Category: CE Mark

Medtronic’s Radial Artery Catheter Device Receives CE Mark Approval for the Treatment of Neurovascular Diseases

Shots: The company has received CE Mark for its radial artery access portfolio including Rist 079 radial access guide catheter and Rist radial access selective catheter to treat patients with stroke, brain aneurysms & other neurovascular conditions Additionally, both device is designed to introduce interventional devices into peripheral, coronary & neuro vasculature. The devices are […]

PharmaShots Interview: Abbott’s Michael Dale Shares Insight on the CE Mark for the Next-Generation Navitor TAVI System

In an interview with PharmaShots, Michael Dale, Senior Vice President of the Structural Heart division at Abbott shared his views on the Navitor’s approval in the EU for patients with severe aortic stenosis who are at high or extreme surgical risk for open-heart surgery. Shots: Abbott has received CE Mark approval for its latest-generation transcatheter […]

Roche’s SARS-CoV-2 Antigen Test Receives CE mark For Self Testing of COVID-19 at Home

Shots: Roche received a CE mark for its SARS-CoV-2 Ag self-test nasal at home setting for COVID 19. The test will be available in countries accepting the CE mark The early version of the test is available in the EU under special approval pathways since Feb, 2021. The test can be performed by individuals using […]

Roche Receives the US FDA’s EUA for cobas SARS-CoV-2 Test to Suspect COVID-19

Shots: Roche’s cobas SARS-CoV-2 test to be use on high-throughput cobas 6800/8800 systems has received the US FDA’s EUA for testing individuals without symptoms or reasons to control the spread of COVID-19 The authorization expands SARS-CoV-2 testing to include people without symptoms and applies to pooled samples containing up to and including 6 individual samples […]

Abbott Receives CE Mark for Next-Generation Navitor TAVI System to Treat Aortic Stenosis

Shots: Abbott has received CE Mark for Navitor making the minimally invasive device available for people in Europe with severe aortic stenosis who are at high or extreme surgical risk Navitor uses Abbott’s FlexNav delivery system along with a unique design for preventing blood leaking around the valve to provide a less invasive alternative to […]

Empatica’s Aura System Receives European CE Mark for Detecting Early Symptoms of COVID-19 Using Wearables

Shots: Empatica received its CE mark for Aura system as a class lla medical device, along with its remote health monitoring platform (Care) meet safety and performance requirements in the EU Aura system detects and alerts to respiratory infections including COVID-19, before the visible appearance of symptoms. The system has demonstrated a sensitivity of 0.94 […]

Empatica’s Aura System Receives European CE Mark for Detecting Early Symptoms of COVID-19 Using Wearables

Abbott’s Panbio Rapid Antigen Test Receives CE Mark for Mass COVID-19 Screening

Shots: Abbott received a CE mark for asymptomatic testing and self-swabbing using its Panbio COVID-19 Ag test to detect SARS-CoV-2. Abbott has shipped 200M test to 120 countries globally The test is approved with a patient-friendly and minimally invasive nasal swab, i.e. patients can self-administer sample collection under an HCP’s supervision and delivers results in […]

Abbott’s COVID-19 IgG Quantitative Antibody Blood Test Receives CE Mark

Shots: Abbott received CE Mark for its new quantitative SARS-CoV-2 IgG lab-based serology test. The test measures levels of IgG Abs to help in the evaluation of a person’s immune response The study to determines the clinical performance of Abbott’s SARS-CoV-2 IgG II Quant test on its Alinity i instrument showed that it had 99.60% […]

Abbott to Launch its Cardiac Mapping Platform in Europe and Australia

Shots: The company has received CE mark in EU and approval in Australia for its new EnSite X EP system which offers the option to navigate the cardiac anatomy in two different ways on one platform. The system can create a 3D model of the patient’s cardiac anatomy in real time and will enable physicians […]