Noticias

September 2, 2025

Hospital Internacional de Colombia and Synapse Global Theranostics Forge Landmark Theranostics Partnership

The Hospital Internacional de Colombia (HIC), in partnership with Synapse Global Theranostics, is launching Latin America’s first world-class Molecular Imaging and Theranostics Research Institute (MITRI). Powered by the IONETIX ION-12SC compact superconducting cyclotron, HIC will produce radiopharmaceuticals on site, enabling early-phase clinical trials and advancing precision medicine. This milestone positions Colombia as a regional leader in medical innovation, expanding patient access to cutting-edge therapies and reinforcing HIC’s standing as a globally accredited center of clinical research excellence.

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August 27, 2025

Newrotex Achieves World-First Implantation of SilkAxons™ Nerve Repair Technology, Pioneering a New Frontier for Large-Gap Peripheral Nerve Injuries

Newrotex Ltd. (Oxford, UK) has announced the world’s first human implantation of SilkAxons™, a silk-based bioengineered nerve guide designed to repair large peripheral nerve injuries up to 10 cm without the need for nerve grafts. The groundbreaking procedure, led by Dr. Ricardo Bermudez at The Panama Clinic, establishes crucial first-in-human safety and feasibility data. Managed by bioaccess, the trial highlights Panama’s streamlined clinical pathway and Newrotex’s global strategy to accelerate access to breakthrough solutions for patients suffering from severe nerve damage.

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July 29, 2025

Hidra Investigación Clínica Becomes First in Mexico to Pursue GCSA Global Quality Certification, Setting New Benchmark for Latin American Clinical Trials

Hidra Investigación Clínica is the first in Mexico to pursue GCSA certification, setting a new quality benchmark for clinical trials in Latin America to reduce risk and attract global sponsors.

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July 19, 2025

Nucleotron MIT and bioaccess® Launch Synapse Global Theranostics to Revolutionize Theranostics and Clinical Research Globally

Nucleotron MIT (a CIRA Health company) and bioaccess® have launched the joint venture Synapse Global Theranostics to solve Latin America's critical shortage of radiopharmaceuticals. Operating as a Management Services Organization (MSO), the new company will establish a network of advanced theranostics and clinical research centers by providing end-to-end services based on a proven U.S. model. The venture aims to improve patient access to precision medicine and enable high-value clinical trials, launching with an existing portfolio of projects in Latin America.

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July 9, 2025

Hospital Internacional de Colombia Achieves Historic Milestone: First in Latin America to Pursue Prestigious GCSA Certification

bioaccess®, the leading first-in-human contract research organization (CRO) in Latin America, proudly announces that our esteemed clinical research partner, Hospital Internacional de Colombia (HIC), has accepted a proposal to obtain the prestigious GCSA (Global Clinical Site Assessment) certification for their clinical research center. This landmark decision will make HIC the first research site in Latin America to achieve this globally recognized certification, reinforcing the region's growing prominence in international clinical research.

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July 7, 2025

Newrotex Receives Rapid Regulatory Approval in Panama for First-in-Human Trial of SilkAxons™ Nerve Regeneration Technology

Newrotex Limited has secured Panamanian regulatory clearance—just two weeks after submission—for its first-in-human trial of SilkAxons™, a spider-silk nerve guide engineered to bridge peripheral nerve gaps up to 10 cm. Conducted at The Panama Clinic with CRO partner bioaccess®, the study will generate critical safety and efficacy data and could redefine care for the 1.5 million patients worldwide who sustain severe nerve injuries each year.

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June 21, 2025

bioaccess® Announces Strategic Radiopharmaceutical Clinical Trial Services Partnership with Leading Miami-Based Molecular Diagnostics and Theranostics Center

bioaccess®, a leading contract research organization specializing in accelerated clinical trial pathways, today announced a strategic partnership with a premier Miami-based nuclear medicine and molecular imaging center to deliver specialized first-in-human clinical trial services for radiopharmaceutical companies.

