May 06,2020

DarioHealth Self-test Blood Glucose Meters Can Now Be Utilized Within Hospitals During the COVID-19 Pandemic Per Recently Issued Emergency FDA Guidelines

DarioHealth Corp. (Nasdaq: DRIO), a global digital therapeutics (DTx) innovator, announced today that in an effort to reduce contact between healthcare providers and patients in hospital settings, limit COVID-19 exposure, and preserve personal protective equipment (PPE), the U.S. Food and Drug Administration (FDA) has recognized that home-use blood glucose meters including Dario's smartphone-connected metering device may be used by patients with diabetes who are hospitalized due to COVID-19 to check their own blood glucose levels and provide the readings to the health care personnel caring for them.

REGULATORY FDA

#bgm

View Analyst & Ambassador Comments
Go to original news
May 22,2020

Medtronic Guardian™ Connect Continuous Glucose Monitoring (CGM) System for Diabetes Now Compatible with Android Devices

Medtronic (NYSE:MDT), the global leader in medical technology, today announced U.S. Food and Drug Administration (FDA) approval for the Android™ version of its Guardian™ Connect continuous glucose monitoring (CGM) system.

REGULATORY FDA

#cgm

View Analyst & Ambassador Comments
Go to original news
Jun 03,2020

Welldoc Receives FDA Clearance for Long-Acting Insulin Support for Award-Winning Digital Health Solution BlueStar®

Welldoc, revolutionizing digital health with the first FDA-cleared Software as a Medical Device (SaMD) for diabetes, announced today that U.S. Food and Drug Administration (FDA) has cleared an additional feature for the digital health product BlueStar Rx which supports individuals using long-acting insulin. The Insulin Adjustment Program (IAP), supports the process of basal insulin titration by health care providers for adults with type 2 diabetes.

REGULATORY FDA
View Analyst & Ambassador Comments
Go to original news
Jun 11,2020

Medtronic Secures CE Mark for MiniMed™ 780G Advanced Hybrid Closed Loop System Designed to Further Simplify Type 1 Diabetes Management

Medtronic plc(opens new window) (NYSE:MDT), the global leader in medical technology, today announced CE (Conformité Européenne) Marking of its MiniMed™ 780G system, a next generation closed loop insulin pump system for the treatment of type 1 diabetes in people age 7 to 80 years. Leveraging the company’s most advanced SmartGuard™ algorithm, the system automates the delivery of both basal insulin and correction boluses every five minutes to help people with diabetes avoid highs and lows with greater ease.

REGULATORY CE MARK

#closed loop

#insulin pump

View Analyst & Ambassador Comments
Go to original news
Jun 15,2020

ABBOTT'S FREESTYLE® LIBRE 2 ICGM CLEARED IN U.S. FOR ADULTS AND CHILDREN WITH DIABETES, ACHIEVING HIGHEST LEVEL OF ACCURACY AND PERFORMANCE STANDARDS

Abbott (NYSE: ABT), the worldwide leader in continuous glucose monitoring (CGM), announced today the U.S. Food and Drug Administration (FDA) cleared its next-generation FreeStyle® Libre 2 integrated continuous glucose monitoring (iCGM) system for adults and children ages 4 and older with diabetes. This is the only iCGM system with optional real-time alarms that measures glucose levels every minute, meeting the highest level of accuracy standards over 14 days, including superior day one accuracy compared to the other iCGM and excellent accuracy and alarm performance at low end glucose levels.

REGULATORY FDA

#cgm

View Analyst & Ambassador Comments
Go to original news
Jun 17,2020

Tandem Diabetes Care Announces Expanded Pediatric Indication of the t:slim X2 Insulin Pump with Control-IQ Advanced Hybrid Closed-Loop Technology

Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin delivery and diabetes technology company, today announced U.S. Food and Drug Administration (FDA) clearance of an expanded pediatric indication for the t:slim X2™ insulin pump with Control-IQ™ technology to children age six and older.

REGULATORY FDA

#insulin pump

#closed loop

View Analyst & Ambassador Comments
Go to original news
Jul 07,2020

Brighter expands the product portfolio - has received the CE mark for the new product "Actiste® Mini"

Brighter AB (publ) has today received EC certifications (CE marking) for its new product Actiste Mini – a smart and user-friendly blood glucose meter with global out-of-the-box connectivity via eSIM, which supports the successful management and supervision of diabetes.

REGULATORY CE MARK

#bgm

View Analyst & Ambassador Comments
Go to original news
Sep 01,2020

Medtronic Announces FDA Approval for Minimed™ 770G Insulin Pump System with Smartphone Connectivity for People with Type 1 Diabetes

Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received U.S. Food and Drug Administration (FDA) approval of its MiniMed™ 770G hybrid closed loop system. This newest insulin pump system offers the company’s most advanced SmartGuard™ technology, as featured in the MiniMed™ 670G system, with the added benefits of smartphone connectivity and an expanded age indication down to the age of 2 years old.

REGULATORY FDA

#insulin pump

View Analyst & Ambassador Comments
Go to original news
Sep 28,2020

ABBOTT'S FREESTYLE® LIBRE 3 SYSTEM RECEIVES CE MARK - FEATURES WORLD'S SMALLEST, THINNEST SENSOR WITH BEST-IN-CLASS PERFORMANCE AT THE SAME LOW COST FOR PEOPLE WITH DIABETES

Abbott (NYSE: ABT), the worldwide leader in continuous glucose monitoring (CGM) technology,8 announced today it has secured CE Mark (Conformité Européenne) for its next-generation FreeStyle Libre 3 system, which is now approved for use by people living with diabetes in Europe. The FreeStyle Libre 3 technology provides continuous, real-time glucose readings automatically delivered to smartphones2 every minute, offering unsurpassed 14-day accuracy1 in the smallest and thinnest3 sensor design at the same affordable price7 as previous versions of the device.

REGULATORY CE MARK

#cgm

View Analyst & Ambassador Comments
Go to original news
Nov 11,2020

Brighter has now obtained all outstanding medical device regulatory approvals in the United Arab Emirates

On Monday November 9 Brighter announced that the Company's pioneering diabetes management solution, Actiste®, has received market approval in the UAE, but that some additional regulatory approvals for certain consumables included in the Actiste Service offering were still outstanding.

REGULATORY FDA

#dtx

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