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Results For "CE-Mark"

90 News Found

Evonik invests in start-up to improve patient recovery after open-chest surgery
Startup | February 18, 2022

Evonik invests in start-up to improve patient recovery after open-chest surgery

Evonik invests in start-up to improve patient recovery after open-chest surgery


Glenmark launches nasal spray to treat Covid-19
News | February 09, 2022

Glenmark launches nasal spray to treat Covid-19

Glenmark received manufacturing and marketing approval from DCGI for Nitric Oxide Nasal Spray (NONS) as part of accelerated approval process


Lay Sciences launch ImmynlgY, an oral antibody to neutralize Covid-19
Biotech | February 07, 2022

Lay Sciences launch ImmynlgY, an oral antibody to neutralize Covid-19

ImmunIgY, has been developed by ReaGene Biosciences, Kyntox Bio and ProdigY, and is an antibody-containing beverage that can potentially prevent viral entry, regardless of vaccination or infection status


LumiraDx Lab Covid-19 Antigen test detects the Omicron variant
Medical Device | January 14, 2022

LumiraDx Lab Covid-19 Antigen test detects the Omicron variant

In-house wet testing with live Omicron virus demonstrated that the Antigen test detects the Omicron variant with comparable sensitivity to other variants


Transcat acquires Tangent Labs for US $ 9 million
Medical Device | January 04, 2022

Transcat acquires Tangent Labs for US $ 9 million

Tangent offers ISO/IEC 17025-accredited calibrations and has labs located in both Indianapolis and Huntsville, Alabama


U.S. FDA grants breakthrough designation to Datar’s blood test to detect breast cancer
Drug Approval | November 20, 2021

U.S. FDA grants breakthrough designation to Datar’s blood test to detect breast cancer

It is the first blood test able to detect early-stage Breast Cancer with high accuracy in women above the age of 40 years


Roche launches cobas 5800, a new molecular diagnostics system
Digitisation | November 18, 2021

Roche launches cobas 5800, a new molecular diagnostics system

The system is a compact new addition to the Roche Molecular portfolio, providing efficiency, simplicity and timely results to laboratories of all sizes.


Sage Therapeutics and Biogen plan to submit a New Drug Application (NDA) for zuranolone
Biotech | October 21, 2021

Sage Therapeutics and Biogen plan to submit a New Drug Application (NDA) for zuranolone

Following the pre-NDA meeting with the U.S. FDA, the companies confirmed the current efficacy and safety databases are expected to be adequate for filing with confirmed pathways for MDD and PPD


India approves LumiraDX’s Antigen test kit
Medical Device | October 21, 2021

India approves LumiraDX’s Antigen test kit

The test combines sensitivity with speed and is designed to be used in health care settings to aid with rapid diagnosis of Covid-19


U.S. FDA clears Venclose Maven to treat incompetent perforator veins
Medical Device | October 07, 2021

U.S. FDA clears Venclose Maven to treat incompetent perforator veins

Next-generation radiofrequency catheter offers first thermal ablation perforator treatment advancement in over 10 years