Nov 16,2017

Voluntis gets FDA clearance to add last two basal insulins to app

Medical device software company Voluntis has received an updated FDA clearance (as well as an updated CE mark) for its Insulia app , a "digital companion" app for people with Type 2 diabetes. Insulia offers realtime basal insulin dose coaching, and the new clearance makes the app usable with two additional brands of insulin: Basaglar and Tresiba. The app had already worked for users of Lantus, Levemir, and Toujeo.

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Mar 15,2016

Nemaura Medical Announces receipt of notification of CE Approval for its sugarBEAT® Continuous Glucose Monitoring System

Nemaura Medical Inc. (OTC BB: NMRD),(“Nemaura”), a medical device company developing a minimally invasive wireless continuous glucose monitoring (“CGM”) system known as sugarBEAT®, announced today that it has received notification of CE Approval for its sugarBEAT® system from its European Notified Body.

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May 11,2016

Senseonics receives CE Mark for implantable continuous glucose monitoring system

Senseonics, a Germantown, Maryland-based company working on a longterm implantable continuous glucose monitor, has received a CE Mark for its Eversense Continuous Glucose Monitoring (CGM) System.

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May 17,2016

ASCENSIA DIABETES CARE RECEIVES CE MARK FOR THE STATE-OF-THE-ART CONTOUR™ NEXT ONE AND CONTOUR™ PLUS ONE BLOOD GLUCOSE MONITORING SYSTEMS

Today, Ascensia Diabetes Care announced that it has received CE Mark (Conformité Européenne) for the new CONTOUR™ NEXT ONE and CONTOUR™ PLUS ONE blood glucose monitoring systems, the next exciting development in the evolution of self-monitoring of blood glucose for people with diabetes.

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Jul 19,2016

Medtronic gets CE Mark for smartphone-connected CGM

Medtronic has received a CE Mark for its Guardian Connect mobile continuous glucose monitor (CGM) and app. The company will begin selling the system in select countries in Europe, Asia, and Latin America in Q2 2017 and expects to receive FDA clearance to launch the device in the US around that same time.

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Jul 28,2016

Lilly-backed smartphone-enabled insulin pen gets FDA nod

Companion Medical, a stealthy San Diego-based company that received funding last year from Eli Lilly and Company, has received FDA 510(k) clearance for its Bluetooth-connected smart insulin pen and associated mobile app, called InPen.

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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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