Bionime upholds the company’s ‘6σ DNA Corporate Culture’
and continuously strives for excellence.
Founded in 2003, Bionime faced the international safety standards adopted by the FDA & CE under ISO15197, which defined the accuracy specification for “Self-Monitoring Blood Glucose (SMBG) meters” as ±20%. This was questioned by the American Diabetes Association (ADA), which requested that the accuracy be increased to ±5% to ensure patient safety. However, the FDA responded with “No company could meet that standard with current technology.” In response, Bionime set a goal of achieving ±10% accuracy for their SMBG product to meet user safety needs and established the company vision of “Better Blood Glucose Control, Healthier Life.”
The German third-party organization IDT conducted multiple accuracy tests on blood glucose meters available in the market and published their reports at the ADA annual meeting in the U.S. and the EASD annual meeting in Europe. Bionime’s BGM was ranked first in accuracy among more than twenty international brand glucose meters tested. The report showed that Bionime’s BGM achieved an accuracy of ±10%, making it one of the international Top-3 BGMs*, fulfilling the goal set by Bionime when it was founded. However, due to the nature of “lancing blood glucose meters,” they can only provide “single-point blood glucose data,” and there are “monitoring blind spots” when not in use. Patients may only realize they are at risk after experiencing hypoglycemia. Therefore, even with ±10% accuracy, BGM cannot fully ensure user safety. As a result, Bionime fully invested in the development of the CGM in 2016.
* References
Freckmann, G., Baumstark, A., Pleus, S., Schlüter, D. K., & Heinemann, L. (2019). System accuracy evaluation of 18 CE-marked current-generation blood glucose monitoring systems based on EN ISO 15197:2015. BMJ Open Diabetes Research and Care, 7(1), e000613.
CGM, unlike traditional BGM blood glucose meters, is worn on the upper arm. The CGM sensor’s “glucose oxidase micro-needle” is inserted 0.5 cm under the skin and can continuously monitor for 7 to 15 days. It measures the glucose concentration in the interstitial fluid (ISF) of subcutaneous cells and transmits a glucose reading every minute to a smartphone CGM app. The app generates a continuous “dynamic blood glucose fluctuation curve”,providing users with a clear and easy-to-understand overview of their blood glucose levels for real-time and uninterrupted monitoring.
The CGM app can also be preset to issue alerts before reaching “high/low-risk blood glucose” levels, enabling users and caregivers to take timely action and prevent life-threatening complications caused by dangerous blood glucose fluctuations.
CGM is not only the “most powerful tool for blood glucose monitoring” but also an “essential indicator of lifestyle.”
A commitment to delivering precise, high-quality,
and user-friendly blood glucose management tools to our customers.
Starting with the end in mind, Bionime provides highly accurate blood glucose monitoring devices and leverages IoT technology to create a “human-centered” blood glucose management ecosystem. This ecosystem includes a self-monitoring blood glucose management app, the Rightest CARE app for caregivers, the professional medical Diabetes Management System (DMS), as well as customer service and marketing systems. Together, these elements deliver a comprehensive digital blood glucose management solution to the market.
Human-Centered
Create a “human-centered” blood
glucose management ecosystem
by building a cloud-based blood
glucose management system
platform under the self-owned
brand “RIGHTEST” with an IoT
digital solution framework. This
system integrates “medical data
from the product side” and “customer service and marketing data from the market side”, merging remote data from both online and offline sources into “real-time information”.
Through a user-friendly mobile
app interface, it provides clear
and actionable insights, helping
users improve their lifestyle more
accurately, efficiently, and quickly,
embracing a comfortable life.
Strive for Excellence
The international third-party
organization IDT has conducted
multiple accuracy tests on blood
glucose meters (BGM) on the
market and performed clinical tests
in German hospitals. Bionime’s
RIGHTEST BGM was ranked #1 in
accuracy and proudly ranked among
the global Top-3, achieving an
exceptional accuracy of ±10%.
