Barreleye Inc.’s breast cancer diagnostic support software, Int-BUS(Intelligent BUS), has been officially designated as an Innovative Medical Device.

Intelligent BUS is the world’s first quantitative ultrasound imaging technology for breast cancer diagnosis support. It utilizes data extracted directly from existing ultrasound systems without requiring hardware modifications, reconstructing biomechanical tissue properties quantitatively to deliver richer and more precise diagnostic information to clinicians.

Innovative Medical Devices are defined as medical technologies that demonstrate—or are expected to demonstrate—significant improvement in safety and effectiveness compared with existing technologies or treatment modalities. The designation provides regulatory benefits such as expedited review pathways and prioritized evaluation, as well as preferential access to government support programs.

Hyeon-Min Bae, CEO of Barreleye, stated:

“Intelligent BUS presents a new type of quantitative ultrasound imaging that enables assessment of tumor biomechanical properties using data extracted from a single ultrasound probe. By reducing unnecessary invasive biopsies, we aim to reduce both social costs and the psychological burden on patients. With this designation, we will accelerate confirmatory clinical validation in Korea and abroad.”

Founded in 2021 as a KAIST spin-off, Barreleye develops AI-powered medical software based on quantitative ultrasound technology. The company will showcase its quantitative ultrasound imaging solutions at CES 2024 in Las Vegas starting January 9.

[Source] 조선비즈

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