Axoft, a cutting-edge neurotechnology company, has successfully completed the first four human implantations of its revolutionary ultra-soft brain-computer interface (iBCI) at The Panama Clinic. This milestone—achieved just 2.5 years after seed funding—demonstrates the safety and functionality of Axoft’s bio-inspired Fleuron™ material, which is 10,000 times softer than current iBCI materials. Enabled by a strategic partnership with bioaccess®, Latin America’s only Medtech-focused CRO, the study underscores the region’s potential for accelerated, cost-effective clinical development. The breakthrough paves the way for new possibilities in treating neurological disorders while showcasing Latin America as a strategic hub for early-stage Medtech trials.
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Global Clinical Research Accreditation Launches in Latin America IAOCR and GCSA have officially launched their gold-standard clinical research certification programs in Latin America through iaocramericas.com. For the first time, regional sites, professionals, and sponsors can access globally recognized accreditations to improve trial quality, reduce risk, and attract international partners. The initiative is backed by regional experts, including CRO bioaccess®, and aims to elevate Latin America's role in global clinical trials.
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Mexico Introduces Fast-Track Approval Pathway for Phase III Clinical Trials via International Regulatory Reliance COFEPRIS has launched a new "Regulatory Reliance" pathway that will significantly accelerate approval timelines for Phase III clinical trials in Mexico—reducing review time to just 45 calendar days for studies already approved by the FDA, EMA, MHRA, or Health Canada. Effective 60 business days after its March 18, 2025 publication, this digital-only process positions Mexico as a competitive hub for international clinical research while maintaining strict safety and ethical oversight. The pathway is limited to non-adaptive Phase III trials in key therapeutic areas and excludes products with safety alerts. This regulatory innovation aligns with global trends and supports faster access to new therapies for patients in Mexico.
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On March 10, 2025, Care Access announced the acquisition of CEMEC, a leading Brazilian clinical research center, strengthening its footprint in Latin America’s growing clinical trials market. This move enhances local research capacity by combining CEMEC’s experience—over 100 trials in 18 therapeutic areas—with Care Access’s innovative decentralized trial model. The expansion includes mobile clinics, new research sites across Brazil and Argentina, and the launch of the Future of Medicine program, improving access to clinical trials in underserved communities. This strategic acquisition positions Latin America as a key destination for global clinical research.
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AtaCor Medical has selected Paraguay for a pivotal clinical study of its next-generation Extravascular Implantable Cardioverter Defibrillator (EV-ICD), reinforcing Latin America's position as a global hub for first-in-human Medtech trials. This innovative technology delivers shock and pacing therapies without placing leads inside the heart, offering a safer alternative for patients with tachyarrhythmias. Paraguay was chosen for its efficient regulatory environment, cost-effectiveness, and diverse patient population, making it ideal for early feasibility studies. Backed by $28M in Series C funding, AtaCor aims to fast-track clinical and regulatory milestones while showcasing how Latin America accelerates Medtech innovation with world-class research infrastructure.
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CereVasc, Inc. has launched its first clinical trial in Argentina for the eShunt® System, a groundbreaking minimally invasive treatment for normal pressure hydrocephalus (NPH). Approved by ANMAT, the STRIDE trial will compare the new device with the traditional ventriculo-peritoneal (VP) shunt, marking the first innovation in NPH treatment in over 60 years. This trial reinforces Latin America’s emerging role in medical device research, with Argentina positioned as a key destination for first-in-human Medtech trials. Supported by leading regional CRO bioaccess®, the study aims to expand access to safer, less invasive NPH treatments for elderly patients.
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Clinical Trial in Paraguay Shows Positive Results
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A New Era in Surgery: Andromeda Surgical Performs the World’s First Robotic
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Axoft, Inc., a neurotechnology startup spun out of Harvard, has received ethics committee approval to begin its first human clinical trial in Panama for a revolutionary ultra-soft brain-computer interface (BCI). The trial, set for 2025 at The Panama Clinic, will test Axoft’s bioinspired neural implant designed to mimic the softness of brain tissue, aiming for unprecedented signal stability and biocompatibility.
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When we think of cutting-edge medical tech, the U.S. often takes center stage. But after a conversation with Julio Martinez-Clark, founder of bioaccess®, it's clear that Latin America is rapidly emerging as a global leader in medical device innovation.
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bioaccess®, a leading Latin American CRO, proudly announces that its co-founder and medical advisor, Dr. Pedro Martinez-Clark, has earned QM-IAOCR Internationally Qualified Clinical Research Investigator status. Awarded by the International Academy of Clinical Research (IAOCR), this prestigious accreditation recognizes Dr. Martinez-Clark's commitment to global clinical research excellence.
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Panama is solidifying its role as a strategic hub for medical device clinical trials, attracting innovators like Vivifi Medical for their first-in-human trials of the Calexis-Lap device, a pioneering solution for varicocele treatment. This marks another milestone in Latin America’s rapid rise as a destination for MedTech startups aiming to fast-track their products to market while maintaining rigorous clinical standards.
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Velocity Clinical Research, a global leader in fully integrated clinical site organizations, has announced its expansion into Latin America with the appointment of Renata Berardocco as Executive Vice President and Managing Director for the region. This move is part of Velocity’s broader growth strategy following a successful expansion in Europe. Latin America, which accounts for 10% of the world’s clinical research sites, is a critical focus for Velocity's expansion. The company's entry into this market is set to provide US MedTech companies with top-tier clinical research services in the region.
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Resurge Therapeutics, Inc., a leader in minimally invasive local drug delivery solutions for urology, has officially launched its first-in-human clinical study for a novel treatment of Benign Prostatic Hyperplasia (BPH) in the Dominican Republic. This significant milestone underscores the company's commitment to addressing unmet needs in urology and improving the quality of life for millions of men suffering from BPH.
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The study, approved by the Research Ethics Committee of the Paraguayan Institute of Social Studies, achieved all primary procedural success endpoints with zero adverse events. The trial, performed under the expert hands of Dr. Adrian Ebner, head of the cardiovascular department at Sanatorio Italiano, and Dr. Gagan Singh, an interventional cardiologist from UC Davis Health in Sacramento, was deemed a resounding success.
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Glucotrack, Inc. (Nasdaq: GCTK) has launched a feasibility study for its Continuous Blood Glucose Monitor (CBGM). This innovative device directly measures blood glucose levels, eliminating the lag seen with traditional monitors that use interstitial fluid. The CBGM offers a long-term, implantable solution that lasts up to three years without external components, making glucose monitoring more accurate and seamless.
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