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...
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...
CSOFT Health Sciences sat down with Dr. Vladimir Misik, board member of leading European CRO, SanaClis, as well as Partner and Founder of LongTaal, and Partner and Co-founder of VIARES Academy, in our newest podcast episode of Coffee & Conversations to evaluate...
Following our last LATAM series blog post which focused on Venezuela, this week we are focusing on Colombia’s medical device regulatory pathway. In 2018, over 80% of Colombia’s medical device market relied on imported devices; from a monetary perspective, this equals...
Venezuela is the third largest medical device market in Latin America, following Brazil and Mexico, which makes understanding Venezuela’s medical device regulatory pathway crucial for MedTech companies expanding into Latin America (LATAM). Somewhat similar...
Our LATAM series continues this week with Mexico’s medical device regulatory pathway. In 2019, Mexico’s import medical device market was estimated to be approximately $5.7 billion USD. In 2020, that number increased to $6.5 billion USD. With demand for medical devices...
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