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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On December 2, 2024, medical device company Nervonik completed its first-in-human clinical trial in Panama City, testing its innovative peripheral nerve stimulation (PNS) technology for chronic pain relief. Developed by Dr. Aydin Babakhani at UCLA, the wearable device delivers personalized stimulation to patients with chronic shoulder and knee pain. The trial, conducted at Punta Pacifica Hospital, confirmed the safety and effectiveness of the technology. Experts involved praised the therapy's success and its potential to revolutionize chronic pain treatment. Full study results will be released in early 2025. Nervonik aims to provide safer alternatives to opioids and spinal-cord stimulators.
Read MoreOn November 30, 2024, the International Accrediting Organization for Clinical Research (IAOCR) and Latin America-focused CRO bioaccess® announced a strategic partnership to launch the region’s first certification and accreditation program for clinical research professionals and sites. This initiative introduces the Global Quality Standard for Clinical Research Sites (GCSA), aiming to elevate industry quality, align with international standards, and boost Latin America’s competitiveness in global clinical trials. The program provides standardized training, international recognition, and support for attracting more research to the region, ultimately improving healthcare outcomes.
Read MoreOn November 19, 2024, Utah-based Second Heart Assist Inc. announced the successful completion of a second round of case studies for its Whisper™ percutaneous mechanical circulatory support device. Conducted in Asunción, Paraguay, by Dr. Adrian Ebner and his team, the study evaluated the device's safety and effectiveness in six patients with acute decompensated heart failure (ADHF). The Whisper™ device offers a significant advancement in cardiac care by providing high blood flow at low RPMs, reducing the risk of hemolysis and preserving kidney function. Experts highlighted its quick deployment and performance advantages over traditional devices. Used during high-risk cardiac procedures and emergencies, Whisper™ helps stabilize patients and prevent organ failure. The successful trials mark a step toward expanding clinical studies into the U.S., reinforcing Second Heart Assist’s mission to transform cardiovascular treatment.
Read MoreOn October 26, 2024, Advanced NanoTherapies (ANT) announced promising results from initial human trials of its SirPlux™ Duo Drug-Coated Balloon (DCB), a novel treatment for coronary de novo disease. The DCB combines sirolimus and paclitaxel to prevent restenosis and maintain vascular patency, with trials conducted at Cecanot Hospital in the Dominican Republic. ANT plans to launch the DYNAMIC DUO I study in the U.S. to further evaluate the device's safety and efficacy. This early feasibility trial will include patients with various forms of angina and NSTEMI. The SirPlux™ Duo DCB uses advanced nanoparticle technology to deliver drugs directly to coronary tissue without permanent implants, offering a less invasive alternative to traditional treatments. These developments could pave the way for broader U.S. and international commercialization of the device.
Read MoreSamay, a Latin American medtech startup, made history by winning the 2024 Early-Stage Grand Prize at The MedTech Conference—the first Latin American company to do so. The award includes a $350,000 non-dilutive prize and recognizes their innovative Sylvee device, designed to improve the diagnosis and monitoring of COPD, a major global health concern. Sylvee provides detailed respiratory data to help manage daily lung health and address widespread misdiagnoses. Samay stood out among strong finalists like BrainSpace and NeuroBionics, showcasing the growing impact of Latin American innovation in global healthcare. MedTech World’s CEO praised the win as a milestone for both Samay and the region. The next major industry event, MedTech Malta 2024, will take place November 6–8 in Valletta, bringing together leaders and innovators from around the world.
Read MoreOn October 23, 2024, Tioga Cardiovascular, part of the Shifamed portfolio, announced the successful first human use of its Luna™ transcatheter mitral valve replacement (TMVR) system. The initial procedures using the 28 Fr. Luna™ device took place in Paraguay and Georgia, with excellent post-operative results. Led by Dr. Adrian Ebner and Dr. Irakli Gogorishvili—alongside U.S. experts such as Dr. Azeem Latib—the trials mark a major advancement in minimally invasive mitral valve treatment. The system is engineered to address the complex challenges of mitral valve replacement. Tioga CEO Mike Dineen highlighted the collaborative effort and announced that more details will be shared during a special session at the Transcatheter Cardiovascular Therapeutics (TCT) Conference on October 29 in Washington, DC.
Read MoreArissa Medical, Inc., a California-based medical device company, has successfully enrolled its third patient group in the Syntra pilot study, which evaluates the safety and effectiveness of its intrasaccular scaffold device for treating wide-neck intracranial aneurysms, including irregular and bifurcation types. The latest procedures were conducted in Santiago, Chile, at the Instituto de Neurocirugía Dr. Alfonso Asenjo, led by Dr. Juan Gabriel Sordo. Early contributors Dr. Gary Duckwiler (UCLA) and Dr. Luis Augusto Lemme (Argentina) praised the device for its smooth delivery and effectiveness in treating complex aneurysms. The Syntra device offers a novel intrasaccular structure that reduces aneurysm neck diameter and facilitates coiling, without requiring dual antiplatelet therapy, thanks to its fully intrasaccular design. This progress marks a promising step in developing safer and more effective aneurysm treatment options.