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April 22, 2025

Axoft Completa con Éxito los Primeros Cuatro Casos de un Innovador Ensayo de Interfaz Cerebro-Ordenador en Panamá con el Apoyo de bioaccess®

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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April 22, 2025

IAOCR/GCSA lanza programas de certificación de investigación clínica acreditados en toda América Latina, anuncia el sitio web regional

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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March 24, 2025

México anuncia un acuerdo histórico para agilizar las aprobaciones de protocolos de investigación clínica para estudios autorizados en el extranjero

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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March 11, 2025

Care Access amplía su presencia en Latinoamérica con la adquisición estratégica de CEMEC de Brasil, lo que pone de relieve la creciente importancia de la región en la investigación clínica

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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March 1, 2025

AtaCor Medical lleva a cabo un innovador estudio de ICD extravascular en Paraguay, lo que refuerza la posición de Latinoamérica como principal destino de ensayos <i>first-in-human</i>

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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February 13, 2025

CereVasc Lanza un инновационный ensayo clínico en Argentina para un tratamiento innovador de la hidrocefalia normotensiva

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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February 1, 2025

Avances prometedores en la tecnología de punción transeptal: Ensayo clínico en Paraguay muestra resultados positivos

Clinical Trial in Paraguay Shows Positive Results

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January 9, 2025

Una Nueva Era en la Cirugía: Andromeda Surgical Realiza el Primer Procedimiento HoLEP Asistido por Robot del Mundo

A New Era in Surgery: Andromeda Surgical Performs the World’s First Robotic

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December 19, 2024

Axoft Iniciará un Estudio Clínico de Implante Cerebral, Marcando la Primera Vez que se Autoriza el Uso de Material de Inspiración Biológica en Humanos

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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December 16, 2024

The New World Podcast Entrevista a Julio G. Martinez-Clark, CEO de bioaccess®

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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December 14, 2024

El cofundador de bioaccess® logra una prestigiosa acreditación como investigador clínico

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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December 10, 2024

Vivifi Medical elige Panamá para el primer ensayo en humanos de un tratamiento revolucionario para el varicocele, lo que refuerza la posición de América Latina como principal destino para la innovación en tecnología médica

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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December 9, 2024

Velocity Clinical Research Acelera su Expansión Global con un Movimiento Estratégico hacia Latinoamérica

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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December 8, 2024

Resurge Therapeutics Inicia el Primer Estudio Clínico en Humanos para un Tratamiento Innovador de la HPB en la República Dominicana

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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December 4, 2024

Protaryx Medical Completa el Primer Ensayo Innovador en Humanos de un Dispositivo de Punción Transeptal en Latinoamérica

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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December 3, 2024

Avance en el Dolor Crónico: Nervonik Completa el Ensayo Clínico de la Tecnología de Estimulación Nerviosa en Panamá

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.

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November 30, 2024

IAOCR y bioaccess® se Asocian para Traer la Primera Acreditación de Investigación Clínica a Latinoamérica

On 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.

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November 22, 2024

Paraguay Lidera los Ensayos Exitosos del Dispositivo Whisper™ de Second Heart Assist Inc.

On 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.

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October 30, 2024

Advanced NanoTherapies Anuncia un Avance en el Tratamiento de Enfermedades Coronarias con SirPlux™ Duo

On 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.

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October 25, 2024

Samay Triunfa en MedTech 2024: Una Primicia Histórica para América Latina

Samay, 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.

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October 24, 2024

Tioga Cardiovascular Presenta el Novedoso Sistema Luna™ TMVR en los Primeros Ensayos en Humanos

On 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.

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October 13, 2024

PAVmed Logra un Hito Global en la Atención Médica con los Ensayos de PortIO™ en Colombia

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September 25, 2024

Arissa Medical Avanza con el Dispositivo Syntra en un Estudio de Tratamiento de Aneurismas Cerebrales

Arissa 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.

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September 19, 2024

Sparta Biomedical informa sobre el tratamiento de los primeros pacientes con el innovador dispositivo Ormi

Sparta 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.

