Medicare Coverage Significantly Expanded for the Eversense E3 CGM System

The decision is further recognition of Eversense as an important option for people with diabetes.

12 February 2024, Parsippany, United States - Ascensia Diabetes Care, a global diabetes care company, and Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, announced that Medicare has significantly expanded access to the Eversense E3 CGM System, the longest lasting CGM available, with the implementation of Local Coverage Determinations providing access to implantable CGM for basal only patients, by the first three Medicare Administrative Contractors (MACs).

Medicare coverage has been expanded for implantable CGMs to include all people with diabetes using insulin, removing the previous requirement for multiple insulin administrations per day. The new policy has also been updated to cover non-insulin-users who have a history of problematic hypoglycemia. Noridian, Palmetto and National Government Services (NGS) are the first three MACs to publish final local coverage determinations (LCD). The earliest MAC expansion becomes effective on February 25, 2024 and the companies expect the remaining MACs to finalize their expansion in the near future.

“We welcome this policy change and look forward to bringing this differentiated CGM option to millions of more Americans through Medicare,” said Rudy Thoms, VP, CGM Commercial US of Ascensia Diabetes Care, a subsidiary of PHC Holdings Corporation (TSE 6523). “Eversense E3 is a truly unique technology and optionality is key in diabetes care, where what works for one person does not always work for all. In particular, our Medicare users love that this twice-yearly CGM offers them unparalleled reliability and flexibility, without the burden of regular self-insertions and the constant reordering of supplies. It is important that people with diabetes have the same access to the benefits of a fully implantable, long-term CGM, as they do to traditional CGMs [that have a much shorter lifespan], and so we are thrilled to see this expansion.”... Ascensia Diabetes Care's Press Release - Senseonics' Press Release -

Bayer closes on divestiture of Diabetes Care business to Panasonic Healthcare Holdings Co., Ltd. for around EUR 1 billion

Transaction includes blood glucose monitoring systems and lancing devices for people with diabetes 

January 5, 2016 – Bayer AG closed on its previously announced agreement to sell its Diabetes Care business to Panasonic Healthcare Holdings Co., Ltd., a company which is backed by funds sponsored by leading global investment firm KKR and the Panasonic Corporation. The total consideration for the transaction is around EUR 1 billion (JPY 132 billion). The new stand-alone Diabetes Care business is named Ascensia Diabetes Care Holdings and is headquartered in Basel, Switzerland.

The sale includes the leading Contour™ portfolio of blood glucose monitoring meters and strips, as well as other products such as Breeze™2, Elite™ and Microlet™ lancing devices. Bayer’s Diabetes Care business accounted for EUR 909 million in sales in 2014... Bayer's Press Release - Panasonic Healthcare's Press Release

Roche : clearance from the U.S. Food and Drug Administration for the new ACCU-CHEK® Nano SmartView blood glucose monitoring system

01.11.2012 - Innovative, small, no code device will be available to people with diabetes in the U.S. in first half of 2012  

Roche announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its ACCU-CHEK® Nano SmartView blood glucose monitoring system.The new ACCU-CHEK Nano meter, which is smaller than a standard credit card, employs a large brilliant backlit display and does not require any manual coding or code key for enhanced ease of use. It also offers improved functions such as customizable test reminders, pre- and postmeal markers and average glucose calculation. The ACCU-CHEK Nano meter uses ACCU-CHEK® SmartView test strips and will be available to customers in the first half of 2012.

