Boston Medical Sciences' AIM4CRC Designated as U.S. FDA Breakthrough Device ~Accelerating Commercialization in the U.S. Market and Global Expansion with Stool-Free Virtual Colonoscopy™ AI Technology~
Boston Medical Sciences' AI-powered "stool-free virtual colonoscopy™ examination system AIM4CRC" has been designated as a Breakthrough Device by the U.S. FDA. This will reduce patient burden in colorectal cancer screening and accelerate its commercialization in the US market.
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- 📰 Published: May 14, 2026 at 18:00
- 🔍 Collected: May 14, 2026 at 09:32
- 🤖 AI Analyzed: May 14, 2026 at 09:34 (2 min after Collected)
Boston Medical Sciences Co., Ltd. (Headquarters: Chuo-ku, Tokyo; Representative Director CEO: Masaki Okamoto; hereinafter "the Company") is pleased to announce that its stool-free virtual colonoscopy™ examination system "AIM4CRC," developed by the Company, has been accepted into the U.S. Food and Drug Administration's (FDA) Breakthrough Devices Program and has been designated as a Breakthrough Device.
This designation is a system granted by the FDA to medical devices that have the potential to provide a significant clinical improvement compared to existing technologies for serious conditions. AIM4CRC was evaluated as "Computer-Assisted Detection (CADe) software that assists in the detection of colorectal polyps in colon CT images taken under stool-free conditions" and received the Breakthrough Device Designation.
Colorectal cancer is one of the leading causes of cancer deaths worldwide, yet screening rates remain a challenge due to the physical and psychological burden associated with detailed examinations. The Company aims to realize "stool-free virtual colonoscopy™ examination" utilizing AI technology, and is advancing the construction of new medical infrastructure that contributes to the early detection and prevention of colorectal cancer while significantly reducing patient burden.
With this designation, the Company will accelerate its development and regulatory compliance for the U.S. market, receiving priority communication and development support from the FDA. While this designation does not guarantee future clearance, we believe it reflects the FDA's evaluation of the clinical importance of this technology and its potential to address unmet medical needs.
## Comment from Masaki Okamoto, Representative Director CEO of Boston Medical Sciences Co., Ltd.
"Following the designation in 2024 by the Ministry of Health, Labour and Welfare as a 'priority review item for program medical devices,' I am deeply honored that AIM4CRC has now been designated as a 'Breakthrough Device' by the FDA. I interpret this designation not merely as an AI image analysis technology, but as a technology that could fundamentally transform the accessibility of colorectal cancer screening itself. We will provide a new option to many people who avoid examinations due to the burden of purgatives. Moving forward, we aim to realize medical infrastructure that is valuable to both patients and medical professionals in the global market, including the United States."
## About the Breakthrough Devices Program
The Breakthrough Devices Program is an FDA initiative that provides priority support for medical devices that have the potential to provide more effective diagnosis or treatment for life-threatening or irreversibly debilitating diseases. Medical devices that receive this designation can proceed with an efficient development and review process through early and continuous dialogue with the FDA.
## About Boston Medical Sciences Co., Ltd.
Boston Medical Sciences Co., Ltd. is a medical tech startup that conducts research and development of AI-powered next-generation colorectal CT examination technology, with the slogan "Towards a world where no one dies from colorectal cancer." By integrating core technologies such as virtual bowel preparation AI, colorectal polyp detection AI, and image reconstruction technology, the company aims to achieve "stool-free virtual colonoscopy™ examination."
## Company Overview
- Headquarters: 3F B-PORT, Nihonbashi Honcho Showa Dori Bldg., 3-7-2 Nihonbashi Honcho, Chuo-ku, Tokyo
- R&D Center: 6F, R.core Nihonbashi Ningyocho Bldg., 7-13 Nihonbashi Tomizawa-cho, Chuo-ku, Tokyo (BMS Research)
- Established: April 2023
- Founder & Representative: Masaki Okamoto
- Main Business: Research, development, and clinical implementation of non-invasive colorectal cancer screening AI systems
- URL: https://b-ms.tech
*This press release is intended to provide information regarding the progress of our research and development and business development, and is not intended for the purpose of promoting sales or advertising specific medical devices.
* "AIM4CRC" mentioned in this document is currently an unapproved medical device in Japan and the United States, and cannot be sold or distributed.
This designation is a system granted by the FDA to medical devices that have the potential to provide a significant clinical improvement compared to existing technologies for serious conditions. AIM4CRC was evaluated as "Computer-Assisted Detection (CADe) software that assists in the detection of colorectal polyps in colon CT images taken under stool-free conditions" and received the Breakthrough Device Designation.
Colorectal cancer is one of the leading causes of cancer deaths worldwide, yet screening rates remain a challenge due to the physical and psychological burden associated with detailed examinations. The Company aims to realize "stool-free virtual colonoscopy™ examination" utilizing AI technology, and is advancing the construction of new medical infrastructure that contributes to the early detection and prevention of colorectal cancer while significantly reducing patient burden.
With this designation, the Company will accelerate its development and regulatory compliance for the U.S. market, receiving priority communication and development support from the FDA. While this designation does not guarantee future clearance, we believe it reflects the FDA's evaluation of the clinical importance of this technology and its potential to address unmet medical needs.
## Comment from Masaki Okamoto, Representative Director CEO of Boston Medical Sciences Co., Ltd.
"Following the designation in 2024 by the Ministry of Health, Labour and Welfare as a 'priority review item for program medical devices,' I am deeply honored that AIM4CRC has now been designated as a 'Breakthrough Device' by the FDA. I interpret this designation not merely as an AI image analysis technology, but as a technology that could fundamentally transform the accessibility of colorectal cancer screening itself. We will provide a new option to many people who avoid examinations due to the burden of purgatives. Moving forward, we aim to realize medical infrastructure that is valuable to both patients and medical professionals in the global market, including the United States."
## About the Breakthrough Devices Program
The Breakthrough Devices Program is an FDA initiative that provides priority support for medical devices that have the potential to provide more effective diagnosis or treatment for life-threatening or irreversibly debilitating diseases. Medical devices that receive this designation can proceed with an efficient development and review process through early and continuous dialogue with the FDA.
## About Boston Medical Sciences Co., Ltd.
Boston Medical Sciences Co., Ltd. is a medical tech startup that conducts research and development of AI-powered next-generation colorectal CT examination technology, with the slogan "Towards a world where no one dies from colorectal cancer." By integrating core technologies such as virtual bowel preparation AI, colorectal polyp detection AI, and image reconstruction technology, the company aims to achieve "stool-free virtual colonoscopy™ examination."
## Company Overview
- Headquarters: 3F B-PORT, Nihonbashi Honcho Showa Dori Bldg., 3-7-2 Nihonbashi Honcho, Chuo-ku, Tokyo
- R&D Center: 6F, R.core Nihonbashi Ningyocho Bldg., 7-13 Nihonbashi Tomizawa-cho, Chuo-ku, Tokyo (BMS Research)
- Established: April 2023
- Founder & Representative: Masaki Okamoto
- Main Business: Research, development, and clinical implementation of non-invasive colorectal cancer screening AI systems
- URL: https://b-ms.tech
*This press release is intended to provide information regarding the progress of our research and development and business development, and is not intended for the purpose of promoting sales or advertising specific medical devices.
* "AIM4CRC" mentioned in this document is currently an unapproved medical device in Japan and the United States, and cannot be sold or distributed.