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September 5, 2024

El gran avance de SonoVascular: Primer ensayo en humanos del sistema SonoThrombectomy™ en Chile

SonoVascular 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.

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August 16, 2024

Hito histórico para la investigación clínica en Latinoamérica: el equipo de bioaccess® logra la certificación ACRP

bioaccess®, 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.

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August 8, 2024

Sparta Biomedical, Inc. obtiene la aprobación en Colombia para un estudio clínico

Bogotá, 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.

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August 8, 2024

El robot de IA de Perceptive hace historia con el primer procedimiento dental totalmente automatizado

San 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.

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March 8, 2024

Cómo las empresas de tecnología médica están desbloqueando el potencial de América Latina en la investigación clínica

Los desafíos de las empresas emergentes de tecnología médica en el sector de dispositivos médicos en EE. UU. son multifacéticos y abarcan desde obstáculos regulatorios hasta recursos financieros limitados y plazos prolongados de reclutamiento de sujetos. Las empresas de tecnología médica de EE. UU. se enfrentan a problemas de profesionalismo, barreras idiomáticas, fragmentación de recursos y falta de estructuras corporativas de CRO en América Latina. Esto impide que los hospitales latinoamericanos tengan una comunicación y colaboración fluidas con los clientes estadounidenses de ensayos clínicos, en particular en el sector de los primeros ensayos clínicos en humanos de dispositivos médicos. Estos factores subrayan la urgente necesidad de un enfoque basado en soluciones para cerrar la brecha entre la innovación y la ejecución en América Latina.

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February 14, 2024

EyeFlow, Inc. Obtains Colombia Approval for its Pilot Clinical Study

El 14 de febrero de 2024, el INVIMA, la agencia reguladora de Colombia, aprobó un estudio piloto de eyeFlow, Inc. en un centro de investigación en Barranquilla. Este ensayo clínico piloto tiene como objetivo reclutar 60 sujetos en Colombia y durará aproximadamente 18 meses.

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January 17, 2024

i-Lumen Scientific, Inc. obtiene la aprobación en Colombia para su estudio clínico i-Sight 2

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.

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November 25, 2023

3ive Labs obtiene la aprobación en Colombia para su estudio BIPASS-AKI 2

El 15 de noviembre de 2023, el INVIMA, la agencia reguladora de Colombia, aprobó el estudio de viabilidad temprana BIPASS-AKI-2 de 3ive Labs, LLC (también conocida como “Roivios™), con su dispositivo de asistencia renal JuxtaFlow ® (RAD) en dos centros de investigación, uno en Barranquilla y el otro en Bucaramanga. Este estudio de viabilidad temprana tiene como objetivo reclutar hasta 40 sujetos en Colombia y durará aproximadamente 30 meses.

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September 28, 2023

Imperative Care obtiene la aprobación en Colombia para su estudio ADVANCE First-In-Human

El 28 de septiembre de 2023, el INVIMA, la agencia reguladora de Colombia, aprobó el estudio ADVANCE (primer estudio en humanos) de Imperative Care, Inc., que se llevará a cabo en un centro de investigación en Cartagena. El estudio ADVANCE tiene como objetivo reclutar hasta 15 sujetos de Colombia y tendrá una duración aproximada de cinco años.

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July 11, 2023

Revelando trayectorias inspiradoras: Explorando a los innovadores en la investigación médica y los ensayos clínicos

Embárquese en un viaje cautivador a medida que se desarrolla la excepcional historia de Pedro Martinez-Clark, desde su educación bicultural en Colombia hasta sus innovadoras experiencias de investigación en instituciones estimadas como la Universidad de Harvard y la Clínica Mayo. Descubra las fuerzas impulsoras detrás de su espíritu emprendedor, que condujo al establecimiento de nuestra empresa, Amavita Heart and Vascular Health™, una distinguida práctica cardiovascular comprometida con la prestación de atención centrada en el paciente y tratamientos pioneros.