“We are very excited to bring this latest blood glucose monitoring technology to the United States,” said Luc Vierstraete, Global Head of Roche Diabetes Care. “The ACCU-CHEK Nano meter is the newest advancement in Roche’s more than 35-year commitment to bring state-of-the-art innovations to people with diabetes and their caregivers, and continues our promise to enabling optimal diabetes management. This new system will help us to further leverage and enhance our position in this important market.”... Roche's Press Release -

Eisai and EIDIA : Launch of LIFE CHECK, a Self-monitoring Blood Glucose Meter That is Easy for Elderly Diabetes Patients to Use

January 19, 2012 - Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) and its diagnostics subsidiary EIDIA Co., Ltd. (Headquarters: Tokyo, President & CEO: Keisuke Watanabe, “EIDIA”) announced that EIDIA will launch LIFE CHECK, a self-monitoring blood glucose meter manufactured by Gunze Limited (Headquarters: Osaka, President & CEO: Hiroshi Hirata, “Gunze”), on January 27, 2012.

LIFE CHECK is a personal self-monitoring blood glucose meter with which diabetes patients can monitor their own blood glucose level by simply inserting a dedicated sensor known as the LIFE CHECK SENSOR into the meter. The meter was developed as a next-generation model of the blood glucose monitor G-CHECK currently manufactured by Gunze and marketed by EIDIA. While Gunze received approval to manufacture and market LIFE CHECK in August 2011, the system will be distributed and marketed by EIDIA and co-promoted by Eisai.

The LIFE CHECK meter employs a color liquid crystal screen that displays step-by-step operational instructions and easy-to-read graphs of measured data. After measurement, the dedicated sensor can be easily and safely removed from the meter with the push of a button without the patient having to touch the part to which their blood has been applied... Eisai's Press Release -

GE Selects Bionime to Launch Innovative Diabetes Solutions

17 January 2012 - Bionime will offer innovative GE-branded clinical and home-based patient care products for the rapidly growing global diabetes population -

GE (NYSE: GE) announced it has entered into a new worldwide licensing agreement with Bionime, a global leader in biotechnology medical testing, to provide new GE-branded solutions for the diabetes market.

According to the World Health Organization, an estimated 346 million people worldwide have diabetes. Type 2 diabetes is the fastest growing chronic disease in the world. Through this agreement, Bionime will deliver GE-branded blood glucose monitors, test strips, kits and related diabetes accessories.



The first product to be launched is the GE100 Blood Glucose Monitoring System, available now through durable medical equipment suppliers and on retail shelves in 2012. The GE100 utilizes advanced patented strip technology to achieve a high level of accuracy and precision and a unique, innovative strip design that makes it easier to use and more sanitary for the consumer than current similar offerings. In addition, patented True Auto Coding Technology eliminates the need to code each strip lot without sacrificing the accuracy of the readings. The GE100 provides an easy, clean and accurate way to test blood glucose levels of people living with diabetes... GE Healthcare's Press Release - Bionime's Press Release -

Grove Instruments : Noninvasive Glucose Monitor

September 2011 –  Grove has received $998K for an SBIR Phase II grant titled “Development of a Fiberless Transflectance Noninvasive Glucose Monitor” from the NIDDK NIH... Grove Instruments' news -

About Grove Instruments

Grove Instruments,Inc. is a privately held pre-market medical device company developing the world's first noninvasive glucometer with the potential to exceed the ISO standard for blood glucose meters.

Grove's patented technology is based on the seminal concept of the Optical Bridge and is unique among all NIR spectroscopic approaches to noninvasive blood glucose determination.

The Company has been recognized for its innovation, technology development and clinical results on 10 separate occasions by the NIH NIDDK with funded SBIR Grants.

In 2011, Grove was also recognized by the Massachusetts Life Sciences Center with an Accelerator Award – one of only 4 recipients out of all Boston-area life sciences companies applying in that round. [About Grove Instruments]