Social Responsibility
Embracing the ESG (Environmental, Social, and Governance) corporate social responsibility concept, Bionime has chosen to develop the more technically advanced rechargeable CGM product.The transmitter features a patented, energy-efficient design that incorporates Bluetooth transmission technology and is both rechargeable and reusable, with a 5-year warranty.
This significantly reduces the consumption of consumables over the years of CGM use, cutting waste by eliminating the need for 180 Bluetooth ICRs, 180 batteries, 180 PCBs, plastic casings, and more over 5 years.
Hand in Hand,
Creating Value Together
In October 2023, the “RIGHTEST iFree Continuous Glucose Monitoring System” became the first product to receive the CGM medical device manufacturing license from the Taiwan Ministry of Health and Welfare. In 2023, the global market value of CGM surpassed that of traditional BGM products, reaching over 10 billion USD. The blood glucose monitoring product market has undergone an irreversible paradigm shift, and it is projected that the global market value of CGM will be 4 to 5 times that of BGM in the future.
Since 2016, Bionime has been dedicated to the research and development of CGM products. It has applied for over 400 international patents, with more than 200 national patent certificates granted, ranking fifth globally in the number of patent certifications for CGM. Bionime has also commissioned four top U.S. patent firms, three European firms, and one Asian firm to conduct a global patent infringement analysis to determine whether Bionime’s CGM products infringe on patents held by other CGM competitors. All reports have shown low-risk Freedom to Operate (FTO), which is essential for entering the international CGM market. Bionime holds a unique competitive advantage in patent R&D technology and manufacturing capabilities, and looks forward to inviting more market partners to cooperate and create value together.
Innovation in DNA, Commitment to Quality in Our Mission
Bionime, to better connect with local markets, has established subsidiaries across four continents and is actively cultivating a network of distributors from nearly 100 countries worldwide, working together to manage the global market.
Rooted Locally, Aiming Globally
Bionime, to better connect with local markets, has established subsidiaries across four continents and is actively cultivating a network of distributors from nearly 100 countries worldwide, working together to manage the global market.
Bionime upholds the company’s ‘6σ DNA Corporate Culture’
and continuously strives for excellence.
Founded in 2003, Bionime faced the international safety standards adopted by the FDA & CE under ISO15197, which defined the accuracy specification for “Self-Monitoring Blood Glucose (SMBG) meters” as ±20%. This was questioned by the American Diabetes Association (ADA), which requested that the accuracy be increased to ±5% to ensure patient safety. However, the FDA responded with “No company could meet that standard with current technology.” In response, Bionime set a goal of achieving ±10% accuracy for their SMBG product to meet user safety needs and established the company vision of “Better Blood Glucose Control, Healthier Life.”
The German third-party organization IDT conducted multiple accuracy tests on blood glucose meters available in the market and published their reports at the ADA annual meeting in the U.S. and the EASD annual meeting in Europe. Bionime’s BGM was ranked first in accuracy among more than twenty international brand glucose meters tested. The report showed that Bionime’s BGM achieved an accuracy of ±10%, making it one of the international Top-3 BGMs*, fulfilling the goal set by Bionime when it was founded. However, due to the nature of “lancing blood glucose meters,” they can only provide “single-point blood glucose data,” and there are “monitoring blind spots” when not in use. Patients may only realize they are at risk after experiencing hypoglycemia. Therefore, even with ±10% accuracy, BGM cannot fully ensure user safety. As a result, Bionime fully invested in the development of the CGM in 2016.
* References
Freckmann, G., Baumstark, A., Pleus, S., Schlüter, D. K., & Heinemann, L. (2019). System accuracy evaluation of 18 CE-marked current-generation blood glucose monitoring systems based on EN ISO 15197:2015. BMJ Open Diabetes Research and Care, 7(1), e000613.
CGM, unlike traditional BGM blood glucose meters, is worn on the upper arm. The CGM sensor’s “glucose oxidase micro-needle” is inserted 0.5 cm under the skin and can continuously monitor for 7 to 15 days. It measures the glucose concentration in the interstitial fluid (ISF) of subcutaneous cells and transmits a glucose reading every minute to a smartphone CGM app. The app generates a continuous “dynamic blood glucose fluctuation curve”,providing users with a clear and easy-to-understand overview of their blood glucose levels for real-time and uninterrupted monitoring.