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May 25, 2023

Cook Medical trata al primer paciente en el primer ensayo clínico en humanos para una válvula venosa

Cook Medical anuncia el primer paciente tratado en un estudio clínico para evaluar una nueva válvula venosa para el tratamiento de la insuficiencia venosa crónica. El paciente fue tratado por el Dr. Mauricio Alviar, cirujano vascular e investigador principal de la Clínica de la Costa en Barranquilla, Colombia.

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June 3, 2022

Spine Stabilization Technologies recurre a bioaccess™ para el lanzamiento de PerQdisc™ en América Latina

Spine Stabilization Technologies, LLC (SST), una empresa de Texas que desarrolla una tecnología de reemplazo del núcleo del disco vertebral diseñada para reemplazar el espacio físico del núcleo, ha decidido contratar a bioaccess™ como su CRO en Colombia para ampliar su red de centros de investigación clínica y aumentar los datos clínicos de su innovador y menos invasivo tratamiento: El sistema de reemplazo de núcleo PerQdisc™. bioaccess™ ayudará a SST a seleccionar al menos dos centros de investigación clínica y a obtener la aprobación del comité de ética (IRB) y la aprobación regulatoria de la agencia reguladora de Colombia (INVIMA).

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March 3, 2022

Greenlight Guru y bioaccess® se asocian para acelerar el acceso al mercado y mejorar los resultados de los pacientes en América Latina y más allá

Greenlight Guru y bioaccess® comparten el mismo objetivo y misión: mejorar la calidad de vida ayudando a los fabricantes de tecnología médica a llegar al mercado más rápido y con menos riesgo. Greenlight Guru y bioaccess® anuncian su acuerdo de cooperación para acercar a las empresas de dispositivos médicos a América Latina, realizar ensayos clínicos en fase temprana o vender sus innovaciones.

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September 3, 2021

Avantec Vascular Chooses bioaccess™ For A First-In-Human Clinical Study In Latin America

Avantec Vascular Corporation (https://www.avantecvascular.com/), una empresa del área de la Bahía de San Francisco dedicada al avance de las terapias vasculares a través de la innovación, ha elegido América Latina como destino para el primer estudio en humanos de un innovador dispositivo vascular. bioaccess™ ayudará a Avantec Vascular con la selección de un investigador principal, la presentación de su expediente regulatorio para las aprobaciones del ministerio de salud y otras actividades relacionadas con la realización del estudio.

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September 2, 2021

Welwaze y bioaccess™ colaboran para el lanzamiento de Celbrea® en Colombia

Welwaze Medical Inc., el fabricante del innovador dispositivo médico Celbrea® para la detección de signos tempranos de enfermedades mamarias, ha decidido ingresar al mercado latinoamericano y, a través de su distribuidor principal en América Latina, ha elegido a bioaccess™ como su firma consultora de asuntos regulatorios y acceso al mercado para ayudarle a ingresar al mercado colombiano.

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April 22, 2021

El Dr. Jorge Hernando Ulloa, investigador principal de Hancock Jaffe, presenta los datos del primer año de VenoValve en humanos en el Simposio Internacional Charing Cross

IRVINE, CA / 23 de abril de 2021 / Hancock Jaffe Laboratories, Inc. (NASDAQ:HJLI), un desarrollador de dispositivos médicos que restauran la salud cardíaca y vascular, anunció hoy que el Dr. Jorge Hernando Ulloa, el Investigador Principal del primer estudio en humanos de VenoValve® de HJLI en Bogotá, Colombia, presentó datos de un año esta semana pasada en el Simposio Internacional Charing Cross. El Simposio Internacional Charing Cross es el simposio mundial vascular y endovascular de mayor duración en Europa y cuenta con la asistencia de los principales expertos mundiales en medicina vascular y endovascular.

