DexCom: Should Investors Buy Into The Story?
With Valuation Looking Stretched, DexCom Is Getting Risky
Andy Batts • 68 Comments
Andy Batts • 68 Comments
Fri, Jul. 22, 9:11 AM
Thu, Jul. 21, 5:19 PM
- The FDA's Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee voted in favor of approval of Dexcom's (NASDAQ:DXCM) G5 Mobile Continuous Glucose Monitoring (CGM) System as a replacement for users' blood glucose meters and to make treatment decisions based on the results from the G5. The filing was submitted as a supplement to its previously approved premarket approval application (PMA).
- Specifically, the Panel voted 8-2 in favor of the safety of the G5, 9-1 backing its effectiveness and 8-2 that the benefits outweigh the risks.
Thu, Jul. 21, 9:13 AM
- The FDA's Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee meets today and tomorrow to review two applications for diabetes-related devices.
- Today, it will discuss Dexcom's (NASDAQ:DXCM) premarket approval application (PMA) panel-track supplement for a proposed change in the intended use of its Dexcom G5 Mobile Continuous Glucose Monitoring System (CGM) that will allow patients to use the device as a replacement for their blood glucose meters and make treatment decisions based on the glucose concentration in the interstitial fluid reported by the CGM.
- Tomorrow, the panel will discuss Alere's (NYSE:ALR) 510(k) submission seeking clearance of its Afinion HbA1c Dx point-of-care (POC) test system, an in vitro diagnostic test for the quantitative determination of glycated hemoglobin (% hemoglobin A1c) in human whole blood. Current clinical guidelines do not support POC hemoglobin tests to diagnose diabetes.
- FDA briefing doc - Dexcom
- Dexcom briefing doc
- FDA briefing doc - Alere
- FDA briefing doc appendices - Alere
- Alere briefing doc
- Panel questions - Alere
Fri, May 27, 5:39 PM
Wed, Apr. 27, 4:11 PM
Tue, Apr. 26, 5:35 PM
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Tue, Feb. 23, 4:06 PM
Mon, Feb. 22, 5:35 PM
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Nov. 4, 2015, 4:24 PM
- DexCom (NASDAQ:DXCM): Q3 EPS of -$0.07 misses by $0.06.
- Revenue of $105.2M (+52.5% Y/Y) beats by $5.32M.
- Shares +1%.
Nov. 3, 2015, 5:35 PM
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Oct. 15, 2015, 12:46 PM
Oct. 15, 2015, 9:13 AM
Oct. 14, 2015, 5:39 PM
Aug. 11, 2015, 8:35 AM
- DexCom (NASDAQ:DXCM) will jointly develop a series of next-generation continuous glucose monitoring (CGM) products with Google's life sciences group. The devices, based on Google's miniaturized electronics platform and DexCom's sensor technology, will be smaller and less expensive that existing alternatives. The collaboration will also provide an opportunity to better utilize the data generated by the CGM devices to significantly improve outcomes and reduce diabetes care-related costs.
- Initial product development will focus on minimizing the cost and size of body-worn CGM components. The bandage-sized sensors, connected to the cloud, will be disposable and will be appropriate for use across all diabetes markets.
- Under the terms of the agreement, DexCom retains all sales and distribution rights to the products developed under the partnership. Google will receive an upfront payment, milestones and sales-based royalties.
Aug. 5, 2015, 4:15 PM
- DexCom (NASDAQ:DXCM): Q2 EPS of -$0.05 misses by $0.02.
- Revenue of $92.9M (+59.6% Y/Y) beats by $8.09M.
Aug. 4, 2015, 5:35 PM
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DexCom, Inc. is a medical device manufacturing company. The company is focused on the design, development and commercialization of continuous glucose monitoring systems for ambulatory use by people with diabetes and for use by healthcare providers in the hospital for the treatment of both... More
Industry: Medical Instruments & Supplies
Country: United States
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