Noticias

April 22, 2025

Axoft concluye con éxito los cuatro primeros casos del 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 acreditada en toda América Latina y anuncia un 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 la aprobación 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 América Latina con la adquisición estratégica de la brasileña CEMEC, destacando 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 DAI extravascular en Paraguay, reforzando la posición de Latinoamérica como primer destino de ensayos en humanos

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 ensayo clínico pionero en Argentina para un tratamiento innovador de la NPH

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

Prometedores avances en la tecnología de punción transeptal: Un ensayo clínico en Paraguay arroja resultados positivos

Clinical Trial in Paraguay Shows Positive Results

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January 9, 2025

Una nueva era en cirugía: Andromeda Surgical realiza la primera intervención HoLEP asistida 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 sobre implantes cerebrales, la primera vez que se autoriza el uso en seres humanos de un material inspirado en la biología.

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, director general 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® obtiene la prestigiosa acreditación de investigador de investigación clínica

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 selecciona a Panamá para el primer ensayo en humanos de un revolucionario tratamiento para el varicocele, reforzando a 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 lanza el primer estudio clínico en humanos para un tratamiento innovador de la HBP 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 finaliza el primer ensayo en humanos del 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

Gran avance en el dolor crónico: Nervonik completa el ensayo clínico de su 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

La IAOCR y bioaccess® se asocian para llevar la primera acreditación de investigación clínica a América Latina

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 con éxito los ensayos 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 gran 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 innovador sistema Luna™ TMVR en sus 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 sanitario mundial con los ensayos de PortIO™ en Colombia

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September 25, 2024

Arissa Medical avanza con el dispositivo Syntra en un estudio sobre el 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 del 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

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 América Latina: 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 de 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 la primera intervención dental totalmente automatizada

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 liberando el potencial de América Latina en investigación clínica

Los retos a los que se enfrentan las nuevas empresas de tecnología médica en el sector de los dispositivos médicos en EE.UU. son múltiples y van desde los obstáculos normativos hasta los recursos financieros limitados y los prolongados plazos de reclutamiento de sujetos. Las empresas estadounidenses de tecnología médica se enfrentan al profesionalismo, las barreras idiomáticas, la fragmentación de los recursos y la 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, particularmente en la industria de ensayos clínicos de dispositivos médicos por primera vez en humanos. Estos factores subrayan la urgente necesidad de un enfoque orientado a soluciones para salvar 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, INVIMA, la agencia reguladora de Colombia, aprobó un estudio piloto de eyeFlow, Inc. en un centro de investigación en Barranquilla. Este ensayo clínico piloto pretende reclutar a 60 sujetos en Colombia y durará aproximadamente 18 meses.

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January 17, 2024

i-Lumen Scientific, Inc. Obtiene la aprobación de 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 de Colombia para su estudio BIPASS-AKI 2

El 15 de noviembre de 2023, INVIMA, la agencia reguladora de Colombia, aprobó el estudio de factibilidad temprana BIPASS-AKI-2 de 3ive Labs, LLC (alias "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 pretende reclutar hasta 40 sujetos en Colombia y tendrá una duración aproximada de 30 meses.

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September 28, 2023

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

El 28 de septiembre de 2023, INVIMA, la agencia reguladora de Colombia, aprobó el primer estudio en humanos ADVANCE 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 durará aproximadamente cinco años.

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July 11, 2023

Unveiling Inspirational Journeys: Explorando a los innovadores de la investigación médica y los ensayos clínicos

Embárquese en un viaje cautivador a través de la excepcional historia de Pedro Martínez-Clark, desde su educación bicultural en Colombia hasta sus innovadoras experiencias de investigación en prestigiosas instituciones como la Universidad de Harvard y la Clínica Mayo. Descubra las fuerzas motrices de su espíritu emprendedor, que le llevaron a crear nuestra empresa, Amavita Heart and Vascular Health™, una distinguida práctica cardiovascular comprometida con la prestación de una 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 de 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 Latinoamérica.

Spine Stabilization Technologies, LLC (SST), una empresa de Texas que desarrolla una tecnología de sustitución 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 tratamiento innovador y menos invasivo: El Sistema de Reemplazo de Núcleo PerQdisc™. bioaccess™ ayudará a SST a seleccionar al menos dos sitios de investigación clínica y a obtener la aprobación de la junta de revisión institucional (IRB)/comité de ética y la aprobación regulatoria en 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 Medtech a llegar al mercado más rápido y con menos riesgos. Greenlight Guru y bioaccess® anuncian su acuerdo de cooperación para acercar a las empresas de dispositivos médicos a América Latina, realizar ensayos clínicos en etapas tempranas 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 Latinoamérica 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 dossier regulatorio para las aprobaciones del ministerio de sanidad 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 enfermedad mamaria, ha decidido entrar en el mercado latinoamericano y a través de su distribuidor maestro en América Latina, ha elegido a bioaccess™ como su empresa de consultoría regulatoria y de acceso al mercado para ayudarle a entrar en el mercado colombiano.

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April 22, 2021

El Dr. Jorge Hernando Ulloa, investigador principal de Hancock Jaffe, presenta los primeros datos en humanos de VenoValve en un simposio internacional de Charing Cross

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

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October 14, 2020

ReGelTec trata con éxito a los once primeros pacientes con lumbalgia crónica con HYDRAFIL™ en Colombia

ReGelTec, Inc. una compañía de dispositivos médicos que desarrolla un tratamiento percutáneo para el dolor lumbar crónico, anunció hoy que once pacientes con enfermedad degenerativa del disco se han inscrito en el Estudio de Viabilidad Temprana de la Compañía en Barranquilla, Colombia. Los procedimientos se realizaron a distancia mediante Zoom, y los once pacientes fueron tratados con éxito con HYDRAFIL™. Este hidrogel patentado se funde antes de inyectarlo en el núcleo de un disco degenerado mediante una aguja de calibre 17.

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November 21, 2019

Un ensayo clínico de terapia génica es el primero del mundo que pretende 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 aprobado por la junta de revisión institucional (IRB, por sus siglas en inglés) en Colombia (Sudamérica) con terapia génica que pretende 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 selecciona Colombia para el primer ensayo clínico en humanos de su dispositivo médico Flow-Screw para la administración intraósea (io) de antibióticos

Flow-FX, una empresa 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 estudio clínico por primera vez 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 de Barranquilla (Colombia) y estará dirigido por el doctor 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 bioaccess™ para ampliar sus servicios ambulatorios a Colombia

GlobalCare Clinical Trials, LLC ("GCCT") ha firmado un acuerdo con bioaccess.™ para ampliar sus servicios ambulatorios de ensayos clínicos a Colombia. En virtud de este acuerdo, GCCT aprovechará la amplia presencia de bioaccess.™ en Colombia para ampliar su oferta de servicios ambulatorios en América Latina en apoyo de sus clientes farmacéuticos globales que necesitan GCCT para ayudarles con sus necesidades de 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 el aumento de la tasa de retención de sujetos en más del 95% son algunos de los resultados que han impulsado el rápido crecimiento de GCCT.

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February 17, 2019

IDX elige bioaccess™ para buscar socios colaboradores 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 licencia 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 de alta calidad y asequible.

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October 31, 2018

Hernán Orjuela, destacado presentador de televisión colombiano, entrevista a Julio G. Martinez-Cark, director general 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 inicia en Brasil el estudio clínico de un revolucionario medidor de glucosa en sangre

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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