Long COVID-19 Survivors Report Effects Following Recovery
According to a systematic review consisting of 57 studies and including 250,000+ patients, more than 50% patients with long COVID (persistent postacute sequelae of COVID-19 or PASC) described feeling effects of COVID beyond six months after recovery. The results...
Migraines: Canada Gives Regulatory Approval for ElectroCore
electroCore, a leading bioelectronic medicine company, have received a revised Medical Device License (MDL) from Health Canada to extend its labelling of electroCore’s gammaCore nVNS to include the acute and preventive treatment of migraine in adolescents (aged 12 -...
Breast Cancer: FDA Approves Eli Lilly Verzenio Inhibitor
Eli Lilly and Company has received FDA approval from the US FDA (Food and Drug Administration) for the first and only CDK4/6 inhibitor for a specific group of people with Breast Cancer. Verzenio, abemaciclib, aims to treat adult patients with hormone receptor-positive...
Genematrix NeoPlex HPV 29 Detection Gains European CE-IVD
Genematrix, known for their real-time PCR based molecular diagnostics, have announced that NeoPlex HPV29 Detection has gained European Medical Device Certification (CE-IVD). Designed to simultaneously diagnose 29 genotypes of human papillomavirus (HPV - a key...
Medtronic Hugo Robotic Surgery System Granted European CE Mark
A global leader in medical technology, Medtronic, has been granted CE (Conformité Européenne) Mark for the Hugo™ robotic surgery (RAS) system, giving the green light for sales of the system in Europe. The approval has been given for urologic and gynecologic procedures...
FDA Approves ChemoCentryx Drug for Rare Autoimmune Disease
ChemoCentryx has received US FDA (Food and Drug Administration) approval for their drug, avacopan, to treat the rare, fatal autoimmune disease, antineutrophil cytoplasmic antibody (ANCA)-associated vasculitides (AAV). The oral drug, brand name Tavneos, will help those...
ABOUT US
CSOFT Health Sciences has over 15 years of experience providing end-to-end translation and localization solutions for all stages of the product life cycle, from pre-clinical to post-launch. We also specialize in China market access consulting services, Asian regulatory and eCTD submissions. Our operation is compliant with ISO 17100 and certified by BSI in ISO 9001:2015 and ISO 13485:2016, providing customized solutions to meet the rigorous regulatory requirements in global submission. For more information, please visit: www.csoftintl.com