Jul 14,2016

Tandem Diabetes Care Announces FDA Clearance of Remote Software Update Tool for Insulin Pumps

Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the t:slim®, t:slim G4™ and t:flex® Insulin Pumps, today announced U.S. Food and Drug Administration (FDA) clearance of the Tandem Device Updater, a Mac® and PC-compatible tool for the remote update of Tandem insulin pump software.

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Jul 26,2016

Tandem Diabetes Care® Announces Expanded Pediatric Indication of t:slim® Insulin Pump for Ages 6 and Older

Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and the manufacturer of the t:slim®, t:slim G4™ and t:flex® Insulin Pumps, today announced FDA clearance of an expanded pediatric indication for the t:slim® Insulin Pump, lowering its use to children age 6 and older from children age 12 and older. The t:slim Pump is the first and only touchscreen insulin pump cleared by the U.S. Food and Drug Administration. This expanded pediatric indication applies to the current t:slim Pump features, with no changes to the existing user interface.

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Aug 11,2016

Ascensia Diabetes' new FDA-cleared glucometer wirelessly connects to Medtronic's new insulin pump

Ascensia Diabetes Care, a new business unit created this year when Panasonic Healthcare Holdings acquired Bayer Diabetes Care, has announced the launch and FDA 510(k) clearance of its Contour Next Link blood glucose monitor. Ascensia makes a line of connected and non-connected fingerstick glucometers. The Contour Next Link is a version that sends data wirelessly to Medtronic's MiniMed 630G insulin pump. According to Ascensia, it's the only FDA-cleared glucometer that connects to that pump, a new Medtronic offering that also just launched today .

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Aug 15,2016

BD Receives FDA Clearance for New Syringe Designed for the Administration of Humulin® R U-500 Insulin

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced it has received U.S. Food and Drug Administration (FDA) clearance for its new syringe for patients using Humulin R U-500 insulin vials. Humulin R U-500 insulin is indicated for patients with diabetes requiring more than 200 units of insulin per day.

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Sep 28,2016

Abbott gets FDA clearance to bring FreeStyle Libre Pro CGM to US

Abbott has received FDA Clearance for its FreeStyle Libre Pro system, a key milestone in bringing the company's unique take on the continuous glucose monitor to the United States. In Europe, where the system has had CE Mark clearance since September 2014, there is both a prescription and over-the-counter version available and the latter is smartphone compatible.

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Sep 29,2016

Medtronic gets FDA nod for artificial pancreas system, preps to launch Watson-powered Sugar.IQ app

Medtronic came out with two pieces of news yesterday around its connected diabetes efforts: an FDA clearance for a hybrid closed loop insulin delivery system and the first test cohort of its Sugar.IQ app, created in collaboration with IBM Watson.

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Nov 21,2016

ASCENSIA DIABETES CARE RECEIVES FDA CLEARANCE FOR THE APP-ENABLED CONTOUR®NEXT ONE BLOOD GLUCOSE MONITORING SYSTEM

Ascensia Diabetes Care announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the CONTOUR®NEXT ONE Blood Glucose Monitoring System (BGMS), marking a key step in making the next-generation system available to people living with diabetes in the U.S.

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Dec 06,2016

Voluntis gets both FDA and CE Mark for diabetes management app, Insulia

Voluntis, which makes companion software for medical devices or medications, has received both FDA clearance and the CE Mark for a type 2 diabetes management app called Insulia. The app, which is designed for people treated with basal insulin, is classified as a prescription-only medical device and will be available to patients and healthcare providers in the first half of 2017.

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Dec 20,2016

FDA approves Dexcom G5 for use without a fingerstick glucometer

The FDA has officially cleared the Dexcom G5 continuous glucose monitor to inform treatment decisions -- without the use of a fingerstick glucometer, other than for calibration. The G5 has been cleared for a while to complement a traditional glucometer, but this non-adjunctive clearance is the first of its kind according to Dexcom and the FDA, which both released statements.

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Dec 06,2016

One Drop Announces FDA Clearance and One Drop | Premium Launch in US, UK, and EU

One Drop today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and Conformité Européene (CE) mark approval for One Drop | Chrome, a beautiful blood glucose monitoring system that marries modern design with advanced medical and mobile technology.

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