New Members

07/03/2024, Lucerne University of Applied Sciences and Arts, Luzern, Switzerland

07/03/2024, Hassan first University , Settat, Morocco

07/03/2024, Hochschule Luzern T&A, Horw, Switzerland

07/03/2024, Università Politecnica delle Marche, Ancona AN, Italy

01/29/2024, National Taiwan University of Science and Technology, Taipei City, Taiwan

10/17/2023, University of Toronto , Mississauga Ontario , Canada

7/27/2023, University Toledo, Toledo, USA

4/5/2023, ZheJiang Normal University, Zhejiang Province, China

04/11/2023, University of Nebraska at Omaha, Omaha, USA

01/17/2023, University of Limerick, Limerick, Ireland

09/13/2023, Universidad del Rosario, Bogonta , Colombia

08/22/2023, BioCardia, Sunny Val, USA Bringing personalized medicine to cell therapy for heart disease

06/27/2022, Punjabi University Patiala, Punjab, India

06/01/2022, Kestra Medical Technologies, Inc., Kirkland, USA Kestra Medical Technologies is a wearable medical device and digital healthcare company that protects patients with diagnostic and therapeutic technologies that are intuitive, intelligent, and mobile.

06/07/2021, University of Valladolid, Valladolid, Spain

04/30/2021, ETH Zurich, Zürich, Switzerland

04/30/2021, University Carlos III Madrid Lopez, Madrid, Spain

04/30/2021, Shahid Rajaee Teacher Training University, Tehran Province, Iran

01/12/2021, The National Academy of Sciences of Ukraine, Kyiv, Ukraine

01/12/2021, Universidad Rey Juan Carlos, Madrid, Spain

01/12/2021, Universidad iberoamericana, Mexico City, MEXICO

01/12/2021, Clinical Technology , Brecksville, USA

06/05/2020, Universitat Pompeu Fabra, Barcelona, Spain

06/05/2020, SUNY Upstate Medical University, Syracuse, USA

05/28/2020, University of Kent, Canterbury, United Kingdom

05/28/2020, The University of AIZU, Fukushima, Japan

05/28/2020, National Taiwan University, Taipei City, Taiwan

02/28/2020, Indian Institute of Space & Science & Tech, Kerala, India To be a world class educational and research institution contributing significantly to the Space endeavours

02/20/2020, Monash University, Melbourne, Australia Monash University is one of Australia’s leading universities and ranks among the world’s top 100. We help change lives through research and education.

12/24/2019, Universidad Politécnica de Madrid, Madrid, SPAIN

11/11/2019, University of Verona, Verona, ITALY

11/11/2019, University of Pittsburgh, Pittsburgh, USA The University of Pittsburgh is a state-related research university, founded as the Pittsburgh Academy in 1787. Pitt is a member of the Association of American Universities (AAU), which comprises 62 preeminent doctorate-granting research institutions in North America.

11/11/2019, Tianjin University of Technology, Tianjin , CHINA Tianjin University is the oldest institution of higher education in the modern history of China. Founded in 1895 as Peiyang University, Tianjin University’s 123-year history is the epitome of the progress of modern Chinese higher education, embodying the Chinese people’s indomitability through challenging times.

11/01/2019, Parsons Government Service, HOUSTON, USA Founded in 1944, Parsons Corporation --- a digitally enabled solutions provider --- is focused on the defense, intelligence, and critical infrastructure markets.

10/31/2019, University of Liverpool, Liverpool, UK

10/31/2019, Air University Islamabad, Islamabad, Pakistan The mission of Air University is to achieve excellence in teaching and research for producing graduates with sound professional knowledge, integrity of character, a keen sense of social responsibility and a passion for lifelong learning. The University shall stand committed to creating an environment conducive for attracting the best students, faculty and supporting staff for contributing to the development of a prosperous, peaceful and enlightened society.

05/15/2019, University of Wisconsin, Madison, USA For 168 years, this campus has been a catalyst for the extraordinary. As a public land-grant university and prolific research institution, our students, staff, and faculty members partake in a world-class education and solve real-world problems

05/15/2019, Utrecht University, Utrecht, NETHERLANDS

05/15/2019, University of Michigan, Ann Arbor, USA

05/15/2019, University of California Los Angeles, os Angeles, USA

05/15/2019, University of California Irvine, Irvine, USA Founded in 1965, UCI is the youngest member of the prestigious Association of American Universities. The campus has produced three Nobel laureates and is known for its academic achievement, premier research, innovation and anteater mascot. Led by Chancellor Howard Gillman, UCI has more than 36,000 students and offers 222 degree programs.

