BioWorld - Thursday, December 18, 2025

Articles Tagged with ''Dexcom Inc.''

Toy bulldozer moving FDA letter blocks

FDA provides five more device classifications via de novo petition

Feb. 18, 2022
By Mark McCarty
The FDA’s device center has long been at the task of reclassifying legacy devices that promise a moderate degree of risk, but successful de novo device applications also call for a class II listing. The agency recently posted five such risk classifications, including for a device developed by Edwards Lifesciences Corp., of Irvine, Calif.
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Omnipod 5, Dexcom G6 devices with mobile app on smartphone

FDA clears Insulet Omnipod 5 tubeless ‘artificial pancreas’

Jan. 28, 2022
By Annette Boyle
Insulet Corp. received FDA clearance for its Omnipod 5 closed-loop automated insulin delivery (AID) system for patients aged six and older who have type 1 diabetes on Friday, Jan. 28, making it the first tubeless “artificial pancreas” system to get the FDA greenlight. The Omnipod 5 works with Dexcom Inc.’s widely used G6 continuous glucose monitor (CGM) to self-adjust insulin dosing using its Smartadjust algorithm.
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doctor, checklist, apple, prescription bottle and blood glucose meter illustration
A look back as we head into 2022

Top Med-tech Trends of 2021: Diabetes market poised for growth, despite pandemic

Dec. 20, 2021
By Meg Bryant
Diabetes care will continue to evolve in 2022. New digital offerings and advanced algorithms, along with new product launches in insulin pumps and continuous glucose monitoring (CGM) will power growth in the future, according to key analysts. While many medical device sectors have suffered during the COVID-19 pandemic, diabetes care has continued to grow.
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Lithuania and its flag on globe
2021 Life Sciences Baltics

Lithuania’s growing life sciences sector spotlighted at Life Sciences Baltics conference

Oct. 5, 2021
By Catherine Longworth
It may be a small country, but Lithuania has lofty ambitions. The Baltic country is emerging as one of Europe’s rising life science stars, with annual growth of 22% and targeting 5% of its GDP to be generated by the life sciences sector in 2030. Export of medical devices has also doubled since 2008, with majority of the country’s production reaching the U.K., France, Russia, Spain and the U.S.
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Regulatory front for April 7, 2021

April 7, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA hits company for deviations from drug, device GMPs; Stryker undertakes correction for AEDs; MHRA: Creams, ointments may interfere with CGM function; NICE says liver perfusion suffers for want of evidence of efficacy; NIAID testing vaccine allergy hypothesis; EC provides emergency funding for COVID-19 research; Medtronic splits Ninth Appeals’ review of lower court decision; Industry, docs push back on prior authorization.
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Product image

Abbott scores European win with Libre 3

Sep. 28, 2020
By Liz Hollis
Abbott Laboratories is celebrating another win with its continuous glucose monitoring (CGM) technology. This time, the company revealed that it has scored the CE mark for its next-generation Freestyle Libre 3 system. Wells Fargo’s Larry Biegelsen noted that the arrival of the CE mark came slightly earlier than his group had expected.
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7-20 Movano CGM rendering

Movano raises $10M to back wearable, noninvasive continuous glucose monitor

July 20, 2020
By Stacy Lawrence
Commercial continuous glucose monitors (CGMs) require some access to a patient’s blood, typically through tiny needles embedded in a wearable patch sensor. But Movano Inc. is working to develop a CGM that is based on radio frequency technology to monitor glucose levels via a noninvasive, external wearable, likely in a form factor akin to a watch or a wrist-worn fitness wearable.
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