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October 14, 2020

ReGelTec trata con éxito a los primeros once pacientes con dolor lumbar crónico con HYDRAFIL™ en Colombia

ReGelTec, Inc., una empresa de dispositivos médicos que desarrolla un tratamiento percutáneo para el dolor lumbar crónico, anunció hoy que once pacientes con enfermedad degenerativa de disco han sido inscritos en el Estudio de Factibilidad Temprana de la Compañía en Barranquilla, Colombia. Los procedimientos fueron supervisados de forma remota a través de Zoom, y los once pacientes fueron tratados con éxito con HYDRAFIL™. Este hidrogel patentado se derrite antes de la inyección en el núcleo de un disco degenerado a través de una aguja de calibre 17.

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November 21, 2019

Un innovador ensayo clínico de terapia génica es el primero en el mundo que tiene como objetivo revertir 20 años de envejecimiento en humanos

MANHATTAN, Kan., 21 de noviembre de 2019 /PRNewswire/ -- Libella Gene Therapeutics, LLC ("Libella") anuncia un ensayo clínico de pago por juego aprobado por la junta de revisión institucional (IRB) en Colombia (América del Sur) utilizando terapia génica que tiene como objetivo tratar y, en última instancia, curar el envejecimiento. Esto podría llevar a Libella a ofrecer el único tratamiento del mundo para curar y revertir el envejecimiento en 20 años.

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July 22, 2019

Flow-FX elige Colombia para un primer ensayo clínico en humanos de su dispositivo médico Flow-Screw para la administración de antibióticos intraóseos (IO)

Flow-FX, una compañía de Mokena, IL, preparada para catalizar cambios drásticos en la cirugía ortopédica con el objetivo final de mejorar significativamente los resultados de los pacientes, ha seleccionado a Colombia y a bioaccess™ como su organización de investigación por contrato (CRO) para un primer estudio clínico en humanos sobre su innovador dispositivo médico Flow-Screw para la administración de antibióticos intraóseos (IO). El estudio se llevará a cabo en la Clínica La Misericordia en Barranquilla, Colombia, y será dirigido por el Dr. Carlos Severini, jefe de cirugía ortopédica y traumatología de la Clínica La Misericordia y de la Clínica Regional de la Policía Nacional, Mired IPS y profesor universitario de la Universidad Libre.

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March 22, 2019

GlobalCare Clinical Trials elige a bioaccess™ para expandir sus servicios ambulatorios a Colombia

GlobalCare Clinical Trials, LLC (“GCCT”) ha firmado un acuerdo con bioaccess.™ para expandir sus servicios ambulatorios de ensayos clínicos a Colombia. Bajo este acuerdo, GCCT aprovechará la amplia presencia de bioaccess.™ en Colombia para expandir su oferta de servicios ambulatorios en América Latina en apoyo de sus clientes farmacéuticos globales que necesitan que GCCT les ayude con las necesidades de sus pacientes de ensayos clínicos en el hogar en Colombia. La reducción del tiempo de reclutamiento de sujetos de ensayos clínicos en más del 50% y un aumento en la tasa de retención de sujetos de más del 95% se encuentran entre los resultados que han impulsado el rápido crecimiento de GCCT.

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February 17, 2019

IDX elige a bioaccess™ para buscar socios de colaboración de datos de licencias en América Latina

IDx Technologies Inc. ha elegido a bioaccess.™ como su consultor de acceso al mercado para buscar, encontrar y seleccionar centros de oftalmología de alto volumen en América Latina que puedan ser sus socios de colaboración de licencias de datos para su innovador sistema autónomo de inteligencia artificial (IA) que detecta enfermedades en imágenes médicas. Al permitir la evaluación diagnóstica en entornos de atención primaria, IDx tiene como objetivo aumentar el acceso de los pacientes a la detección de enfermedades asequible y de alta calidad.

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October 31, 2018

Hernán Orjuela —Un destacado presentador de televisión colombiano— entrevista a Julio G. Martinez-Cark, CEO de Bioaccess™

Hernán 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 Comienza el Estudio Clínico de un Monitor Revolucionario de Glucosa en Sangre en Brasil

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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