05/15/2019, Technion , Haifa, ISRAEL A science and technology research university, among the world’s top ten,

05/15/2019, Tampere University of Technology, Tampere, FINLAND Tampere University is one of the most multidisciplinary universities in Finland. Almost all internationally recognised fields of study are represented at our university.

05/15/2019, Shenzhen Institute of Advanced Technology, Shenzhen, CHINA

05/15/2019, Shanghai Jiao Tong University, Shanghai, CHINA

05/15/2019, Saint Petersburg Electrotechnical University, Sankt-Peterburg, RUSSIA Saint Petersburg Electrotechnical University "LETI" is one of the world's largest education centers specializing in radio engineering, electrical engineering, electronics and computer science.

05/15/2019, Pontifical Xavierian University, Bogotá, Colombia

05/15/2019, University of Sfax , Sfax, TUNISIA

05/15/2019, King Saud University, Riyadh , SAUDIA ARABIA

05/15/2019, Khalifa University, Abu Dhabi, UNITED ARAB EMIRATES The newly-established Khalifa University of Science and Technology (KU) combines the Masdar Institute of Science and Technology (MI), the Khalifa University of Science, Technology and Research (KUSTAR) and the Petroleum Institute (PI) into one world-class, research-intensive institution, seamlessly integrating research and education to produce world leaders and critical thinkers in applied science and engineering.

05/15/2019, Argentine Institute of Mathematics, Buenos Aires , ARGENTINA

05/15/2019, INESC TEC, Porto, PORTUGAL INESC TEC is a private non-profit research institution, dedicated to scientific research and technological development, technology transfer, advanced consulting and training, and pre-incubation of new technology-based companies.

05/15/2019, Fraunhofer HHI, Berlin, GERMANY Innovations for the digital society of the future are the focus of research and development work at the Fraunhofer Heinrich Hertz Institute HHI. In this area, Fraunhofer HHI is a world leader in the development of mobile and optical communication networks and systems, fiber optical sensor systems as well as the processing and coding of video signals.

05/15/2019, Heart Input Output, Inc., Pittsburgh, USA

05/15/2019, Harrisburg University, Harrisburg, USA

05/15/2019, Warsaw University of Technology, Warsaw, POLAND

05/15/2019, Carlos III University of Madrid , Madrid, SPAIN UC3M´s mission is to contribute to the improvement of society through teaching of the highest quality and cutting-edge research in line with stringent international guidelines. The University aspires to excellence in all its activities, with the aim of becoming one of the top universities in Europe.

05/15/2019, Beth Israel Deaconess Medical Center, Boston, USA BIDMC is part of Beth Israel Lahey Health, a new health care system that brings together academic medical centers and teaching hospitals, community and specialty hospitals, more than 4,000 physicians and 35,000 employees in a shared mission to expand access to great care and advance the science and practice of medicine through groundbreaking research and education.

[01/24/2018], Biological Research Center of the Hungarian Academy of Sciences, Szeged, Hungary The BRC is an outstanding institution of the internationally acknowledged Hungarian biological research. The Biological Research Centre was founded in 1971. The 4 institutes of BRC - the Institutes of Biophysics, Biochemistry, Genetics and Plant Biology - employ about 260 scientists whose work is hall-marked by highly appreciated international scientific publications and patents. The research topics include several fields of molecular and cell biology from the industrial utilization of bacteria through controlled improvement of cultivated plants to the problems of human health and environmental protection. BRC is mainly a scientific basic research centre, but scientists of BRC play an initiative role in the foundation and promotion of biotechnological companies, as well as in educational duties.

[01/02/2018], Universidade Federal do Maranhão, São Luís - MA, Brazil Founded in 1966, Universidade Federal do Maranhão (Federal University of Maranhão) is a non-profit public higher education institution located in the medium-sized city of São Luis (population range of 500,000-1,000,000 inhabitants), Maranhao. Officially accredited and/or recognized by the Ministério da Educação, Brazil (Ministry of Education, Brazil), Universidade Federal do Maranhão (UFMA) is a coeducational higher education institution. Universidade Federal do Maranhão (UFMA) offers courses and programs leading to officially recognized higher education degrees such as bachelor degrees in several areas of study.

