Jul 09,2024 TOP STORY

Roche receives CE Mark for its AI-enabled continuous glucose monitoring solution

Roche announced today that it has received the CE Mark for its Accu-Chek SmartGuide continuous glucose monitoring (CGM) solution with 14-day wear time. This significant milestone paves the way for the solution to be made available to people living with type 1 and type 2 diabetes over the age of 18 on flexible insulin therapy. Every five minutes, the Accu-Chek SmartGuide CGM sensor sends glucose values measured in real time to the Accu-Chek SmartGuide app. The Accu-Chek SmartGuide Predict app then utilises those glucose values and other available information to detect glucose patterns and predict future glucose levels. Its integrated AI-enabled predictive algorithms indicate hypoglycaemia risk within the next 30 minutes, continuously forecast how glucose levels will develop within the next two hours, and estimate the risk of nocturnal hypoglycaemia. The Accu-Chek SmartGuide solution seamlessly integrates with the Accu-Chek Care platform, offering healthcare professionals access to comprehensive therapy-relevant data provided by the CGM solution.

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Jun 26,2024

Boston Scientific's DBS software gains CE as Parkinson's treatments advance

Boston Scientific has received the CE mark for its Vercise Neural Navigator 5 software, part of its Deep Brain Stimulation (DBS) system for treating Parkinson's disease. This milestone highlights the trend towards integrating advanced technology and AI in managing neurological conditions, in line with the FDA's call for innovation in Parkinson's treatments. The neurological devices market, valued at $12.5 billion in 2023, is projected to grow to $20.9 billion by 2033, driven by the demand for advanced diagnostic and monitoring tools. Innovations like Boston Scientific’s software and wearable technologies, such as those utilizing Apple Watch data, are enhancing therapeutic interventions and promoting a comprehensive approach to disease management. This shift towards high-tech solutions marks a significant advancement in personalized and effective neurological care.

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Mar 12,2024

Welldoc Announces CE Mark Certification

Welldoc announced that its flagship BlueStar mobile app has received CE mark certification as a Class IIa medical device under the European Union Medical Device Regulation (EU-MDR). This enables the company and their strategic partners to advance digital health solutions in the EU, addressing chronic condition needs that are rising globally. The announcement builds upon Welldoc’s existing 11 FDA clearances for type 1 and type 2 diabetes management capabilities, including advanced insulin dosing calculators. This milestone underscores the company’s continued commitment to the highest standards of quality, while also demonstrating extensive leadership in AI-based digital health solutions. 

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Dec 18,2023

NuvoAir’s Air Next Spirometer is Now EU MDR Certified

NuvoAir has received an updated CE mark certification for its proprietary Air Next spirometer, complying with the new European legislation for medical devices. NuvoAir’s long-standing CE mark signified compliance with the Medical Device Directive (MDD). However, to ensure more stringent regulation of medical devices and better safeguard patients, MDD was replaced by the European Medical Device Regulation (EU MDR). In addition to EU MDR, NuvoAir holds the ISO 13485:2016 certification.

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Feb 07,2024

Insulet Announces CE Mark Approval of Omnipod® 5 Integration with Abbott FreeStyle Libre 2 Plus Sensor

Insulet Corporation announced it has received CE mark approval under the European Medical Device Regulation for the added compatibility of the Abbott FreeStyle Libre 2 Plus sensor with Insulet’s Omnipod 5 Automated Insulin Delivery System for individuals aged two years and older with type 1 diabetes. Insulet expects Omnipod 5 integration with the Abbott FreeStyle Libre 2 Plus sensor to be available first in the United Kingdom and Netherlands in a phased launch in the first half of 2024, with additional markets to follow.

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Jan 08,2024 TOP STORY

Medtronic Diabetes announces the approval for MiniMed 780G System with Simplera Sync disposable, all-in-one sensor

Medtronic announced CE Mark approval for the MiniMed 780G system with Simplera Sync, a disposable CGM requiring. Simplera Sync features a two-step insertion process and is half the size of previous Medtronic sensors. The MiniMed 780G system with Simplera Sync sensor will be available in Europe via limited release in spring 2024. Medtronic will begin the phased commercial launch in Europe in the summer of 2024. Today, the MiniMed 780G system can be used with the Guardian 4 sensor. The MiniMed 780G system is an advanced insulin delivery system, automatically adjusting and correcting glucose levels every 5 minutes, and features with a Meal Detection feature to reduce post-meal hyperglychemia. The system with Simplera Sync sensor is not approved by the FDA and is limited to investigational use in the U.S. Simplera Sync sensor is designed to leverage Medtronic's advanced AID algorithm as part of its MiniMed 780G system while having a similar look and feel as the Simplera CGM which is for integrated use with the InPen smart insulin pen.