Telcare : First-in-class mHealth Connected Glucose Meter Cleared by FDA

August 03, 2011 - Telcare, Inc., an exhibitor at this year’s annual meeting of the American Association of Diabetes Educators, has just received clearance from the US Food and Drug Administration to market the Telcare BGM, the first cellular-enabled glucose meter, combined with an FDA-cleared database (Telserve) to aid in the management of diabetes. The device allows patients to transmit their blood glucose readings to caregivers and family members, and receive immediate coaching and clinical feedback relayed to the screen of the glucose meter. The patient does not have to take any additional steps to transmit the data and the cost of the wireless connectivity is included in the price of the device and its accompanying test strips. Thus, users will have a much richer clinical experience at no additional cost when compared to standard glucose meters.
Telcare’s objective is to transform the management of diabetes, from a condition where patients feel cut off from their caregivers and don’t know what to do from day to day, to a model in which the patient is continually empowered to manage his or her condition through continual feedback from caregivers, family members, and even other patients.
The Telcare glucose meter aims to bridge the last mile between patient and caregiver. Real time information is transmitted to the electronic medical record, personal health records, such as Microsoft HealthVault, and a variety of smartphone apps designed to connect patients to family members and to each other. While other marketplace solutions have relied on Bluetooth transmission to cellphones, connections of glucose meters to personal computers and cradles, or requiring the patient to manually enter results into a phone app, Telcare’s solution requires no additional steps on the part of the patient... Telcare’s Press Release -

Echo Therapeutics : Symphony tCGM Demonstration Video

Aug. 9, 2011 - Echo Therapeutics, Inc. (Nasdaq: ECTE), a company developing the Symphony™ tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) system and the Prelude™ SkinPrep System for transdermal drug delivery, announced the unveiling of a much anticipated demonstration video on the Company's website. The new video showcases the features and ease of use of the Symphony continuous glucose monitoring system in a home setting. The Company has released this demonstration video as a result of increasing demands from patients and investors for information regarding how the Symphony tCGM System works.

The launch of the video coincides with the final steps in the planning and preparation of the upcoming clinical study testing the next generation Symphony tCGM System design, which will commence in the near-term... Echo Therapeutics' Press Release -

Sanofi-aventis : innovative blood glucose monitoring self-management of diabetes devices to enhance

September 21, 2010 - Patient-centric approach and new mobile health technology – Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced the upcoming launch of the blood glucose monitoring (BGM) devices BGStar® and iBGStarTM, developed by sanofi-aventis and its partner AgaMatrix. Due to their convenience, accuracy and ease-of-use, BGStar® and iBGStar[TM] will help the decision-making process for people with diabetes and their healthcare professionals, with the aim of improving patient self-management. iBGStarTM connects to the iPhone® or iPod touch®. This is an important step towards sanofi-aventis’ vision of becoming the leader in global diabetes care by integrating innovative monitoring technology, therapeutic innovations, personalized services and support solutions.

BGStar® and iBGStar™ are planned to be made commercially available in the first markets in early 2011.
“Our patient-centric approach means we truly understand the challenges faced by people with diabetes,”... [PDF] Sanofi-aventis' Press Release -

Home Diagnostics and Nipro Diabetes Systems : Plans to Merge to Become Nipro Diagnostics

June 9, 2010 –– Home Diagnostics, Inc. and Nipro Diabetes Systems, Inc. announced that the two companies will merge to become Nipro Diagnostics, Inc. Both companies are wholly-owned by Nipro Corporation, a multi-billion dollar company headquartered in Osaka, Japan and a world leader in providing medical products to the healthcare community.
Home Diagnostics, Inc., based in Fort Lauderdale, Florida, manufactures and markets the TRUE brand of quality, high-performance blood glucose monitoring systems. Home Diagnostics is the co-brand supplier of blood glucose monitoring systems for leading national retail pharmacies, pharmacy wholesalers, medical products distributors and mail-order suppliers. Nipro Diabetes Systems, located in Miramar, Florida, is the manufacturer and marketer of the Amigo® Insulin Pump.
The merger of the two companies results in a comprehensive diabetes monitoring and insulin management product portfolio, which few companies offer. This portfolio will help to ensure that patients and their healthcare professionals have easy access to the high-quality diabetes monitoring and management tools they need to improve quality of life... [PDF] Nipro Diagnostics Press Release -

LifeScan Canada collaborates with country's first consumer ehealth service

May 31, 2010 - LifeScan Canada Ltd. announced a collaboration with Canada's first consumer ehealth service. LifeScan will be the first distributor supporting the diabetes arm of the TELUS health space™ platform, allowing its customers to track all information related to their diabetes and easily share it with any doctor or other healthcare provider they want over a secure Internet connection.