[03/12/2018], University of Vigo, Viigo, Spain The University of Vigo is a modern and innovative institution, which offers more than 50 degree courses on three different campuses: a) the Vigo campus – which includes both the Lagoas Marcosende campus (15 km from the city centre) and the historical campus at Torrecedeira, b) the Ourense campus, and c) the Pontevedra campus. More than 24,000 students are registered at the three campuses, and 1,600 lecturers teach undergraduate and postgraduate programs at the University of Vigo. Our institution offers degrees in all knowledge areas, especially in the scientific-technological field. Some of the degrees are unique within the Galician university system and not very common in the rest of the Spanish universities: Fine Arts on the Pontevedra Campus, Mining and Telecommunication Engineering on the Vigo campus, and Tourism on the Ourense campus.

[01/24/2018], Stanford Medicine, Stanford, USA A leader in the biomedical revolution, Stanford Medicine has a long tradition of leadership in pioneering research, creative teaching protocols and effective clinical therapies. Our close proximity to the resources of the university — including the Schools of Business, Law, Humanities and Sciences, and Engineering, our seamless relationship with our affiliated adult and children’s hospitals, and our ongoing associations with the entrepreneurial endeavors of Silicon Valley, make us uniquely positioned to accelerate the pace at which new knowledge is translated into tangible health benefits.

[01/24/2018], The Austrian Research Institute for Artificial Intelligence, Vienna, Austria The Austrian Research Institute for Artificial Intelligence (OFAI) is one of Europe's leading non-profit contract research institutions. Services offered range from consultancy, basic and applied research on a contractual base, to working as partner or prime contractor in scientific projects on a national or European level, with a twenty year experience in a diversity of domains, from economic, engineering, administrative to social and cultural tasks.

[10/25/2017], University of Tennessee Health Science Center, Memphis, USA As the flagship statewide, public, academic health system, the mission of the University of Tennessee Health Science Center is to bring the benefits of the health sciences to the achievement and maintenance of human health, with a focus on the citizens of Tennessee and the region, by pursuing an integrated program of education, research, clinical care and public service. Employing more than 6,000 people on its faculty, staff and not-for-profit corporation faculty practice groups, UTHSC contributes more than $2.7 billion to the economy of Tennessee.

[10/24/2017], Dankook University, Yongin-si,, South Korea Dankook University cherishes truth and service as its guiding principles. It is our belief that the purpose of research and study lies beyond simply acquiring tools for sustenance – the ultimate purpose of higher learning is the enrichment of human knowledge and culture. Principally, scholars are obligated to return such knowledge to society and contribute to historical advancement. They must seek to develop sharp, critical minds and a righteous moral character; by doing so and voluntarily participating in the betterment of society as a whole, one embodies the path Dankook wishes to set forth. It has been the unwavering devotion towards realizing such duties of higher education and patriotism that has led to Dankook University’s existence in its current form

[09/28/2017], Chinese PLA General Hospital, Beijing, China The Chinese People’s Liberation Army (PLA) General Hospital is a large, modern, comprehensive teaching hospital providing high quality health care and opportunities for postgraduate medical education and scientific research. The hospital was founded in 1953, and is situated on the western part of the 4th Beijing Ring Road. The hospital has 165 clinical medical departments, which each year accept 49,000 outpatients and emergency patients while performing nearly 90,000 surgery cases. The medical- health care center is noted for providing high-end preventive care services.

[07/20/2017], University of Central Florida, Orlando, USA The Advanced Research Computing Center (ARCC) at the University of Central Florida houses high performance computing resources for use in research by faculty across campus. Research supported by the ARCC covers a variety of different disciplines, including Engineering, Modeling and Simulation, Optics, Nanoscience, and many others. The ARCC staff also pursues research in machine learning and visualization, as well as information technology. Currently, the center houses a high performance computing system known as Stokes, which is used to help support and drive research within the university.

[05/02/2017], Shandong University, , China Founded in 1901, Shandong University, based in Jinan, China, is the nation’s largest public university. It has prepared over 400,000 individuals in a variety of specialties, and has been making significant contributions to the country’s economic and social development. The growth of the university has allowed it to rise to the forefront of many fields in China. They continually develop new disciplines such as crystal materials, cardiovascular functional recovery, and new drug manufacturing to stay on the cutting edge of scientific research. Many of these newly formed disciplines have quickly risen to the first-class level within the country, and some are even know abroad.

[02/17/2017], University of Porto, Praça de Gomes Teixeira, Portugal The University of Porto, founded in 1911, is a leading scientific and research institution located in Portugal. The university is internationally recognized for the quality of research it produces, and is consistently ranked among the 150 best European universities. It is an important driver of economic, social, and scientific development within Portugal, and strives to be a strong partner of the business community. By combining quality teaching with a focus on market needs, the university strives to actively participate in, and encourage, the progress of communities in which it operates.

