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CGM

Abbott wins FDA clearance for its Lingo OTC glucose monitor

June 3, 2024 By Chris Newmarker

  Abbott has secured a 510(k) clearance from the FDA for its over-the-counter Lingo glucose-monitoring biowearable.  The clearance came on May 29, according to a listing on the FDA’s website. An Abbott spokesperson said the company was aware of the clearance and would provide more details later. FDA clearance for Abbott’s Lingo comes more than […]

Filed Under: 510(k), Diabetes, Digital Health, Featured, Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: Abbott, CGM

Abbott study says FreeStyle Libre users on insulin show lower HbA1c levels

October 3, 2023 By Sean Whooley

Abbott today announced real-world data associating its FreeStyle Libre CGM with significant HbA1c reductions. The continuous glucose monitor (CGM) played a part in significant reductions in HbA1c, the average glucose levels over a three-month period. It was also associated with a lower rate of hospitalization for people with type 2 diabetes on both multiple daily […]

Filed Under: Clinical Trials, Diabetes, Drug-Device Combinations, Health Technology, News Well, Patient Monitoring Tagged With: Abbott, CGM

FDA clearance for Dexcom G7 marks a ‘huge leap’ forward, COO Jake Leach says

December 21, 2022 By Sean Whooley

After plenty of anticipation — and a bit of waiting — the next-generation Dexcom G7 continuous glucose monitor is finally here. In mid-2021, Dexcom (Nasdaq:DXCM) CEO Kevin Sayer told Drug Delivery Business News that its next-generation CGM would be “wonderful.” At the time, he said enthusiasm over the Dexcom G7 sat at an all-time high. About […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Health Technology, News Well, Patient Monitoring, Regulatory/Compliance, Software / IT Tagged With: CGM, Dexcom

Dexcom focuses on early diabetes diagnosis as COVID links emerge

June 29, 2022 By Jim Hammerand

New evidence is showing that COVID-19 may increase a person’s risk of diabetes, but it could be years until we know for sure. In the meantime, Dexcom (Nasdaq:DXCM) is getting ready, VP of Global Clinical Initiatives Tomas Walker said. Walker recently spoke with Medical Design & Outsourcing to discuss the San Diego-based diabetes device developer’s […]

Filed Under: Blog, Diabetes, Featured, News Well Tagged With: CGM, coronavirus, covid, COVID-19, Dexcom, diabetes

Analysts say high payor coverage, increased CGM adoption bodes well for Abbott, Dexcom

March 30, 2022 By Sean Whooley

Analysts have suggested that companies like Abbott (NYSE:ABT) and Dexcom (Nasdaq:DXCM) may benefit from expected reimbursement progress. BTIG hosted a conference call with North Shore Medical Center (Salem, Massachusetts) Medical Director Dr. Gary Cohen and Healthcare Analytics, LLC analyst and consultant Dr. Joshua Cohen. The two experts offered insights into prescriber and patient interest in continuous glucose monitors (CGMs) […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Health Technology, News Well, Patient Monitoring, Wall Street Beat Tagged With: Abbott, Centers for Medicare and Medicaid Services (CMS), CGM, Dexcom, Reimbursement

Dexcom CEO touts unprecedented performance of G7 in clinical trial, awaits FDA decision

January 10, 2022 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Patient Monitoring, Regulatory/Compliance Tagged With: CGM, Dexcom, EU MDR, FDA

Senseonics expects FDA approval for next-gen 180-day CGM in ‘coming weeks’

January 5, 2022 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), News Well, Patient Monitoring, Pre-Market Approval (PMA), Regulatory/Compliance Tagged With: CGM, FDA, Senseonics

Senseonics touts new next-gen Eversense CGM data

June 28, 2021 By Sean Whooley

Senseonics (NYSE:SENS) today presented further positive data evaluating its next-generation Eversense continuous glucose monitoring system. Germantown, Md.–based Senseonics presented data from the Promise study at the American Diabetes Association Virtual 81st Annual Scientific Sessions. The data adds to positive results already presented by the company at the beginning of this month that demonstrated high levels […]

Filed Under: Clinical Trials, Diabetes, Featured, Patient Monitoring Tagged With: CGM, Senseonics

Study shows CGMs better at controlling blood sugar in type 2 diabetes

June 3, 2021 By Sean Whooley

Kaiser Permanente is touting a study demonstrating that using continuous glucose monitors offers better blood sugar control for patients with type 2 diabetes. Patients with insulin-treated type 2 diabetes using continuous glucose monitors (CGMs) typically had better blood sugar control and fewer visits to the emergency room for hypoglycemia, the study found. The study was […]

Filed Under: Clinical Trials, Diabetes, Featured, Patient Monitoring Tagged With: CGM, Dexcom, diabetes, Kaiser Permanente

Famed marathoner uses Abbott glucose sensor for training

April 12, 2021 By Brian Buntz

Kenyan long-distance runner Eliud Kipchoge is using a glucose sensor modeled after Abbott Laboratories’ FreeStyle Libre glucose monitor to optimize his training regimen.  The sensor, known as the Libre Sense Glucose Sport Biosensor, is the first device intended to help athletes track blood sugar rather than people with diabetes.  Get the full story from our […]

Filed Under: Diabetes, Digital Health Tagged With: Abbott, Abbott Laboratories, blood glucose monitoring, CGM, glucose sensor

How CGM tech has advanced in the 21st century

March 11, 2021 By Brian Buntz

The rapid evolution of the continuous glucose monitor (CGM) has brought flexibility and convenience to diabetes control. Continuous glucose monitors (CGMs) have transformed how many people with diabetes manage blood sugar, but attempts to monitor blood glucose have a long history. Efforts to manage glucose kicked off in earnest when researchers began measuring glucose in […]

Filed Under: Business/Financial News, Diabetes, Diagnostics, Digital Health, Drug Pumps, Drug-Device Combinations, Featured Tagged With: Abbott, CGM, Dexcom, Medtronic, Senseonics

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