Senseonics Announces CE Mark Approval for Eversense® XL CGM System
Senseonics Holdings, Inc. (NYSE-MKT-SENS) today announced it has received CE Mark approval for the Eversense® XL Continuous Glucose Monitoring (CGM) System. The Eversense XL System includes an extended life implanted glucose sensor lasting up to 180 days, a removable discreet smart transmitter, and a mobile app for display of real-time glucose readings. The Eversense XL System provides the world’s longest-lasting sensor, compared to the frequent weekly sensor insertions required by other CGM systems.
"We are pleased to announce the CE Mark approval of the Eversense XL System, representing another significant milestone for Senseonics. When we introduced the Eversense System last year, we were providing the longest-wear sensor with up to 90-day wear for people with diabetes. Now with the new Eversense XL System’s even longer sensor duration, patients can extend a single sensor wear over 3 seasons – inserting a new sensor in the Fall which will continue through the Winter to be replaced in Spring,” said Tim Goodnow, CEO and President of Senseonics. “As we continue to advance our product portfolio with extended long-term sensor capabilities, we are offering added convenience to support patients’ continuous glucose management. We are excited to bring this product to market in Europe in the fourth quarter of 2017.”
CE Mark indicates that the product design conforms to the requirements of the Active Implantable Medical Device Directive (AIMDD 90/385/EEC). Eversense XL is indicated for continually measuring interstitial fluid glucose levels in adults and to be used as an adjunctive device to complement information obtained from standard home blood glucose meters.
“We are all aware of the advantages of continuous glucose monitoring seen now in many studies, including improvements in glycemic control, quality of life and reduction in hypoglycemia,” said Dr. Pratik Choudhary, Senior Lecturer and Consultant in Diabetes at King’s College London. “The benefits have been linked with long-term usage, which for many requires changing sensors every week. Eversense now offers a unique option for people who want to use CGM long term, with a long-lasting sensor that has demonstrated accuracy.”
Eversense XL - advanced CGM technology with best in class sensor wear time for people with diabetes #ExtendedLifeCGM #EversenseCGM #AdvancedCGMTechnology
Senseonics Holdings, Inc. is a medical technology company focused on the design, development and commercialization of transformational glucose monitoring products designed to help people with diabetes confidently live their lives with ease. Senseonics' CGM systems, Eversense and Eversense XL, include a small sensor inserted completely under the skin that communicates with a smart transmitter worn over the sensor. The glucose data are automatically sent every 5 minutes to a mobile app on the user's smartphone.
Any statements in this press release about future expectations, plans and prospects for Senseonics, including statements about the continued advancement of Senseonics’ product portfolio, the commercialization of Eversense XL in Europe and other statements containing the words “expect,” “intend,” “may,” “will,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and the completion of the underwritten public offering on the anticipated terms or at all, uncertainties inherent in the expanded commercial launch of Eversense and such other factors as are set forth in the risk factors detailed in Senseonics’ Annual Report on Form 10-K for the year ended December 31, 2016, Senseonics’ Quarterly Report on Form 10-Q for the quarter ended June 30, 2017 and Senseonics’ other filings with the SEC under the heading “Risk Factors.” In addition, the forward-looking statements included in this press release represent Senseonics’ views as of the date hereof. Senseonics anticipates that subsequent events and developments will cause Senseonics’ views to change. However, while Senseonics may elect to update these forward-looking statements at some point in the future, Senseonics specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing Senseonics’ views as of any date subsequent to the date hereof.
Senseonics Holdings, Inc.