[05/24/2016], Marche Polytech University, Ancona, Italy The Department of Life and Environmental Sciences was established in 2011 by merging a number of laboratories involved in a wide spectrum of fundamental and applied research topics. The department is a center of excellence of the Università Politecnica delle Marche and includes more than 100 scientists and technicians that conduct research in areas such as analytical and organic chemistry, biophysics, cellular and molecular biology, biochemistry and genetics, microbiology and biotechnology, viral, prokaryotic, fungal, algal, plant and animal systematics, physiology and reproduction, marine biology, ecology, eco-toxicology, oceanography, Earth sciences, risk reduction and civil protection.

[05/12/2016], University of Buenos Aires, Buenos Aires, Argentina Buenos Aires University consists of thirteen colleges/schools, dozens of research institutes, and two secondary schools, offering more than 100 undergraduate majors. There is a teaching staff of 30,000 teachers, and approximately 300,000 students; 30% of scientific research in Argentina takes place at UBA. Standard undergraduate studies last approximately 5 years. Buenos Aires University offers several graduate programmers, masters, PhDs, and specialization courses as well.

[05/12/2016], Queen's University, Kingston, Canada The mission of Queen's University has been articulated in a number of different forms and formats over the past decade. In all of the presentations, the key elements have remained constant: The University will build on the strength that is Queen's - students, faculty, staff and alumni - to be among the best of internationally known universities in Canada, recognized for: •the exceptional quality of undergraduate and graduate students and programs in the arts, sciences and professions; •the intellectual power and value of research and scholarship by faculty members and students; •the exemplary service of the University and that of its graduates to the community and the nation and the community of nations.

[04/28/2016], University of Leuven, Leuven, Belgium KU Leuven is a research-intensive, internationally oriented university that carries out both fundamental and applied research. It is strongly inter- and multidisciplinary in focus and strives for international excellence. To this end, KU Leuven works together actively with its research partners at home and abroad.KU Leuven encourages personal initiative and critical reflection in a culture of idea exchange, cooperation, solidarity and academic freedom.

[03/07/2016], Mayo Clinic, Rochester, USA Mayo Clinic is the first and largest integrated nonprofit medical group practice in the world, employing more than 3,800 physicians and scientists, as well as 50,900 allied health staff. Based out of Rochester, MN, the Mayo Clinic’s mission is “to inspire hope and contribute to health and well-being by providing the best care to every patient through integrated clinical practice, education, and research.” The practice specializes in treating difficult cases through tertiary care, and spends over $500 million a year on research. It was also recognized as one of the best hospitals in the U.S. for 2015-2016 by U.S. News & World Report.

[03/02/2016], Czech Technical University, Prague, Czech Republic The Czech Technical University in Prague (CTU) is an internationally recognized higher education and research institution with more than 300 years of tradition and excellence. CTU is a leading technical research university with a large focus on cutting edge science and engineering, paired with a high-quality technical education. With 8 departments each focused on an engineering specialty, the university educates modern specialists, scientists, and managers who are dynamic, flexible, and able to rapidly adapt to the requirements of the market.

[02/10/2016], CERB, Baugy, France Located in Baugy, France, CERB was founded in 1973 and has developed into a leading international contract research organization (CRO) in the fields of pre-clinical pharmacology and toxicology. Taking on the challenges of modern drug development, CERB has created a distinctive image as a leading major service provider to the pharmaceutical industry in the context of innovative bio-medical research. CERB takes advantage of its sophisticated synergy between pharmacology and toxicology resources to provide complete pre-phase I packages for new molecules in an economic and timely manner

[01/07/2016], Goergen Institute for Data Science (GIDS), Rochester, USA The GIDS supports faculty research, particularly collaborative public-private research partnerships spanning several domains, such as developing health care breakthroughs, improving our knowledge of how the brain works, and creating tools and systems to efficiently use data. The GIDS is working to build strategic alliances and business partnerships among the academic, government, and business communities, leveraging University of Rochester expertise.

[10/06/2015], Dresden University of Technology, Dresden, Germany Dresden University of Technology is one of eleven German universities that were identified as an “excellent university", and includes over 37,000 students with 14 institutions offering a wide range of academic programs. The Institute of Biomedical Engineering focuses on the early detection, diagnosis, and treatment of life-threatening cardiovascular disease. With a strong focus on research.

