Roche announced today that it launched its Cobas Pulse system in select countries accepting CE mark approval in Europe. Basel, Switzerland–based Roche designed its Cobas Pulse system to combine the form factor of a high-performance blood glucose meter with simple usability and expanded digital capabilities comparable to that of a smartphone. The platform joins Roche’s […]
Patient Monitoring
Glytec partners with Roche to enhance insulin dosing decision support software
Glytec announced today that it entered into a strategic partnership with Roche Diagnostics USA for a digital health collaboration. Waltham, Massachusetts-based Glytec’s partnership combines its FDA-cleared Glucommander insulin dosing decision support software with Roche’s expertise in medical devices and IT solutions in an effort to address the challenges associated with inpatient blood sugar management at […]
Dexcom CEO touts unprecedented performance of G7 in clinical trial, awaits FDA decision
Exciting new data for the next-generation Dexcom (NSDQ:DXCM) G7 continuous glucose monitor (CGM) surprised even the company’s leadership. Dexcom Chair, President & CEO Kevin Sayer, presenting clinical study results for the G7 at the 40th Annual J.P. Morgan Healthcare Conference, has previously lauded the expected impact of the wearable glucose monitor, and the new data […]
Medtronic CEO confirms FDA warning could affect approval timing for next-gen diabetes tech
An FDA warning over Medtronic’s (NYSE:MDT) diabetes business introduces uncertainty into new approvals, the company’s CEO said. Last month, Medtronic received an FDA warning letter highlighting inadequacies in specific medical device quality system requirements at its diabetes business’ Northridge, California, facility. Today at the 40th Annual J.P. Morgan Healthcare Conference, CEO Geoff Martha said there […]
Abbott CEO touts future of biowearables in first-ever healthcare company keynote at CES
Abbott (NYSE:ABT) Chairman & CEO Robert B. Ford highlighted what the future holds as he presented the first healthcare keynote ever at CES. Abbott Park, Illinois-based Abbott is designing biowearables based on its Freestyle Libre platform, with sensor technology designed to track key signals in the body like glucose, ketones and lactate, and could even one […]
Senseonics expects FDA approval for next-gen 180-day CGM in ‘coming weeks’
Senseonics (NYSE:SENS) announced that it anticipates the FDA to decide within weeks on approval of its new CGM system. The company seeks a premarket approval supplement for the next-generation Eversense 180-day implantable continuous glucose monitoring (CGM) system. Data presented earlier this year demonstrated strong accuracy. The next-generation Eversense matched performance levels compared to the current […]
Zacks says Medtronic will gain from expanded CMS coverage for CGMs
Zacks Equity Research today reported that Medtronic (NYSE:MDT) stands to gain from yesterday’s CMS coverage expansion for diabetes technology. CMS’s expanded coverage, confirmed by Medtronic yesterday, covers all types of CGMs (continuous glucose monitors), including adjunctive and non-adjunctive CGMs. The coverage includes CGMs that integrate with Medtronic insulin pumps. Zacks said the new rule will likely […]
CMS expands Medicare coverage to CGMs that integrate with Medtronic insulin pumps
Medtronic (NYSE:MDT) announced today that the U.S. Centers for Medicare & Medicaid Services (CMS) will expand coverage for CGMs. CMS’ expanded coverage covers all types of CGMs (continuous glucose monitors), including adjunctive and non-adjunctive CGMs, and it notably covers CGMs that integrate with Medtronic insulin pumps. According to a news release, the proposed rule was […]
Senseonics wins CE mark for remote glucose monitoring app for Android users
Senseonics (NYSE:SENS) announced today that its Eversense NOW remote monitoring app for Android received CE mark approval. Germantown, Maryland-based Senseonics already received such approval for the Eversense NOW iOS platform and can now offer it in Europe on the Android operating system. The company expects to make the Eversense NOW remote monitoring app for Android […]
Bigfoot Biomedical announces trio of new senior hires
Bigfoot Biomedical announced today that it appointed three senior hires with experience in the diabetes and healthcare sectors. Milpitas, California–based Bigfoot hired Matthew Clemente as SVP of development, Robin A. Beadle as VP of marketing and Scott Snead as VP of national accounts. All three positions are newly created. Bigfoot said in a news release […]