The CGM app can also be preset to issue alerts before reaching “high/low-risk blood glucose” levels, enabling users and caregivers to take timely action and prevent life-threatening complications caused by dangerous blood glucose fluctuations.
CGM is not only the “most powerful tool for blood glucose monitoring” but also an “essential indicator of lifestyle.”
A commitment to delivering precise, high-quality,
and user-friendly blood glucose management tools to our customers.
Starting with the end in mind, Bionime provides highly accurate blood glucose monitoring devices and leverages IoT technology to create a “human-centered” blood glucose management ecosystem. This ecosystem includes a self-monitoring blood glucose management app, the Rightest CARE app for caregivers, the professional medical Diabetes Management System (DMS), as well as customer service and marketing systems. Together, these elements deliver a comprehensive digital blood glucose management solution to the market.
Human-Centered
Create a “human-centered” blood
glucose management ecosystem
by building a cloud-based blood
glucose management system
platform under the self-owned
brand “RIGHTEST” with an IoT
digital solution framework. This
system integrates “medical data
from the product side” and “customer service and marketing data from the market side”, merging remote data from both online and offline sources into “real-time information”. Through a user-friendly mobile app interface, it provides clear
and actionable insights, helping
users improve their lifestyle more
accurately, efficiently, and quickly,
embracing a comfortable life.
Strive for Excellence
The international third-party organization IDT has conducted
multiple accuracy tests on blood
glucose meters (BGM) on the
market and performed clinical tests in German hospitals. Bionime’s RIGHTEST BGM was ranked #1 in accuracy and proudly ranked among the global Top-3, achieving an exceptional accuracy of ±10%.
Social Responsibility
Embracing the ESG (Environmental, Social, and Governance) corporate social responsibility concept, Bionime has chosen to develop the more technically advanced rechargeable CGM product.The transmitter features a patented, energy-efficient design that incorporates Bluetooth transmission technology and is both rechargeable and reusable, with a 5-year warranty.
This significantly reduces the consumption of consumables over the years of CGM use, cutting waste by eliminating the need for 180 Bluetooth ICRs, 180 batteries, 180 PCBs, plastic casings, and more over 5 years.
BETTER HEALTH
FOR MORE PEOPLE
Hand in Hand,
Creating Value Together
In October 2023, the “RIGHTEST iFree Continuous Glucose Monitoring System” became the first product to receive the CGM medical device manufacturing license from the Taiwan Ministry of Health and Welfare. In 2023, the global market value of CGM surpassed that of traditional BGM products, reaching over 10 billion USD. The blood glucose monitoring product market has undergone an irreversible paradigm shift, and it is projected that the global market value of CGM will be 4 to 5 times that of BGM in the future.
Since 2016, Bionime has been dedicated to the research and development of CGM products. It has applied for over 400 international patents, with more than 200 national patent certificates granted, ranking fifth globally in the number of patent certifications for CGM. Bionime has also commissioned four top U.S. patent firms, three European firms, and one Asian firm to conduct a global patent infringement analysis to determine whether Bionime’s CGM products infringe on patents held by other CGM competitors. All reports have shown low-risk Freedom to Operate (FTO), which is essential for entering the international CGM market. Bionime holds a unique competitive advantage in patent R&D technology and manufacturing capabilities, and looks forward to inviting more market partners to cooperate and create value together.
Innovation in DNA, Commitment to Quality in Our Mission
Bionime, to better connect with local markets, has established subsidiaries across four continents and is actively cultivating a network of distributors from nearly 100 countries worldwide, working together to manage the global market.
Rooted Locally,
Aiming Globally
Bionime, to better connect with local markets, has established subsidiaries across four continents and is actively cultivating a network of distributors from nearly 100 countries worldwide, working together to manage the global market.
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Description
Bionime Corporation │ Customer Service Hotline 0800-371-688 │ Service Hours: Monday to Friday 8:30-22:00