[10/06/2015], Biomedical Systems, Maryland Heights, USA Biomedical Systems has set the health care industry standard by providing innovative approaches to non-invasive diagnostic services, clinical trials, and products. They provide their clients with the ability to increase cost efficiencies and bring studies to database lock on an advanced timeline by combining over 20 modalities in one study. Biomedical Systems' pioneering spirit is based on a strong history as a privately held company that focuses on clients and people.

[09/15/2015], VivaQuant LLC, Shoreview, USA VivaQuant provides products, services and technology that incorporate advanced signal processing to more accurately extract valuable information from biological signals. Through their technology they are committed to improving the lives of patients and the productivity of clinicians and researchers.

[08/04/2015], Sensium Healthcare Ltd, Abingdon, UK Sensium Healthcare, A global pioneer in wireless monitoring of vital signs. The company focus is on ultra-low power, lightweight, monitoring solutions which improve patient care and safety,shorten hospital stays and reduce healthcare costs.

[07/28/2015], Seoul National University, , South Korea, Seoul National University, As Korea leading research university, honoring the ideals of a liberal education aim at teaching students a lifelong love of learning that will form the basis for continuous personal growth. It includes 16 Colleges, 1 Graduate School, 9 Professional Graduate Schools with 16,006 Undergrad Students, 10,559 Graduate Students.

[07/16/2015], Boston Scientific, Marlborough, MA, USA A leading innovator of medical solutions that improve the health of patients around the world. Products and technologies used to diagnose or treat a wide range of medical conditions, including heart, digestive, pulmonary, vascular, urological, women health and chronic pain conditions. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world.

[09/30/2014], Harvard Medical School-Wyss Institute for Biologically Inspired Engineering, Boston, USA The Wyss Institute aims to discover the engineering principles that Nature uses to build living things, and harnesses these insights to create biologically inspired materials and devices that will revolutionize healthcare and create a more sustainable world. In medicine, the Institute is developing innovative materials, devices, and disease reprogramming technologies.

[03/12/2014], University Medicine Berlin, Berlin, Germany The Charite is one of the largest university hospitals in Europe. Here, 3700 doctors and scientists heal, do research and teach at the top international level. More than half of the German Nobel Prize winners in medicine and physiology come from the Charite, among them Emil von Behring, Robert Koch and Paul Ehrlich.

[01/23/2014], BioSign GmbH, Ottenhofen, Germany Developing innovative measurement and therapy systems for professionals and end-users in the subject area vegetative (autonomic) nervous system. BioSign is responding to the growing medical recognition that disturbances in the autonomic nervous system and disturbances in the interplay of the various organs are involved with the autonomic nervous system.

[11/14/2013], University of Rochester, Computer and Electrical Engineering, Rochester, USA This department has multiple programs related to energy, to health and medicine, to the connected world, and to music. Specific research programs span a wide range, including medical imaging, image processing, genomics, audio and music signal processing, among others.

[10/31/2013], RIT, Microsystem Engineering, Rochester, USA The multidisciplinary program builds on the fundamentals of traditional engineering and science including the manipulation of electrical, photonic, optical, mechanical, chemical, and biological functionality to process, sense, and interface with the world at a nanometer scale.

[09/10/2013], Medtronic, Inc., Medtronic , USA Medtronic develops and manufactures innovative medical device technology and therapies to treat chronic disease worldwide.

[06/11/2013], RIT, Department of Biomedical Engineering, Rochester, USA The RIT mission is to provide technology-based educational programs for personal and professional development. We rigorously pursue new and emerging career areas. We develop and deliver curricula and advance scholarship relevant to emerging technologies and social conditions. Our community is committed to diversity and student centeredness and is distinguished by our innovative and collaborative spirit.

[05/02/2013], Masonic Medical Research Laboratory, Utica, USA The Masonic Medical Research Laboratory is a not-for-profit institute dedicated to improving the health and quality of life for all. The Laboratory primary mission is to conduct high quality basic and clinical research aimed at generating knowledge and information necessary for development of the medical cures and treatments of tomorrow.

[04/22/2013], Universitat Politecnica de Catalunya (Barcelona-Tech), Barcelona, Spain. The Universitat Politecnica de Catalunya (UPC): BarcelonaTech is a public institution dedicated to higher education and research, specialised in the fields of engineering, architecture and science. With a focus on intellectual rigor, critical thinking, a transversal approach to knowledge, educational innovation and entrepreneurship, the UPC produces competent professionals with the skills they need to tackle present and future challenges.

[03/20/2013], Teschnische Universitat(TU), Berlin, Germany The TU Dresden is one of eleven German universities that were identified as an Excellence University. TUD has about 36.500 students and almost 5319 employees, 507 professors among them, and, thus, is the largest university in Saxony.

