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Results For "CE-Mark"

74 News Found

Roche receives CE Mark for its AI-enabled continuous glucose monitoring solution
News | July 10, 2024

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

The built-in AI-trained algorithms will empower users to proactively intervene when their glucose levels require attention and before a complication can even occur


Abbott wins CE mark for dual-chamber leadless pacemaker
News | June 11, 2024

Abbott wins CE mark for dual-chamber leadless pacemaker

Abbott's first-of-its-kind i2i technology enables synchronized communication between two leadless pacemakers


Roche obtains CE Mark for first companion diagnostic to identify patients with HER2-low metastatic breast cancer
Diagnostic Center | April 11, 2024

Roche obtains CE Mark for first companion diagnostic to identify patients with HER2-low metastatic breast cancer

Approximately half of all patients with metastatic breast cancer (mBC) express low levels of HER2


OvaCis rapid test to detect ovarian cancer gets CE mark
Drug Approval | May 12, 2022

OvaCis rapid test to detect ovarian cancer gets CE mark

Revolutionary ovarian cancer rapid test available Q4 2022


Qvella FAST System and FAST-PBC get CE marked and USFDA listed
Biotech | April 22, 2022

Qvella FAST System and FAST-PBC get CE marked and USFDA listed

With the commercialization of Qvella technology for Positive Blood Culture (PBC) processing, healthcare facilities can now get results up to 24 hours faster than current methods


Sense receives CE marking for Veros Covid-19 instrument-free molecular test
Medical Device | March 08, 2022

Sense receives CE marking for Veros Covid-19 instrument-free molecular test

Sense anticipates launching Veros Covid-19 in Europe this quarter, initially in Ireland, Benelux and the Nordic regions


Indica Labs receive CE Mark for its HALO AP
Medical Device | January 10, 2022

Indica Labs receive CE Mark for its HALO AP

The HALO AP platform was developed by Indica Labs to address the specific needs of anatomic pathology labs by supporting a wide range of tissue-based workflows, including primary diagnosis, secondary consults, tumour boards, clinical trials, synoptic reporting, quantitative analytics, and AI


Algorithmic Biologics receives CE mark for Tapestry platform
Startup | December 10, 2021

Algorithmic Biologics receives CE mark for Tapestry platform

The platform’s technology works as a compression algorithm for molecular testing


Roche to launch SARS-CoV-2 and flu A/B Rapid Antigen Test in countries accepting the CE mark
Medical Device | December 06, 2021

Roche to launch SARS-CoV-2 and flu A/B Rapid Antigen Test in countries accepting the CE mark

The combination rapid antigen test quickly differentiates between SARS-CoV-2 and influenza viruses A and B infections, with results ready in less than 30 minutes, allowing informed decisions on patient and pandemic management decisions


Medtronic’s robotic-assisted surgery system receives European CE mark
Medical Device | October 12, 2021

Medtronic’s robotic-assisted surgery system receives European CE mark

In Western Europe, about 2% of procedures are done robotically while the majority, approximately 65%, are open surgery