ASCENSIA DIABETES CARE’S ALLIANCE PARTNER RECEIVES FDA 510(K) CLEARANCE FOR OMNIPOD DASH™ INSULIN MANAGEMENT SYSTEM IN THE U.S.
TOKYO, June 13, 2018 ― Ascensia Diabetes Care’s alliance partner, Insulet Corporation (NASDAQ: PODD), the leader in tubeless insulin pump technology, recently announced FDA 510(k) clearance of the Omnipod DASH™ Insulin Management System (Omnipod DASH). Ascensia is a wholly-owned subsidiary of PHC Holdings Corporation.
The Omnipod DASH features Bluetooth® wireless technology for connectivity between the color touch-screen Personal Diabetes Manager (PDM), tubeless waterproof pump (Pod), and the CONTOUR®NEXT ONE blood glucose meter, enabling seamless transfer of blood glucose readings to the PDM’s bolus calculator. The CONTOUR®NEXT ONE has been optimized for use with the Omnipod DASH System and is the meter designed to wirelessly transmit readings directly to the PDM.
In June 2017, Ascensia signed a development agreement to connect the CONTOUR®NEXT ONE blood glucose monitoring system with Insulet’s Omnipod DASH. In January 2018, this was followed by a non-exclusive commercial agreement, where Insulet will distribute the CONTOUR®NEXT ONE BGMS with the Omnipod DASH. Once launched, recipients of Omnipod DASH will receive the CONTOUR®NEXT ONE meter and CONTOUR®NEXT test strips packaged with their insulin pump.
Robert Schumm, Region Head Americas, Ascensia Diabetes Care, said: “We are delighted that the Omnipod DASH has received FDA 510(k) clearance and are proud that our CONTOUR®NEXT ONE system has been optimized for use with it. By seamlessly providing critical blood glucose data to the Omnipod DASH for calculating insulin dosing, we hope that this new innovation can further simplify and improve the lives of people with diabetes."
Insulet’s press release is available at:
About PHC Holdings Corporation
Incorporated in 2014, PHC Holdings Corporation is a global healthcare company. Its subsidiaries include PHC Corporation and Ascensia Diabetes Care Holdings AG. Committed to its corporate mission, "We contribute to the wellbeing of society through our diligent efforts by creating new value propositions for all the people who wish for better health," the company develops, manufactures, sells and services medical equipment and solutions through its three core businesses for medical devices, healthcare IT and life sciences. PHC Holdings Corporation group’s consolidated net sales in FY2016 marks 187.4 billion yen with global distribution of products and services for more than 125 countries. PHC Holdings Corporation changed its name from Panasonic Healthcare Holdings Co., Ltd. in April, 2018.
For further information on PHC Holdings Corporation, please visit https://www.phchd.com/
About Ascensia Diabetes Care
Ascensia Diabetes Care is a global specialist diabetes care company, dedicated to helping people living with diabetes. Our mission is to empower people living with diabetes through innovative solutions that simplify and improve their lives. We use our innovation and specialist expertise in diabetes to develop high quality solutions and tools that make a positive, daily difference for people with diabetes.
Home to the world renowned CONTOUR® portfolio of blood glucose monitoring systems, our products combine advanced technology with user-friendly functionality that help people with diabetes to manage their condition. We are committed to continued research, innovation and development of new products and solutions. As a trusted partner in the diabetes community, we collaborate closely with healthcare professionals and other partners to ensure our products meet the highest standards of accuracy, precision and reliability, and that we conduct our business compliantly and with integrity.
Ascensia Diabetes Care was established in 2016 through the sale of Bayer Diabetes Care to Panasonic Healthcare Holdings Co., Ltd. Ascensia Diabetes Care products are sold in more than 125 countries. Ascensia Diabetes Care has around 1,700 employees and operations in 31 countries.
For further information, please visit the Ascensia Diabetes Care website at: http://www.ascensia.com
*Ascensia and Contour are trademarks and/or registered trademarks of Ascensia Diabetes Care. The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc., and any use of such marks by Ascensia Diabetes Care Holdings AG or Insulet Corporation is under license.