Read MoreSparta Biomedical Begins First-in-Human Trial of Ormi™ Cartilage Repair Device Morrisville, NC – September 13, 2024 – Sparta Biomedical has successfully implanted its Ormi™ device in patients with focal knee lesions as part of a first-in-human clinical trial in Colombia and the Dominican Republic. The study evaluates the safety and early outcomes of Ormi, which is designed to treat knee pain caused by damaged articular cartilage in the femoral condyle. The Ormi device is built on Sparta’s Galene platform, a synthetic cartilage engineered to mimic native hyaline cartilage. It combines Galene with a titanium stemmed base for secure fixation. Unlike traditional treatments, Ormi does not rely on biological regeneration and offers immediate structural support, enabling weight-bearing and full range of motion shortly after implantation. Clinical investigators have praised Ormi for its ease of implantation, strong fixation, and positive early recovery results. The device is being tested at Clinica de la Mujer in Bogotá and HOMS in Santiago. Sparta Biomedical's CEO, Dushyanth Surakanti, emphasized Ormi’s potential to revolutionize knee osteoarthritis treatment, noting the lack of effective solutions for millions suffering from focal cartilage lesions. Ormi has also received the U.S. FDA Breakthrough Device Designation. With 651 million people globally affected by knee osteoarthritis, Ormi offers a non-biologic, durable alternative to current therapies that may be slower or less reliable.
Read MoreSonoVascular Treats First Patient with New Clot-Removing Device in Chile Chapel Hill, NC – SonoVascular, Inc. has successfully treated its first patient using the SonoThrombectomy™ system at DIPRECA Hospital in Santiago, Chile, marking a major milestone in the treatment of venous thromboembolism (VTE). The system, led by Dr. Manuel Espíndola and Dr. Albrecht Krämer, combines ultrasound microbubble cavitation with low-dose clot-dissolving medication, offering a minimally invasive and safe alternative to traditional VTE procedures. The treatment achieved rapid clot removal while protecting the vascular walls, with the patient discharged just 48 hours later and no complications reported. This outcome supports the system’s potential to improve VTE outcomes while avoiding the blood loss and risks seen with more aggressive techniques.
Read Morebioaccess®, a Colombian-based clinical research organization, has announced that several key members of its team have earned the prestigious ACRP (Association of Clinical Research Professionals) certification. This achievement reinforces the company's commitment to high standards in clinical research and positions it as a leader in Latin America’s medical research sector. Certified team members include: Sergio Alvarado – Clinical Trial Manager with extensive trial oversight experience. Juan Cuya – Clinical Trial Associate and regulatory expert with a background in consulting for health organizations. Nevianni Velez – Clinical Trial Manager recognized for managing multi-center trials. Jhonatan Espinosa – Clinical Trial Manager skilled in project execution and stakeholder coordination. CEO Julio Martinez-Clark highlighted this milestone as a testament to the team's dedication and a step forward in supporting MedTech innovation in the region. The ACRP certification is known globally as a benchmark for clinical research professionalism and excellence. About bioaccess®: Specializes in high-quality clinical trials for MedTech startups in Latin America. About ACRP: A global non-profit promoting excellence in clinical research since 1976.
Read MoreBogotá, June 12, 2024 — Sparta Biomedical, Inc. has received regulatory approval from INVIMA to begin its first-in-human clinical study in Colombia. The study will take place at a single site in Bogotá, enroll 15 participants, and span approximately 2 years. Sparta’s focus is on orthopedic innovation, particularly with its breakthrough material Galene, a proprietary bionic cartilage designed to mimic natural cartilage. The technology aims to reduce pain and preserve joint mobility in patients with osteoarthritis, a condition that severely limits movement and causes chronic pain. Unlike traditional treatments, Galene offers potential advantages in durability, simplicity of implantation, and recovery time, aiming to improve outcomes and quality of life for patients.
Read MoreSan Francisco, August 2024 — Perceptive, a Boston-based dental technology company, has made history by completing the first-ever fully automated dental procedure on a human, reducing the time for a dental crown placement from over two hours to just 15 minutes. Powered by AI, 3D imaging, and robotics, Perceptive's system performs dental treatments with unmatched speed and precision. The technology uses optical coherence tomography (OCT) to diagnose beneath the gum line and plan treatments accurately—without radiation.
Read MoreMedtech 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.
Read MoreOn 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.
Read MoreOn 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.
Read MoreOn 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.
Read MoreOn 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.
Read MoreEmbark on a captivating journey as Pedro Martinez-Clark's exceptional story unfolds, from his bicultural upbringing in Colombia to his groundbreaking research experiences at esteemed institutions like Harvard University and Mayo Clinic. Discover the driving forces behind his entrepreneurial spirit, which led to the establishment of our company, Amavita Heart and Vascular Health™ - a distinguished cardiovascular practice committed to delivering patient-centric care and pioneering treatments.