[02/08/2013], Baskir State Pedagogical University (BSPU), Uta, Russia M. Akmullah BSPU is a large scientific, educational, cultural and social center of the Republic of Bashkortostan. It includes the Institute of Pedagogics, the Institute of Professional Education and Information Technologies, the Institute of Historical and Legal Education, the Institute of Philological Education and Cross-Cultural Communication and 7 departments with about 12 000 students.

[02/01/2013], Chung-Yuan Christian University, Taiwan, China Chung Yuan Christian University is founded on the spirit of Christian love for the world. With faith, hope, and love, we endeavor to promote higher education for the benefit of the Chinese people, aiming at the pursuit and advancement of genuine knowledge in order to maintain our cultural heritage and, thus, to serve humankind.

[12/11/2012], Cardio-QT Ltd., Glasgow, UK Headed by Royal College Accredited Cardiologist and Bioengineer supported by PhD Scientists, Cardio-QT Ltd is an award winning, highly innovative Core Cardiac Analysis Laboratory offering an array of sophisticated validated techniques to solve all analytical research problems.

[10/21/2012], National Polytechnic Institute of Mexico, Santiago de Querétaro, Mexico The Institute is the State secular free education institution, guide of public technological education in Mexico. A leader in the generation, application, dissemination and transfer of scientific and technological knowledge.

[09/24/2012], Massachusetts General Hospital, Harvard Medical School, Boston, USA Mass General has long been a leader in successfully bridging innovative science with state-of-the-art clinical medicine. With an annual research budget of nearly $764 million, Mass General conducts the largest hospital-based research program in the United States - a program that spans more than 20 clinical departments and centers across the hospital. This funding drives discoveries and breakthroughs in basic and clinical research, which translate into new and better treatments that transform medical practice and patient care.

[05/24/2012], College of Veterinary Medicine, Cornell University, Ithaca, USA The mission of the Department of Biomedical Sciences is to educate and inform the veterinary and human biomedical communities through our diverse research and clinical service excellence as well as through our commitment to undergraduate, graduate, and veterinary teaching.

[05/02/2012], The Victor Chang Cardiac Research Institute (VCCRI), Darlinghurst NSW 2010, Australia The VCCRI is committed to excellence in research into heart disease and cardiovascular biology, cardiovascular research training, and facilitating the rapid application of research discoveries to patient care.

[02/09/2012], SAIT, Samsung Advanced Institute of Technology, Gyeonggi-do, Korea SAIT provides a full spectrum of support so its researchers can focus on creative research, seek the convergence of heterogeneous technologies and take up new challenges. Meanwhile, SAIT also actively engages in "open innovation" to jointly create future value with other research institutions through collaboration.

[01/26/2012], FDA-CDRH: Center for Devices and Radiological Health, Silver Spring, USA FDA Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. In addition, CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions.

[01/10/2012], Department of Physiological Nursing, University of California, San Francisco, USA The Mission of the Department of Physiological Nursing prevention of UCSF is to study the prevention, measurement, and treatment of physiological and biobehavioral responses to health, illness/disease and aging. Psycho-physiological interrelationships and interventions also are studied. Research spans all phases of the health/illness trajectory including people who are healthy, critically ill, living with a chronic illness, and those at the end of life.

[01/03/2012], University of Bologna (HST-ICIR), Bologna BO, Italy The University of Bologna was probably the first University in the western world. Its history is one of great thinkers in science and the humanities, making it an indispensable point of reference in the panorama of European culture. Bologna has thus been called upon to forge relationships with institutions in the most advanced countries to modernise and expand its activity. Among the many challenges which it has met with success, Bologna committed itself to the European dimension which has now led to adoption of the new university system.

PRESS CENTER

[09/23/2010]: AstraZeneca joins the THEW to further cardiac safety inThe Medical News: here .

[12/16/2009]: The Director of the THEW interviewed by Technology Review published by the MIT: here .

[11/11/2009]: New Research Center to Focus on Cardiac Safety and Innovation in Pharmaceutical Industry Today: here .

