Sep 19,2022

BIOCORP announces the CE marking of SoloSmart®, a medical accessory for SANOFI Solostar® pens on the occasion of EASD

BIOCORP, a French company specialized in the design, development and production of innovative medical devices, and SANOFI today announced the completion of the development of SoloSmart®, at the opening of the EASD (European Association for the Study of Diabetes) annual meeting in Stockholm, Sweden. SoloSmart® is fully compatible with the SoloStar® injection pens of the pharmaceutical group.

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Sep 20,2022

Insulet Announces CE Mark Approval for Omnipod® 5 Automated Insulin Delivery System

Insulet Corporation, the global leader in tubeless insulin pump technology with its Omnipod® brand of products, today announced it has received CE marking under the European Medical Device Regulation for its Omnipod 5 Automated Insulin Delivery System (Omnipod 5) for individuals aged two years and older with type 1 diabetes.

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Sep 20,2022

Insulet wins CE Mark for Omnipod 5 for children 2 and up

Insulet can now market Omnipod 5 in Europe for individuals 2 years and older with type 1 diabetes. Acton, Massachusetts–based Insulet said it represents the first CE-marked tubeless hybrid closed loop system

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Sep 22,2022

Better Therapeutics submits FDA de novo request for type 2 diabetes treatment

Better Therapeutics announced today that it submitted a de novo classification request to the FDA for its BT-001 technology.

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Jan 24,2019

BD Launches Ergonomic Pen Needle Technology to Help Optimize Injection Technique

BD (Becton, Dickinson and Company) a leading global medical technology company, announced the U.S. Food and Drug Administration 510(k) clearance of its second generation BD Nano(TM) pen needle, designed for more reliable subcutaneous injection depth.

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Feb 19,2019

FDA grants De Novo clearance to interoperable insulin pump

The Tandem Diabetes Care t:Slim X2 insulin pump was reviewed through the De Novo premarket review pathway, making it the first of a new medical device category called Alternate Controller Enabled (ACE) infusion pumps. Intended for use by both adults and children with diabetes, the digital device automatically receives insulin dosing commands from a diabetes management device once connected, or can independently infuse insulin when it is on its own.

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Feb 25,2019

Hygieia's cloud-based insulin titration app wins 510(k) clearance

Earlier this month, Hygieia’s d-Nav Insulin Guidance Service — an app that titrates insulin doses for individual Type 2 diabetes patients, regardless of their regimen type — received 510(k) clearance from the FDA.

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Feb 14,2019

t:slim X2 Insulin Pump First to Receive New ACE Pump Classification by FDA

Tandem Diabetes Care, Inc., a leading insulin delivery and diabetes technology company, today announced that the U.S. Food and Drug Administration (FDA) has classified the t:slim X2™ insulin pump as the first in a new device category called Alternate Controller Enabled Infusion Pumps (ACE pumps). Along with this authorization, the FDA is establishing criteria, called special controls, which outline requirements for assuring the accuracy, reliability, cybersecurity and clinical relevance of ACE pumps, as well as describe the type of studies and data required to demonstrate acceptable pump performance. The approved indication for the t:slim X2 pump states that the pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices.

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Feb 19,2019

Medtronic Receives FDA Breakthrough Designation for Developing Personalized Closed Loop Insulin Pump System for Diabetes Management

Medtronic plc, the global leader in medical technology, today announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its Personalized Closed Loop (PCL) insulin pump system, currently in development. The PCL technology is designed to automate insulin delivery in a way that is real-time, personalized and adapts to the user. The system will also provide insights and predictive diagnostics unique to the individual, with a goal of dramatically simplifying diabetes management for the patient. The recent acquisition of Nutrino Health and their expertise in nutrition data science will play a key role in the accelerated development of this breakthrough technology.

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Mar 06,2019

Voluntis receives CE Mark to add NPH/isophane to Insulia

Today, Voluntis announced that it had obtained the CE mark for the new version of Insulia that integrates intermediate-acting neutral protamine Hagedorn (NPH) insulin, also known as isophane insulin. Insulia is the first digital therapeutic with regulatory clearance to provide automated titration recommendations for all types of basal insulin, including NPH insulin as well as all first and second generation long-acting basal insulin analogs.

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