May 13,2015

BD Receives FDA Clearance for a Novel Infusion Set with BD FlowSmart™ Technology to Enhance the Use of Insulin Pumps

BD Medical, a segment of leading global medical technology company BD (Becton, Dickinson and Company) (NYSE: BDX), announced today it has received 510(k) clearance from the U.S. Food and Drug Administration for a new insulin infusion set with BD FlowSmart™ technology. Insulin infusion sets connect the insulin pump to the body. The new product is BD’s first within the diabetes infusion set category.

REGULATORY FDA

#insulin pump

View Analyst & Ambassador Comments
Go to original news
Jun 05,2015

Medtronic gets major FDA nod

Medtronic has received FDA 510(k) clearance for its MiniMed Connect device, which allows users of Medtronic's continuous glucose monitor (CGM) and insulin pump to view data from those devices on their smartphone. At the same time, Medtronic announced a partnership with Samsung to optimize the viewing of this CGM and pump data.

REGULATORY FDA

#cgm

#insulin pump

View Analyst & Ambassador Comments
Go to original news
Aug 24,2015

FDA Approves Dexcom G5® Mobile Continuous Glucose Monitoring System

Dexcom announced today that the U.S. Food and Drug Administration (FDA) has approved the Dexcom G5® Mobile Continuous Glucose Monitoring (CGM) System. With wireless Bluetooth® technology built into the device transmitter, the G5 Mobile CGM System is the first and only fully mobile CGM system approved by the FDA for both adults and children as young as 2 years of age that sends glucose data directly to a smartphone, freeing users from the need to carry a separate receiver. The new transmitter securely sends vital glucose information directly to an app on iOS-enabled devices for real-time diabetes management. Android applications will follow early next year. Like its predecessor, the G4 PLATINUM CGM with Share, users can also select up to five designated recipients, or "followers”. These followers can remotely monitor a patient's glucose information and receive alert notifications from almost anywhere.

REGULATORY FDA

#cgm

View Analyst & Ambassador Comments
Go to original news
Sep 09,2015

Tandem Diabetes Care Announces FDA Approval of t:slim G4 Insulin Pump with CGM Integration

Tandem Diabetes Care®, Inc. (NASDAQ: TNDM) today announced U.S. Food and Drug Administration approval of the t:slim G4™ Insulin Pump, the first and only touch-screen pump with continuous glucose monitoring (CGM) integration, for use by people 12 years of age or older who use insulin.

REGULATORY FDA

#insulin pump

View Analyst & Ambassador Comments
Go to original news
Sep 14,2015

Dexcom G5® Mobile Continuous Glucose Monitoring System Receives CE Mark

The Dexcom G5® Mobile Continuous Glucose Monitoring (CGM) System has received CE Mark (Conformite Europeenne) and will be available in several European countries in the coming weeks. This new system from Dexcom will be introduced to healthcare professionals and diabetes association delegates at the European Association for the Study of Diabetes (EASD) conference in Stockholm.

REGULATORY CE MARK

#cgm

View Analyst & Ambassador Comments
Go to original news
Dec 22,2015

LabStyle Innovations Receives U.S. FDA Marketing Clearance for the Dario Blood Glucose Monitoring System

LabStyle Innovations Corp. (OTCQB: DRIO), developer of the Dario™ Diabetes Management Solution, today announced that the United States Food and Drug Administration (FDA) has granted 510(k) clearance for the Dario Blood Glucose Monitoring System, including its components, the Dario Blood Glucose Meter, Dario Blood Glucose Test Strips, Dario Glucose Control Solutions and the Dario app on the Apple iOS 6.1 platform and higher.

REGULATORY FDA

#bgm

View Analyst & Ambassador Comments
Go to original news
Oct 20,2014

Dexcom Share, a smartphone-connected CGM charging cradle, gets FDA clearance

Dexcom Share, a cradle device that will allow users to send data from a Dexcom continuous glucose monitor to multiple smartphones, has received 510(k) clearance from the FDA. The system is designed to help parents and caregivers remotely track the glucose of a child, elderly parent, or spouse when the diabetes patient is at home or stationary. “Dexcom Share represents a significant advance in diabetes care by allowing people with diabetes to share important glucose information with their loved ones from afar,” Terrance H. Gregg, Chief Executive Office of Dexcom, said in a statement.

REGULATORY FDA

#cgm

View Analyst & Ambassador Comments
Go to original news
Nov 03,2014

FDA Approves Dexcom Software with Artificial Pancreas Algorithm

Dexcom announced today that the U.S. Food and Drug Administration (FDA) has approved new software for the Dexcom G4® PLATINUM CGM. The new Software 505 features the same advanced algorithm as used in artificial pancreas research around the world. The software will impact the performance of the Dexcom G4 PLATINUM.

REGULATORY FDA

#cgm

View Analyst & Ambassador Comments
Go to original news
Jan 28,2022

Insulet Announces FDA Clearance of its Omnipod® 5 Automated Insulin Delivery System, First Tubeless System with Smartphone Control

Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod® brand of products, today announced it has received clearance from the U.S. Food and Drug Administration (FDA) for its Omnipod® 5 Automated Insulin Delivery System (Omnipod 5) for individuals aged six years and older with type 1 diabetes. Omnipod 5 is the first tubeless automated insulin delivery (AID) system that integrates with the Dexcom G6 Continuous Glucose Monitoring (CGM) System and a compatible smartphone to automatically adjust insulin and help protect against highs and lows.

REGULATORY FDA

#insulin pump

View Analyst & Ambassador Comments
Go to original news
Feb 14,2022

ASCENSIA DIABETES CARE ANNOUNCES FDA APPROVAL OF THE EVERSENSE E3 CONTINUOUS GLUCOSE MONITORING SYSTEM FOR USE FOR UP TO 6 MONTHS

Ascensia Diabetes Care, a global diabetes care company, announces that its partner Senseonics Holdings, Inc. (NYSE American: SENS) has received approval from the U.S. Food and Drug Administration (FDA) for the next-generation Eversense ® E3 Continuous Glucose Monitoring (CGM) System. Ascensia plans to make the Eversense E3 sensor, which can be used for up to 6 months, available to patients in the U.S. during the second quarter of 2022.

REGULATORY FDA

#cgm

View Analyst & Ambassador Comments
Go to original news
Subscribe to REGULATORY