Oct 12, 2021 | News, Regulatory
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...
Aug 26, 2021 | Health, Medical Translation
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...
Aug 12, 2021 | Health, Regulatory
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...
Aug 12, 2021 | News, Regulatory
Syntr Health Technologies has been granted clearance from the US FDA (Food and Drug Administration) for their SyntrFuge System for surgical use when transferring a patient’s adipose (fat) tissue. Syntr Health Technologies, a medical device company that focuses on the...
