Barreleye, a global leader in quantitative ultrasound solutions, is redefining the boundaries of ultrasound imaging through its original AI-powered technology developed at KAIST. By enabling ultrasound to deliver objective, high-resolution diagnostic information comparable to CT and MRI—while retaining ultrasound’s inherent safety and cost-efficiency—the company is opening a new frontier in medical diagnostics.

Recently, Barreleye received Class III medical device approval from the Ministry of Food and Drug Safety (MFDS) for its AI-based breast tumor diagnosis software Vis-BUS, validating both the safety and clinical usefulness of its technology and increasing industry-wide attention toward quantitative ultrasound.

Breakthrough Technology: Restoring Lost Ultrasound Information

Traditional ultrasound produces visual images of organs and lesions but loses substantial raw waveform information during the image reconstruction process, limiting accuracy and objectivity.
Barreleye’s core innovation lies in quantitatively analyzing the ultrasound signal itself to extract biomechanical tissue properties, including:

• Tissue density
• Elasticity
• Fat content
• Acoustic attenuation behavior

Through AI algorithms, these quantitative tissue parameters are converted into intuitive diagnostic maps, enabling objective risk assessment and automated lesion characterization.
The technology integrates seamlessly into existing ultrasound workflows—requiring only software installation, not new hardware—enabling immediate scalability across clinical environments.

Barreleye is building a specialized product lineup across breast, liver, lung, thyroid, and cardiac diseases, each designed to provide lesion features and risk scores directly from ultrasound scans.

Clinical and Industry Value Across Stakeholder Groups

Hospitals and Clinicians
Vis-BUS automatically detects suspicious lesions and provides numerical malignancy likelihood, improving diagnostic accuracy while reducing interpretation time. Real-time diagnostic metadata enables physicians to determine optimal treatment plans without relying on additional imaging. Seamless compatibility with existing ultrasound devices lowers operational cost while improving clinical efficiency.

Patients
Patients benefit from high-precision, radiation-free diagnostics at lower cost and with shorter exam duration. Earlier disease detection reduces unnecessary biopsies and supports better long-term outcomes with lower financial and psychological burden.

Researchers
Quantified ultrasound biomarkers provide valuable resources for research and clinical trials. Objective measurements enable monitoring of disease progression, biomarker discovery, and development of new AI-based diagnostic models.

Investors
The global ultrasound market—valued at approximately USD 9B in 2023 and expected to exceed USD 14B by 2030—continues to grow rapidly. With world-first technology, a high entry barrier, and demonstrated commercial traction (including MFDS approval), Barreleye is positioned as a high-growth deep-tech company in the medical AI sector.

Future Outlook and Global Expansion

Barreleye’s long-term strategy is to accelerate the convergence of AI and ultrasound physics to make ultrasound a single, definitive diagnostic modality for most diseases. To achieve this, the company is:

• Expanding global clinical partnerships to strengthen algorithm performance with diverse datasets
• Extending product lines beyond breast, liver, and cardiac applications into additional disease areas 
• Advancing regulatory approvals, including FDA and CE certification pathways 
• Establishing commercial footholds in North America and Europe through exhibitions and networking (RSNA, VivaTech, CES 2024)

Under the vision “Beyond Ultrasound: Seeing the Unseen,” Barreleye aims not only to commercialize innovative diagnostic software but also to reduce worldwide healthcare disparities and redefine the role of ultrasound in modern medicine.
The company’s ultimate objective is to establish quantitative ultrasound as a new global standard in medical diagnostics over the next five years.

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