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Nov 02,2023 TOP STORY

Sibionics wins CE mark for GS1 CGM System

Chinese company Sibionics has obtained a CE Mark for its GS1 continuous glucose monitoring system (CGM), a wearable device that uses an under-the-skin sensor to measure glucose levels in real-time, transmitting the information to a linked handset or mobile phone. The GS1 CGM offers users 14 days of continuous glucose monitoring without the need for frequent calibration. It allows users to transmit glucose data to monitoring devices or mobile apps and generate professional reports.  An additional feature of the system supports data sharing with friends and family and integrates the ProView remote access platform for healthcare providers to monitor and intervene. The GS1 CGM received marketing approval in China in 2021, and the company claims that it is the first blood-glucose meter without the need for finger blood calibration. 

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Oct 23,2023 TOP STORY

Lucida Medical's New AI Software for Prostate Cancer Diagnosis Received CE Mark Certification

Lucida Medical Ltd, a Cambridge-based start-up company dedicated to improving cancer diagnosis, has announced Class IIb CE certification for its AI-based prostate cancer detection software, Prostate Intelligence™ (Pi™). Built with leading clinicians and UK NHS hospitals, the CE mark means the software can now benefit patients across Europe. Data presented at the European Society for Urogenital Radiology (ESUR) in September 2023 indicated that Pi™ could help cut undetected cancers to 6% while also reducing avoidable biopsies to 43%. Using AI, Pi™ analyses the MRI and is fully integrated into the radiologist's workflow, targeting key issues of variability, radiologist time, and diagnostic accuracy in prostate cancer. Specifically, Pi™ is intended to be used by radiologists to assess and report prostate MRI studies, by automatically producing 3D segmentations, volumes and risk scores. The company plans to make Pi™ commercially available in the UK and EU in Q1, 2024. Pi™ is not for sale in the US.

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Nov 21,2022

Lunit Becomes the First Medical Software Company in Asia-Pacific to Become MDR CE and UKCA Certified

Lunit (KRX: 328130.KQ), a global provider of AI-powered cancer solutions, today announced that its AI solution suite for radiology, Lunit INSIGHT, has received the CE marking under Europe’s newest Medical Device Regulation (MDR). The Lunit INSIGHT product line also received the UK Conformity Assessed (UKCA) marking, obtaining commercial approval across both the UK and Europe. Among the Lunit INSIGHT suite, two products received the MDR CE and UKCA certifications: Lunit INSIGHT CXR, an AI solution for chest x-ray analysis, and Lunit INSIGHT MMG, an AI solution for mammography analysis.

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Sep 21,2023 TOP STORY

Medtronic Diabetes announces CE Mark for new Simplera™ CGM with disposable all-in-one design

Medtronic today announced CE Mark approval for its new all-in-one, disposable Simplera continuous glucose monitor (CGM) featuring a simple, two-step insertion process. The company's newest no-fingerstick sensor does not require over tape and is seamlessly integrated with the InPen smart insulin pen, which provides real-time dosing guidance. Medtronic will begin a phased launch at the European Association for the Study of Diabetes (EASD) 59th Annual Meeting in Hamburg, Germany on Oct. 2-6, 2023. "Despite the rapid adoption of CGM over the past decade, less than 30% of individuals on MDI therapy using a CGM achieve glycemic targets — highlighting a significant unmet need. We're excited to help more people to reach their goals with our advanced algorithm in InPen™ powered by our smallest and most comfortable CGM to-date," said Que Dallara, EVP and President, Medtronic Diabetes. Simplera is indicated for ages 2+ and is not approved by the FDA. Medtronic's automated insulin delivery (AID) system integrated with this next-generation sensor is currently under review for CE Mark and is not commercially available in the U.S. or in Europe.

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