[6/11/2009]: University of of Rochester and FDA Partner for ECG Database, Drug Discovery & Development Magazine. More info here

[5/6/2009] FDA website Existing Partnerships FDAs Public-Private Partnership Program: THEW

[03/28/2009] Public and Private part- nership to help determine Clinical Biomarker Utility in Applied Clinical Trials online.com. >here

Newsletter Issue 13, 2012

Holter ECG from the Defibrillator in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) Study available in the THEW

Editorial: THEW ready to host Holter ECGs from Clinical trials: pioneering with the DEFINITE trial

by JP. Couderc, PhD, MBA

The purpose of the Defibrillator in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) Study was to determine if the combination of ICD therapy to optimal medical therapy reduces all-cause mortality in non-ischemic cardiomyopathy patients with low ejection fraction and NSVT/PVC's compared to optimal medical therapy only.

growth The enrolled patients in this trial had a diagnosis of nonischemic dilated cardiomyopathy, LVEF < 36%, and PVC's or unsustained ventricular tachycardia. The control group received standard medical therapy, while the test-ICD group received standard medical therapy and a single-chamber ICD. At 2 years, the mortality rate was greater in the control group (14.1%) than the test-ICD group (7.9%). There were significantly more sudden deaths from arrhythmia in the control group than there were in the test-ICD group (p=0,006). The investigators concluded that the combination of ICD therapy with standard optimal medical therapy reduced the risk of sudden death from arrhythmia in patients with severe non-ischemic dilated cardiomyopathy.

We are glad to announce that the Holter ECG recordings acquired in this trial are now hosted in the THEW and are available for research to our members. Two hundred and thirty six patients were enrolled in this study and got a Holter ECG recording acquired either at enrollment of later during the trial. The patients were followed for 29 months in average. The enrollment criteria included LVEF<36%, the presence of ambient arrhythmias, a history of symptomatic heart failure, and the presence of non-ischemic dilated cardiomyopathy. Ambient arrhythmias were defined by an episode of non-sustained ventricular tachycardia on Holter (3 to 15 beats at heart rate superior to 120 beats per minutes) (not the ECGs hosted in this database). The acquisition of the Holter recordings (hosted in the THEW) was initiated after the start of the trial. ECGs were acquired at baseline or at the next scheduled follow-up visit for patients who were already enrolled in the study. This data represents a unique opportunity to test ECG markers for risk of arrhythmic death in a group of patients with a documented cardiac history and valuable followup information.

The database consists of 401 24-hour Holter recordings recorded in 236 patients. One hundered and forty recordings were acquired at baseline, and the remaining were acquired during followup visit. More information about the database can be found on the database webpage of the THEW website. Importantly, we have designed a new type of research agreement with Northwestern University (Chicago, IL) in order to enable the distribution of the DEFINITE data to the Scientific community. A review committee consisting of individuals from the THEW and from the group which conducted the DEFINITE trial has been formed. Prof. A. Kadish and his collaborators will join the THEW review committee to review research proposals and ensure that any proposed scientific investigation can benefit from their experience with the data.  The official release date of this new database from our repository is March 1st, 2012. More information can be found here .

It is noteworthy that this new type of data sharing agreement represents a cornerstone for our intiative. We have built through this effort a legal platform welcoming data from large clinical trials while ensuring that principal investigators will remain involved in supporting the research activities of our members. We hope that this strategy will lead other Institutions that have conducted ground-breaking clinical research to join our endeavor.

In addition, we welcomed during this past quarter several new members. First, large ECG equipment companies such as Philips Healthcare and Samsung Electronic purchased the full access to our database. Second, the Center for Devices and Radiological Health has joined us as well. Finally, we present in this issue the work from Astra-Zeneca related to novel ECG markers to quantify the variability fo the T-wave. The technique was evaluated on data from the THEW as well, and the result of this investigation will be presented during the annual congress of the European Cardiac Arrhythmia Society in Munich this upcoming April.

All the THEW team hopes you will enjoy this long-expected new issue of our Newsletter, and wish you, with a bit of delay but a warm feeling, a Happy and Successful New Year 2012.

meeting

FDA: New Legal FDA-THEW Data Use Agreement, the FDA-CDRH joined the THEW initiative

THEW continues to feed the research activities at the FDA with ECG data. In May last year, the National Center for Toxicological Research (NCTR) gained access to several database from the THEW triggering the first official research project based on THEW data conducted at FDA. In this process, the agency released a new Data Use Agreement specifically designed for FDA employees. The document is available for download here . This past month, the Center for Devices and Radiological Health registered with THEW through this new legal agreement that will facilitate the access of the THEW data to FDA employees for research purposes. Dr. David Strauss, scientist and medical officer at FDA's Center for Devices and Radiological Health, working on differentiation of benign from malignant QT prolongation commented, "The THEW collection of databases is a tremendous resource for the research community, and access to the databases will help FDA perform regulatory science."

