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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