"As a leader in blood glucose monitoring, we are constantly working to improve the lives of Canadians living with diabetes by bringing patients and healthcare providers the next level in diabetes care... LifeScan's Press Release [JNJ] - TELUS health space's Press Release -

Home Diagnostics, Inc. and Cellnovo : Strategic Alliance

May 6, 2010 – Building on a shared vision to simplify diabetes management worldwide, Cellnovo, a London-based medical device company, and Home Diagnostics, Inc., a leader in diabetes products, announced a strategic alliance that involves integrating technologies and developing distribution opportunities for Cellnovo’s insulin patch pumps.

The partnership allows both companies to accelerate their growth and has the potential to transform the pump industry. The first phase of the agreement calls for the inclusion of Home Diagnostics TRUE™ blood glucose technology in the Cellnovo wireless mobile handset. The companies will also begin exploring ways to leverage Home Diagnostics’ distribution network to expand Cellnovo’s presence in the United States and other countries... [PDF] Home Diagnostics' Press Release -

Bayer Diabetes Care : introduction of the DIDGET™ blood glucose monitoring system in the United States

April 26, 2010 - Transforms Kids’ Diabetes Experience by Linking Play with Purpose – Bayer Diabetes Care announced the introduction of the DIDGET™ blood glucose monitoring system in the United States. The DIDGET meter is unique because it is the only blood glucose meter that connects directly to Nintendo DS™ and DS Lite gaming systems to help kids manage a lifelong disease by rewarding them for building consistent testing habits and meeting personalized blood glucose target ranges. Bayer’s DIDGET meter is now available for purchase in the US through CVS.com, Drugstore.com and Walgreens.com.
Bayer’s DIDGET meter links play with purpose for children with diabetes by tapping into kids’ existing passion for handheld gaming. The DIDGET meter positively reinforces consistent blood glucose testing habits by awarding points that kids can use to unlock new game levels and customize their gaming experience.
“As the first meter truly designed with kids in mind, the DIDGET meter can transform a child’s blood sugar testing experience from something they have to do into something they want to do,”... [PDF] Bayer Diabetes Care's Press Release -

PositiveID : Patent with the United States Patent and Trademark Office for its iGlucose System

Mar 23, 2010 - PositiveID Corporation (NASDAQ: PSID) announced that it has filed with the U.S. Patent and Trademark Office a non-provisional patent application for its iGlucose system, currently under development, which uses wireless SMS messaging to automatically communicate a diabetic patient's blood glucose levels from any data-capable glucose meter to an online database.

The iGlucose system is designed to communicate automatically with a wide variety of glucometers by utilizing electronics and stored information that will query and recognize a particular glucometer when connected to the device. This recognition aspect is unique because there are differences in how data is retrieved from different meters and manufacturers.

The iGlucose system also successfully addresses obstacles in SMS data transmission. Blood glucose and other data must be packed into a buffer to make most efficient use of the available bits, since SMS text messages are limited to 140 characters in a single message. Due to SMS transmission limitations, iGlucose utilizes proprietary data compression software and encryption algorithms to overcome these challenges... PositiveID's Press Release -

Medtronic : FDA Approval for Industry’s Most Advanced Integrated System for Diabetes Management

March 17, 2010 - Next Generation Integrated System – MiniMed Paradigm® REAL-Time Revel™ System – Incorporates Predictive Alerts to Help Patients More Tightly Control Diabetes – Medtronic, Inc. (NYSE:MDT) announced it has received U.S. Food and Drug Administration (FDA) approval for the MiniMed Paradigm® REAL-Time Revel™ System, the next generation of the industry’s only integrated diabetes management system (insulin pump therapy, continuous glucose monitoring (CGM) and diabetes therapy management software). The system incorporates new innovative CGM features including predictive alerts that can give early warning to people with diabetes so they can take action to prevent dangerous high or low glucose events.

