Aug 09,2023 TOP STORY

Nerivio® CE mark indication expanded to preventive and acute treatment of migraine for adolescents and adults

Theranica, a prescribed digital therapeutics company developing advanced neuromodulation devices for migraine and other pain conditions, today announced it received expanded CE mark approval under MDR European regulation for Nerivio® as dual-use therapy for both acute and preventive treatment of migraine for adults and adolescents. The CE mark expansion for Nerivio is a critical milestone to accelerate the availability of the novel, drug-free migraine device into the European market. Nerivio has been available with prescription in the USA since 2020, initially for acute treatment and since April this year also as a preventive treatment.

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Aug 18,2023

Diabetes: M Platform CE Certified as Class I Group of Medical Devices

Sirma Medical Systems' Diabetes: M platform receives CE certification and complies with EU Directive 93/42/EEC and EU Regulation 2017/745 for medical devices, ensuring safety and quality standards.

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Mar 23,2023

Huma receives world’s first and only multi-condition EU MDR Class IIb regulatory approval for its configurable SaMD disease management platform

Huma Therapeutics today announced that it has become the only company in the world to receive EU MDR 2017/745 Class IIb certification for a disease agnostic Software as a Medical Device (SaMD). Achieving Class IIb certification means that the SaMD platform is permitted to monitor patients of all ages with any condition - including infants and in pregnancy - and can connect with a range of external devices, such as heart rate, blood sugar monitors or smart inhalers. In addition to enabling disease self-management by patients, it can also support clinicians to manage serious and critical conditions such as heart failure, COPD exacerbations, surgical recovery, cancer, immunodeficiency, asthma attacks and more.

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Mar 20,2023

Lunit Meets MDR CE Requirements for 3D Breast Tomosynthesis AI Solution

Lunit (KRX:328130.KQ), a leading global provider of AI-powered cancer solutions, today announced that its AI solution for 3D Breast Tomosynthesis (DBT) analysis, Lunit INSIGHT DBT, has met the requirements of the CE marking under Europe's latest Medical Device Regulation (MDR). From May 2024, products without MDR CE certification will be banned from sale in the EU, making it vital for companies to obtain this certification to enter the market. Lunit developed Lunit INSIGHT DBT based on the evaluation that Lunit INSIGHT MMG is one of the most precise AI for commercialized breast screening. Lunit INSIGHT DBT analyzes 3D images from DBT to enable fast and accurate diagnosis of breast cancer.

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Jun 16,2021

Amalgam Rx Receives CE Mark for Basal Insulin Titration

Amalgam Rx, Inc., the leader in connecting healthcare providers and life sciences companies through a SaaS-enabled digital marketplace and product platform, is announcing it has achieved the Conformité Européenne (CE) Mark for its insulin titration application, iSage RxTM and its white-labeled variants. With this CE Mark, iSage Rx’s capacity to support the titration of all basal insulins and enable connectivity to the leading Bluetooth-enabled blood glucose meters from Roche, Lifescan, and Ascensia, is now cleared for the European market.

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Jun 30,2017

Owise Receives CE Mark Class I Medical Device Status

OWise was CE-marked to comply with the European regulatory standards for safety and usage on the 7th of May, 2014. “It is for us of prime importance that patients are well supported throughout their treatment, which is why we wanted to make sure that OWise is safe to use and fit for purpose.” – said Dr. Anne Bruinvels, founder of OWise.

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Feb 09,2023

Ibex's Galen™ Prostate Becomes First Standalone AI-Powered Cancer Diagnostics Solution to Obtain CE Mark Under the IVDR

Ibex Medical Analytics today announced that Galen™ Prostate is now CE marked under the In Vitro Diagnostic Medical Devices Regulation (IVDR) for supporting pathologists in primary diagnosis of prostate biopsies. Galen Prostate is the first standalone AI-based cancer diagnostics product of its kind certified under the IVDR. IVDR is the new regulatory standard set by the European Union, replacing the previous In Vitro Diagnostic Medical Device Directive (IVDD). During 2023, Ibex plans to migrate additional products, including its Galen Breast and Galen Gastric solutions, under the IVDR certificate. Galen Prostate uses AI to analyze biopsies ahead of pathologists' review, providing them with diagnostic insights to guide their diagnosis.

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Feb 20,2023

Innovation Zed Announces CE Mark of New Technology InsulCheck DOSE: An Add-on Device That Automatically Logs the Time and Dialled Dosage for Insulin Pen Users

Innovation Zed, an Irish R&D company specialising in the design, development and manufacturing of medical technologies, announced today it has secured a CE Mark for the InsulCheck DOSE add-on device. InsulCheck DOSE is a single-unit add-on device for pen injectors that automatically captures dose value dialled, injection event time stamp and temperature as well as mounting and unmounting events. With InsulCheck DOSE, real-time injection event data are logged and sent automatically to a compatible display device.

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Jun 16,2021

Amalgam Rx Receives CE Mark for Basal Insulin Titration

Amalgam Rx, Inc., the leader in connecting healthcare providers and life sciences companies through a SaaS-enabled digital marketplace and product platform, is announcing it has achieved the Conformité Européenne (CE) Mark for its insulin titration application, iSage RxTM and its white-labeled variants. The CE Mark demonstrates Amalgam's commitment to EU standards for quality management, safety, and performance as defined in the Medical Devices Directive 93/42/EEC.

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Jun 23,2020

Akili Announces CE Mark Approval of EndeavorRx™ Digital Treatment for Children with ADHD

Akili today announced that it has received Conformité Européenne (CE) Mark certification for EndeavorRx (AKL-T01), as a prescription-only digital therapeutic software intended for the treatment of attention and inhibitory control deficits in pediatric patients with Attention Deficit Hyperactivity Disorder (ADHD). ADHD is one of the most common psychiatric disorders in childhood and nearly 5 percent of children in Europe are diagnosed with the disorder.

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