Read MoreCook 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.
Read MoreSpine Stabilization Technologies, LLC (SST), a Texas company developing a spine disc nucleus replacement technology designed to replace the physical space of the nucleus, has decided to engage bioaccess™ as its CRO in Colombia to expand its clinical research network of sites and augment the clinical data of its innovative and less invasive treatment: The PerQdisc™ Nucleus Replacement System.. bioaccess™ will help SST select at least two clinical research sites and obtain institutional review board (IRB)/ethics committee and regulatory approval at Colombia's regulatory agency (INVIMA).
Read MoreGreenlight Guru and bioaccess® share the same goal and mission: to enhance the quality of life by helping Medtech manufacturers get to market faster and with less risk. Greenlight Guru and bioaccess® announce their cooperation agreement to bring medical device companies closer to Latin America, conduct early-stage clinical trials, or sell their innovations.
Read MoreAvantec Vascular Corporation (https://www.avantecvascular.com/), a company in the San Francisco Bay Area dedicated to advancing vascular therapies through innovation, has chosen Latin America as the destination for the first-in-human study of an innovative vascular device. bioaccess™ will help Avantec Vascular with the selection of a principal investigator, the submission of its regulatory dossier for the ministry of health approvals, and other activities related to carrying out the study.
Read MoreWelwaze Medical Inc., the manufacturer of the innovative Celbrea® medical device for the detection of early signs of breast disease, has decided to enter the Latin American market and through its master distributor in Latin America, has chosen bioaccess™ as its regulatory and market access consulting firm to aid it in entering the Colombian market.
Read MoreIRVINE, CA / April 23, 2021 / Hancock Jaffe Laboratories, Inc. (NASDAQ:HJLI), a developer of medical devices that restore cardiac and vascular health, today announced that Dr. Jorge Hernando Ulloa, the Principal Investigator for HJLI’s first-in-human VenoValve® study in Bogota, Colombia, presented one year data this past week at the Charing Cross International Symposium. The Charing Cross International Symposium is the longest-running vascular and endovascular global symposium in Europe and is attended by the world’s leading experts in vascular and endovascular medicine.
Read MoreReGelTec, Inc., a medical device company developing a percutaneous treatment for chronic low back pain, announced today that eleven patients with degenerative disc disease have been enrolled in the Company’s Early Feasibility Study in Barranquilla, Colombia. The procedures were proctored remotely via Zoom, and all eleven patients were successfully treated with HYDRAFIL™. This patented hydrogel is melted before injection into the nucleus of a degenerated disc via a 17-gauge needle.
Read MoreMANHATTAN, Kan., Nov. 21, 2019 /PRNewswire/ -- Libella Gene Therapeutics, LLC ("Libella") announces an institutional review board (IRB)-approved pay-to-play clinical trial in Colombia (South America) using gene therapy that aims to treat and ultimately cure aging. This could lead to Libella offering the world's only treatment to cure and reverse aging by 20 years.
Read MoreFlow-FX, a Mokena, IL company poised to catalyze dramatic changes in orthopedic surgery with the ultimate goal of significantly improving patient outcomes, has selected Colombia and bioaccess™ as its contract research organization (CRO) for a first-in-human clinical study on its innovative Flow-Screw medical device for the delivery of intraosseous (IO) antibiotics. The study will be conducted at Clinical La Misericordia in Barranquilla, Colombia and will be led by Dr. Carlos Severini —chief of orthopedic surgery and trauma at Clinica La Misericordia and at Clinica Regional de la Policía Nacional, Mired IPS and university professor at Universidad Libre.
Read MoreGlobalCare Clinical Trials, LLC (“GCCT") has executed an agreement with bioaccess.™ to expand its clinical trial ambulatory services to Colombia. Under this agreement, GCCT will leverage bioaccess.™ extensive presence in Colombia to expand its ambulatory service offering in Latin America in support of its global pharmaceutical clients that need GCCT to assist them with their clinical trial patient in-home needs in Colombia. Reduction in clinical trial subject recruitment time by over 50% and an increase in subject retention rate of over 95% are among the results that have spurred GCCT's rapid growth.
Read MoreIDx Technologies Inc. has chosen bioaccess.™ as its market access consultant to search, find, and select high-volume ophthalmology centers in Latin America that can be its data-licensing collaboration partners for its breakthrough autonomous artificial intelligence (AI) system that detects diseases in medical images. By enabling diagnostic assessment in primary care settings, IDx aims to increase patient access to high-quality, affordable disease detection.
Read MoreHernán Orjuela interviews Julio G. Martinez-Clark, CEO of bioaccess.™, on his show Entrevistas con Hernán. bioaccess.™ is a contract research organization (CRO) based in Orlando, FL, that helps medical technology companies develop and commercialize their innovations in Colombia.
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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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