How Medtech Companies are Unlocking the Potential of Latin America in Clinical Research
Medtech startups' challenges in the medical device industry in the US are multifaceted, ranging from regulatory hurdles to limited financial resources and prolonged subject recruitment timelines. US Medtech companies face professionalism, language barriers, fragmentation of resources, and lack of CRO corporate structures in Latin America. This impedes Latin American hospitals from having seamless communication and collaboration with American clinical trial clients, particularly in the medical device first-in-human clinical trial industry. These factors underscore the urgent need for a solution-driven approach to bridge the gap between innovation and execution in Latin America.
eyeFlow, Inc. Obtains Colombia Approval for its Pilot Clinical Study
On February 14, 2024, INVIMA, Colombia's regulatory agency, approved a pilot study by eyeFlow, Inc. at one research center in Barranquilla. This pilot clinical trial aims to recruit 60 subjects in Colombia and will last approximately 18 months.
i-Lumen Scientific, Inc. Obtains Colombia Approval for its i-Sight 2 Clinical Study
On January 17, 2024, Colombia's regulatory agency, INVIMA, approved i-Lumen Scientific, Inc.'s i-Sight 2 study at two research centers, one in Medellín and another in Cali. The i-Sight clinical trial seeks to recruit up to 75 subjects in Colombia and will last about 27 months.
3ive Labs Obtains Colombia Approval for its BIPASS-AKI 2 Study
On November 15, 2023, INVIMA, Colombia's regulatory agency, approved the BIPASS-AKI-2 early feasibility study by 3ive Labs, LLC (aka “Roivios™), with its JuxtaFlow ® (RAD) renal assist device at two research centers, one in Barranquilla, and the other one in Bucaramanga. This early feasibility study aims to recruit up to 40 subjects in Colombia and will last approximately 30 months.
Imperative Care Obtains Colombia Approval for its ADVANCE First-In-Human study
On September 28, 2023, INVIMA, the regulatory agency of Colombia, approved Imperative Care, Inc.'s ADVANCE first-in-human study, which will be conducted at one research center in Cartagena. The ADVANCE study aims to recruit up to 15 subjects from Colombia and will last for approximately five years.
Cook Medical Treats First Patient in First-In-Human Clinical Trial for Venous Valve
Cook Medical announces the first patient treated in a clinical study to evaluate a new venous valve for treating chronic venous insufficiency. The patient was treated by Dr. Mauricio Alviar, vascular surgeon and principal investigator of Clinica de la Costa in Barranquilla, Colombia.
