May 26,2021

One Drop Receives CE Mark, Launches Data-Driven Insights for People Managing High Blood Pressure

One Drop, a leader in precision health solutions for people living with chronic conditions, today announced it has received the Conformité Européenne (CE) Mark for its Blood Pressure Trend and Analysis Engine-1 to generate blood pressure (BP) insights. As part of the One Drop Digital Membership, consumer and employer members worldwide can now receive in-app messages with blood pressure trends, behavioral reinforcements, and alerts for hypertensive crises.

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Mar 31,2022

Optellum wins CE mark for AI-powered early lung cancer diagnostic tech

Oxford, England-based Optellum designed the Virtual Nodule Clinic as a clinical decision-support tool for helping clinicians identify and track at-risk patients who present suspicious lung nodules that may or may not be cancerous. The platform received FDA 510(k) clearance in March 2021.

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May 27,2022

DoMore Diagnostics wins CE mark for AI algorithm that predicts colorectal cancer outcomes

DoMore Diagnostics announced that it received CE mark approval in Europe for its Histotype Px Colorectal deep learning algorithm. Oslo, Norway-based DoMore designed its Histotype Px Colorectal deep learning algorithm to predict colorectal cancer patient outcomes based on analysis of digital histology images.

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May 20,2021

The Vinehealth Cancer Platform receives medical device CE mark certification

Vinehealth has received a Class 1 Medical Device CE mark for its Vinehealth mobile app for cancer patients and VinehealthPRO web application for clinicians. Vinehealth conforms to the requirements of the Medical Devices Directive 93/42/EEC. The Directive outlines safety and performance requirements for medical devices in the UK & EU.

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May 12,2021

Voluntis receives CE Mark for new version of Oleena with expanded clinical intelligence

Voluntis today announced that it has received the CE mark for a new version of Oleena featuring expanded clinical intelligence. Oleena is Voluntis’ proprietary digital therapeutic that supports patients in the self-management of their symptoms in combination with a wide range of cancer treatments, while allowing healthcare teams to remotely monitor the progress of the disease.

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Mar 04,2020

AI-Pathway Companion Prostate Cancer from Siemens Healthineers Approved for Use in Europe as Medical Device

AI-Pathway Companion Prostate Cancer(2), a digital companion from Siemens Healthineers to support clinical decision-making, has recently received the CE mark for use in the clinical pathway of prostate cancer, the second most common cancer (after lung cancer) affecting males worldwide.(3) The conformity mark confirms that the application AI-Pathway Companion Prostate Cancer is CE-compliant in accordance with Directive 93/42/EEC and can therefore be marketed in the EU as a medical device.

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Nov 16,2020

Voluntis receives CE Mark for Oleena, key milestone to the future commercialization of its digital therapeutic for oncology

Voluntis (Euronext Paris, Ticker: VTX – ISIN: FR0004183960), a leader in digital therapeutics, today announced that it has received the CE mark for Oleena. This is a key first step ahead of the commercialization of its oncology solutions in the European Union.

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Dec 14,2020

AI developer Paige scores CE marks in breast, prostate cancers

Digital pathology developer Paige has received two European approvals for its artificial-intelligence-powered diagnostic platforms in breast and prostate cancers. One CE mark covers breast cancer detection software that automatically highlights suspicious areas on slides of biopsied breast tissue for further review, while a second greenlights software to help rate prostate tumor samples, deliver a prognosis and guide treatment planning.

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Oct 20,2014

Philips Digital Pathology Solution Receives CE Mark for Diagnosis to Help Advance Oncology Diagnosis

Royal Philips (NYSE: PHG, AEX: PHIA) has acquired the CE mark for diagnostic use of its Philips Digital Pathology Solution. European pathologists will now be able to use the full digital solution as an aid in diagnosis for routine pathology, such as primary diagnosis of oncology.

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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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