R. Don Elsey, 301-556-1602
Chief Financial Officer
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
"Panasonic Prime Smash!" Has Been Given a Complete Makeover - An iPhone, iPad Game That Awakens Children's Interest in Mathematics26.9.2018 03:05 | Pressemelding
On August 28, 2018, Panasonic Corporation gave the iPad app, "Panasonic Prime Smash!" a complete makeover. The new release includes the iOS 11 compatible iPhone app as well. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180925006294/en/ The screen of "Panasonic Prime Smash!": In the game, balls with numbers are blown. If it is a prime number, capture it by tapping the ball. (Graphic: Business Wire) [Video] Smartphone game application "Panasonic Prime Smash!" https://channel.panasonic.com/contents/24401/ "Panasonic Prime Smash!" overview "Panasonic Prime Smash!" is a game app that teaches children about the atom of numbers, or prime numbers in a fun, enjoyable way. Balls bearing numbers will appear on the screen one after another. If the number is a prime number, you touch that number. If the number is not a prime number, you "Smash" it, transform it into a prime number, and then touch it. That number will be added to your t
Toshiba's New Global Brand Identity to Promote Growth and Development26.9.2018 02:01 | Pressemelding
Toshiba Corporation (TOKYO:6502) has today unveiled a new global brand identity the “Essence of Toshiba,” a restatement of its abiding purpose and values. The Essence of Toshiba replaces Toshiba’s previous Group Management Vision, Brand Statement and Brand Tagline. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180925006288/en/ (Graphic: Business Wire) The Essence of Toshiba will be applied across all Toshiba Group companies and in all markets, as part of an initiative to harmonize and integrate the Group’s diverse businesses and operations around the world. As a forward-looking and entrepreneurial Toshiba continues its business transformation, the restated corporate philosophy and new brand identity will provide a strong and consistent framework for all communication. A summation of core management values and the DNA that has shaped the company for 143 years, the Essence of Toshiba will guide Toshiba in building a sustainab
Moody’s Names Mona Breed as Chief Information Officer25.9.2018 20:30 | Pressemelding
Moody’s Corporation (NYSE:MCO) announced today that Mona Breed will join the company as Chief Information Officer (CIO), effective October 15, 2018. As CIO, Ms. Breed will lead Moody’s global technology infrastructure and programs. She will report to Raymond McDaniel, President and Chief Executive Officer of Moody’s. “With nearly 30 years of experience embedding innovation and technology programs at leading financial and professional services firms, Mona’s insight and expertise will be invaluable as we enhance our technology capabilities and leverage our investments,” said Raymond McDaniel President and Chief Executive Officer of Moody’s. Prior to joining Moody’s, Ms. Breed led IT infrastructure for Oppenheimer Funds, where she drove innovation and transformation, including the firm’s cloud computing, unified communication and collaboration, data center operations and workplace technologies. She has also held senior technology roles at PricewaterhouseCoopers and Apollo. Ms. Breed succe
IWBI Announces First WELL Portfolio Participants25.9.2018 18:00 | Pressemelding
The International WELL Building Institute™ (IWBI™) announced today the first participants in WELL Portfolio™, a new streamlined pathway for WELL Certification™ for multiple new or existing buildings and tenant spaces in a single portfolio. Being released as part of the WELL v2™ pilot, the latest iteration of the WELL Building Standard™ (WELL™), it is part of a suite of enhancements to WELL that addresses growing demand across the building industry for a program that helps owners, developers and tenants streamline and scale health and wellness upgrades to their real estate assets. The announcement quickly follows the launch of WELL v2, the second iteration of IWBI’s pioneering WELL Building Standard. The addition of an early phase review process enabling projects to seek the WELL D&O™ designation, introduced in WELL v2, allows portfolio projects to move through the certification process in a more streamlined and systematic fashion across their asset base, with a specific focus on polici
Mobile Industry Accelerating Delivery of Sustainable Development Goals, According to Latest GSMA Report25.9.2018 17:00 | Pressemelding
The global mobile industry is demonstrating significant and measurable impact in contributing to the UN’s Sustainable Development Goals (SDGs) and is strengthening its commitment to improving lives around the world, according to a new GSMA study. The 2018 edition of the GSMA’s annual ‘Mobile Industry Impact’ report, published at the UN General Assembly this week, found that the industry has continued to increase its contribution against all 17 Goals since mobile become the first sector in the world to commit to delivery of the SDGs in 2016. This growing impact reflects mobile’s unprecedented global scale, which provides a platform to connect unconnected communities, reduce poverty, improve access to healthcare and education, and drive sustainable economic growth. “More than two-thirds of the people on the planet are now connected to a mobile network and, for many, mobile is the primary – sometimes only – channel for accessing the internet and life-enhancing services,” commented Mats Gr
PMI: Taking Bold Action for Global Change: a Conversation on Tobacco Today and Transformation for Tomorrow25.9.2018 15:43 | Pressemelding
During the 2018 Concordia Annual Summit, taking place in September 24 & 25 in New York, André Calantzopoulos, CEO of Philip Morris International, delivered a speech highlighting the need to have a dialogue between the industry, leaders, policy-makers, scientists, medical, and public health professionals in order to provide the 1.1 billion people who smoke with better alternatives to cigarettes. The Concordia Annual Summit, which coincides with the United Nations General Assembly (UNGA) meeting, convenes the world’s most prominent business, government, and nonprofit leaders to foster dialogue and enable effective partnerships for positive social impact. The remarks by André Calantzopoulos follow: “I'm the Chief Executive Officer of a tobacco company. I’m here today because, as global leaders come together in New York for the United Nations General Assembly, this is the time and place to discuss today's problems and their potential solutions. “Smoking tobacco is a behavioral risk factor