“Medtronic is extending its lead in the path towards the artificial pancreas with this next generation integrated system and our ongoing advancements in algorithm development,”... Medtronic's Press Release -

Sanofi-aventis & AgaMatrix : worldwide agreement on blood glucose monitoring (BGM) solutions

March 31, 2010 - Partnership to Contribute to Improved Quality of Diabetes Care - Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and AgaMatrix Inc. announced that they have signed an agreement for the development, supply and commercialization of blood glucose monitoring (BGM) solutions.
Under the terms of the agreement, AgaMatrix and sanofi-aventis will co-develop innovative solutions in diabetes care with the aim to simplify patients’ and healthcare providers’ diabetes management experience. These BGM solutions will be exclusive to sanofi-aventis and are designed to be synergistic to sanofi-aventis’ diabetes portfolio.


“AgaMatrix provides us with an excellent opportunity to develop a comprehensive offer combining our leading insulins LANTUS® and APIDRA® with easy-to-use and reliable blood glucose monitors,”... [PDF]Sanofi-aventis' Press Release -

Intuity Medical : $64M Series D Financing

January 5, 2010 – Intuity Medical, Inc., a privately-held company developing innovative technologies in diabetes management, announced that it has secured a $64M Series D financing round. The funds were contributed by new investors Venrock and Emergent Medical Partners; and existing investors Investor Growth Capital, Thomas, McNerney and Partners, U.S. Venture Partners, and Versant Ventures.
Intuity will utilize the proceeds for the U.S. commercialization and distribution of its All-in-One System, following regulatory clearance. All-in-One is the world’s first fully integrated blood glucose monitor, providing greater convenience, ease of use and discretion in glucose testing... [PDF]Intuity Medical's Press Release -

Convincing results of Solianis’ multisensor system in home-use trial

October 13, 2008: Solianis’ multisensor system for non-invasive Continuous Glucose Monitoring is currently being tested by diabetic patients in the home and work environment. 12 patients have completed a 10-day trial aimed at assessing system reliability. Results indicate that the system tracks glucose in home-use settings and is sensitive to hypoglycemic glucose excursions.
With this proof of concept Solianis can now proceed to producing the final prototype. The company expects to launch its first product in Europe in 2010 after CE approval, targeting this non-invasive device at the insulin dependent diabetes population. Later model variants will address patients with diabetes and impaired glucose tolerance... [PDF] Solianis’ Press Release -

Echo Therapeutics : Issuance of New Patent for Symphony™ Transdermal Continuous Glucose Monitoring System

October 16, 2008 – Echo Therapeutics (OTCBB: ECTE) announced the issuance of U.S. Patent 7,432,069 covering compositions and methods for the preparation of a polyethylene glycol (PEG)- based hydrogel as a key component of Echo’s Symphony™ Transdermal Continuous Glucose Monitoring (tCGM) System... [PDF] Echo Therapeutics' Press Release -

Oxygen Biotherapeutics : License Agreement for Its Glucose Biosensor Technology

Sept. 22, 2008 - Oxygen Biotherapeutics, Inc. (OTCBB:OXBO) announced that the company has reached an agreement to license its glucose biosensor technology to Glucometrics, Inc. for applications involving the measurement and monitoring of glucose levels in diabetes patients.

Oxygen Biotherapeutics, Inc. will receive stock in Glucometrics and running royalties on a sliding scale based on worldwide net revenues from products derived from the licensed technology. Under terms of the agreement, the companies are not disclosing the royalty formula... Oxygen Biotherapeutics' Press Release -