Diabetes devices maker DexCom (NSDQ:DXCM) got a lot of love from Wall Street after issuing its latest quarterly report, with DXCM shares gaining 14.5% since last week.
Dexcom
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May 2014 medical device recalls | Regulatory news for the week of June 9, 2014
Medical device recalls for May 2014
June 3, 2014 by MassDevice staff
May Summary
Class I recalls: 9
Class II recalls: 137
Diabetes: DexCom wins FDA approval for professional glucose monitor
DexCom said it won pre-market approval from the FDA for its Dexcom G4 Platinum Professional continuous glucose monitor, touting it as the only professional-version CGM to offer real-time, unblinded feedback for patients and caregivers.
Patients use the G4 Platinum Professional CGM for 7 days as the device logs the rate and direction of glucose changes every 5 minutes.
FDA flags Dexcom on reporting compliance | Medtech regulatory news for the week of Mar. 31, 2014
Diabetes: FDA releases DexCom warning letter
The FDA’s release of a warning letter sent Dexcom Inc. (NSDQ:DXCM) this month reveals that the glucose monitoring company failed to report at least 4 incidents of low blood sugar requiring medical attention and at least 1 instance in which the device shocked a patient.
Diabetes: FDA warns Dexcom on adverse event reports
Dexcom Inc. (NSDQ:DXCM) said the FDA flagged its adverse event reporting system for not being compliant with new medical device reporting rules.
The federal watchdog agency issued a warning letter to San Diego-based Dexcom, which makes continuous glucose monitors for diabetics, after an inspection in November 2013, according to a press release.