DexCom Inc. (NSDQ:DXCM) posted its preliminary financial results for the 4th quarter, meeting analysts’ expectations on Wall Street and sending its shares upwards. The San Diego, Calif.-based company said it expects a total revenue of $168 million for Q4, a 28% increase from the same period in 2015, while analysts on The Street were looking for […]
Dexcom
Dexcom wins expanded FDA indication for G5 CGM
Dexcom Inc. (NSDQ:DXCM) said yesterday it won an expanded FDA indication for its G5 mobile continuous glucose monitoring system, now approved as a non-adjunctive device for diabetes treatment. With the approval, Dexcom touted that its device is now the ‘1st and only’ CGM system that can “make daily diabetes treatment decisions” without requiring a blood […]
J&J’s Animas wins FDA, Health Canada nod for OneTouch Vibe Plus insulin pump & CGM
Johnson & Johnson‘s (NYSE:JNJ) Animas Corporation subsidiary said today it won FDA approval and Health Canada authorization for its OneTouch Vibe Plus insulin pump and continuous glucose monitoring system. The OneTouch Vibe Plus features integration with Dexcom‘s (NSDQ:DXCM) G5 mobile CGM, and is designed for diabetes patients age 2 and older, the company said. System […]
DexCom, Tandem Diabetes dive on Q3 misses
Shares in both Tandem Diabetes Care (NSDQ:TNDM) and Dexcom Inc. (NSDQ:DXCM) took a dive today after the companies released 3rd quarter earnings results that missed expectations from analysts on Wall Street. Tandem Diabetes saw its stock plummet over 50% today after the diabetes-focused device posted losses per share that were nearly double of what analysts on […]
Dexcom logs German reimbursement win
Dexcom Inc. (NSDQ:DXCM) said yesterday it won reimbursement coverage for its continuous glucose monitoring systems through Germany’s Federal Joint Committee. The reimbursement change was approved by Germany’s Ministry of Health and covers technologies that provide alarms and alerts about glucose levels,San Diego, Calif.-based Insulet said. “We are thrilled that Dexcom CGM Systems are now accessible and […]
DexCom shares droop on Q2 release
Dexcom Inc. (NSDQ:DXCM) released its 2nd quarter earnings late yesterday, nailing Wall Street analysts expectations for revenue but missing on earnings per share by nearly double, seeing shares shrink in response. The San Diego, Calif.-based company reported losses of $20.2 million, or 24¢ per share, on sales of $137.3 million for the 3 months ended […]
FDA panel votes in favor of Dexcom G5 dosage label expansion
UPDATED July 22, 2016, with comment from Dexcom. An advisory panel recommended today that the FDA grant Dexcom‘s (NSDQ:DXCM) bid for a non-adjuctive dosing claim for its G5 continuous glucose monitor. The panel voted 8-2 on the safety question, 9-1 on the effectiveness question and 8-2 that the benefits outweigh the risks, according to a Leerink Partners note to investors. The […]
FDA readies panel on diabetes dosing label for Dexcom’s G5 CGM
The FDA yesterday released information on a panel its holding over Dexcom Inc.‘s (NSDQ:DXCM) G5 continuous glucose monitor, as the company seeks an expanded indication. The new indication would allow the next-gen CGM to replace fingerstick blood glucose testing, as opposed to operating as complimentary to them. The agency said that the accuracy of the G5 CGM […]
Dexcom expands in Phoenix with new manufacturing facility
Dexcom Inc. (NSDQ:DXCM) said today it is expanding its footprint in Phoenix with a new manufacturing facility which will focus on the company’s continuous glucose monitoring business. The new facility, slated to be 180,000 square feet, expects to add an additional 500 positions over the next several years f with initial manufacturing operations planned for the 2nd […]
Insulet touts new data showing reduced A1c levels with Omnipod system | American Diabetes Assn. 2016 Scientific Sessions
Insulet (NSDQ:PODD) last week touted the publication of new data supporting the benefits of its Omnipod insulin management system, with data supporting the systems’ efficacy at controlling blood glucose levels in patients switching from daily injections or tubed insulin pumps. Data from the company’s multi-center retrospective study was used in 2 online publications in the Journal […]
Diabetes: FDA panel to mull expanded indication for Dexcom G5 continuous glucose monitor
The FDA said it’s planning to convene an advisory panel in July to consider expanding the indication for the G5 mobile continuous glucose monitor made by Dexcom (NSDQ:DXCM). The Center for Devices & Radiological Health’s chemistry & toxicology panel is slated to meet July 21 to recommend whether the intended use for the Dexcom G5 should be […]