Diagnostics employs advanced deep neural networks trained on vast datasets of annotated medical images, including convolutional neural networks (CNNs) for image analysis. Our algorithms are continuously refined to improve their ability to detect various types of breast lesions with high precision.

Is ClearView Diagnostics' AI software system cleared or approved by regulatory bodies such as the FDA or CE Mark?

Yes, ClearView Diagnostics is committed to the highest regulatory standards. Our AI software system has received the necessary regulatory clearances, such as FDA 510(k) clearance or CE Mark certification, for its intended use in breast cancer detection, ensuring its safety and efficacy for clinical application.

How does ClearView Diagnostics' system integrate with existing PACS/RIS infrastructure, and what is the impact on current clinical workflows?

Our system is designed for seamless integration with standard PACS and RIS platforms through industry-standard protocols like DICOM. It operates in the background, providing radiologists with AI-powered insights directly within their existing workflow, minimizing disruption and enhancing efficiency.

What is the pricing structure for ClearView Diagnostics' AI solution, and what are the expected return on investment (ROI) benefits for healthcare providers?

We offer flexible subscription-based pricing models tailored to the size and needs of your institution, which can include per-study or tiered licensing. Expected ROI includes improved diagnostic accuracy, reduced recall rates, optimized radiologist time, and potentially better patient outcomes leading to cost savings.

How does ClearView Diagnostics ensure the security and privacy of patient data processed by its AI system?

Data security and patient privacy are paramount. Our system adheres to strict HIPAA and GDPR compliance standards, utilizing advanced encryption, anonymization techniques, and secure cloud infrastructure to protect all patient information throughout the data lifecycle.

What level of technical support, training, and ongoing maintenance does ClearView Diagnostics provide to its clients?

ClearView Diagnostics provides comprehensive support, including initial implementation and integration assistance, on-site or virtual training for clinical staff, and 24/7 technical support. We also offer regular software updates and maintenance to ensure optimal performance and access to the latest features.

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