Tag: CGM

NEW YORK – Alexandra Stchaslivteseva, 52, of New York has been arrested for allegedly offering and paying illegal health care kickbacks and money laundering, resulting in Medicare paying more than $17.3 million in false claims. She allegedly offered and paid kickbacks and bribes to several purported telemedicine companies and marketing companies in exchange for completed doctor orders of medically unnecessary orthotic braces and continuous glucose monitors for Medicare beneficiaries. Stchastlivtseva...

SAN DIEGO – DexCom has received clearance from the U.S. Food and Drug Administration for its next-generation Dexcom G7 Continuous Glucose Monitoring (CGM) System for people with all types of diabetes ages two years and older. “There’s a reason Dexcom has the best-selling real-time CGM on the market,” said Kevin Sayer, chairman, president and CEO of Dexcom. “For more than a decade, we’ve pioneered generation after generation of sensing technology that consistently...

PARSIPPANY, N.J. – Diabetes management is taking a “big leap forward” with the Eversense E3, an implantable continuous glucose monitor, which was recently approved for use up to six months, says Elaine Anderson, head of the Eversense CGM business unit at Ascensia Diabetes Care.  “This is double the lifetime of what people had – you replace it twice (a year),” she said. “It’s not sacrificing accuracy, it’s easy on, easy off so you can take...

GERMANTOWN, Md. – Senseonics has announced approval by the U.S. Food and Drug Administration for its next-generation Eversense E3 CGM System. The Eversense E3, which includes proprietary sacrificial boronic acid technology to extend longevity to six months, is planned to be available in the U.S. through Ascensia Diabetes Care, the company’s global commercial partner, beginning in the second quarter of 2022. “We repeatedly hear from our patients with diabetes that what they desire...

DUBLIN, Ireland - Although Medtronic is a leader in insulin pump technology, the majority of people with diabetes who use insulin still opt for injections—that's why the company wants to “close the loop” for those patients. In August, Medtronic announced it had acquired Companion Medical, the manufacturer of?InPen, a smart insulin pen system paired with an integrated diabetes management app that helps with insulin dosing and tracking. “It became apparent to us there was a...

NEW YORK - Dario Health has partnered with MediOrbis to expand the service offering for its blood glucose monitoring system with a full suite of telemedicine capabilities for its 50,000 active users. With Dario's most recent app, users may now access a full complement of physician-directed patient care from home and other remote locations, a capability it says is necessary in the new reality of “stay at home.” “This partnership broadens Dario's SaaS-based service offering by delivering...

NEW YORK - One Drop has developed a model to predict blood glucose levels for people using continuous glucose monitors. Using more than 10 million hours of CGM data from One Drop users, the model accurately predicted blood glucose levels within 30 mg/dL of the CGM-measured values up to 120 minutes in advance. At 30 minutes, predictions were within 30 mg/dL more than 97% of the time; at 60 minutes, they were within 30 md/dL more than 75% of the time; and at 120 minutes, within 30 mg/dL more than 55%...

SAN DIEGO - Dexcom's G6 Pro CGM has received clearance from the U.S. Food and Drug Administration, allowing healthcare professionals to use the device with their patients. The Dexcom G6 Pro is the only single use, professional CGM that gathers real-time glucose data over a 10-day period, and offers both a blinded and un-blinded mode. The data allows providers to adjust a patient's therapy and help them modify daily behavior. “At Dexcom, we are continuing to drive innovation in wearable health...

SAN DIEGO - Tandem Diabetes Care, a manufacturer of touchscreen insulin pumps, has submitted a medical device license application to Health Canada to market its t:slim X2 Insulin Pump with Dexcom G5 Mobile continuous glucose monitoring integration. The company plans to launch the pump in Canada in the second half of 2018, subject to regulatory approvals. “This application is another important step toward achieving our strategic goal of bringing the benefits of the t:slim X2 Insulin Pump to...

PARSIPPANY, N.J. - Ascensia Diabetes Care and Dexcom have hammered out a commercial agreement that they expect to increase access to the Dexcom G5 continuous glucose monitoring system. Per the agreement, Ascensia's ContourNext One blood glucose monitoring system will be provided in the bundle of supplies for the Dexcom G5. The role of the ContourNext: to provide highly accurate readings for CGM calibration, something people who use the G5 do on a regular basis to verify sensor readings are on track....