HL7 Annotated ECG format will be revamped to handle continuous ECGs: FDA will hold a public meeting in March.

The FDA will held a public meeting on Wednesday, March 14, 2012, from 8 a.m. to 5 p.m. at the FDA's White Oak Campus to discuss the new HL7 Annotated ECG data format developed to handle long-term ECG data from continuous recordings. This change was planned in order “to expand both the hardware and the software resources of the FDA's ECG Warehouse. FDA is interested in the perspective of manufacturers, ECG laboratories, investigators, industry, and academic researchers as it seeks to improve the collection, analysis, submission, and review of continuous ECG recordings for purposes of assessing drug safety”.
During this meeting, Mortara Instrument will describe several new analytic features of the FDA warehouse and the proposed modifications of the current HL7 aECG format in order to handle continuous ECG recordings and their associated beat annotation information. Barry Brown, Product Integration Manager at Mortara Instrument, commented: “The current HL7 aECG format is unpractical for storing large amount of information such as the ones available in 24-hour Holter recordings. For instance, a continuous 48-hour 12-lead recording (recorded with high resolution i.e. 1 sample every millisecond) could require up to 10 GB of storage space. Thus, Mortara Instrument will propose to insert links to binary files inside the HL7 aECG file to efficiently store and access these information.“
This new feature will be possible by inserting XML tags describing the attributes of the binary file (binary structures, signal data organization, etc.) in the current HL7 aECG structure. Such solution seems very attracting since it provides flexibility to ECG device companies to fit in their existing format. The ISHNE format used in the THEW is one of them. Interestingly, the format will also ensure that standard compression schemes could be used.
Today, various computerized tools are available to measure beat-to-beat intervals from continuous ECG signals (i.e. P onset , QRS onset, T-wave end, etc.). The storage of these measures in 100,000 to 150,000 cardiac beats per 24-hour makes the current XML HL7 aECG format very unpractical. So, Mortara Instrument will propose to insert a second link to an annotation file in binary format. The structure of this file will be flexible as well, it has been described by Barry Brown as a file containing "the beat number in each row and a list of fiducial points stored in each column with no limitation on the number of columns".
The revamping of the HL7 aECG have been wisely crafted by Mortara Instrument team in collaboration with regulators. The discussions that will occur in March are going to be interesting. Ultimately they should lead to improve the analysis of ECG acquired in drug safety studies by providing the ability to regulators and other stakeholders to better assess the confounding effects of a large spectrum of factors on ECG markers used in drug safety.

Official FDA notice for the public meeting is available for download here

TECHNICAL CORNER: THEW ECG viewer and algorithm library

All the ECG data currently hosted in the repository are stored using a single type of format: the ISHNE format. This format is described in our website. To facilitate the access to the raw signals, we have opened a library of codes to read these signals and annotation information. These procedures are available for download in our webiste in order to facilitate anyone with a minimum of coding experience to integrate this code into their development platform. As of today, c++ and MATLAB codes are provided, and we planned to regularly update tools in a common interest of facilitating the access and analysis of the data from our repository.image

EXPERT OPINIONS: the Delta-50 method.

By Christina Abrahamsson PhD, Corina Dota MD, Bo Skallefell BSc, Leif Carlsson PhD, Nils Edvardsson MD PhD, Göran Duker PhD, AstraZeneca R&D, Göteborg, Sweden.

Increased beat-to-beat variability in cardiac repolarization time is a tentative risk marker of drug-induced torsades de pointes. Evaluation of its value as a risk marker requires automatic measurements of the repolarization time on single beats, which is truly a challenge, especially when the ECG signal is noisy or of low amplitude. The deltaT50 method measures the beat-to-beat variability of the “T50-interval”, the time from the intersection of the RS line and the isoelectric line to 50% of the T wave downslope (Fig. 1). Noise reduction of the T wave downslope is achieved by using 21 points smoothing (Fig 2). The deltaT50 algorithm is incorporated in a special version of EClysis used for research properties. It enables automatic, operator-independent measurements on ECG signals with a signal-to-noise ratio (SNR) of at least 10 if beats following changes in the RR interval exceeding 150 ms are excluded and if 9 beat pairs are available for analysis.

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FIGURE 1:

Figure 1 The deltaT50 method measures the beat-to-beat change in the “T50 interval”, i.e. from the intercept between the RS  and isoelectric lines to 50% of the T wave downslope


The reason for choosing the start of the T50 interval at the intersection of the RS  and isoelectric lines was that this point is easier to determine automatically than the start of the QRS complex. The idea of measuring the interval, not to the end of the T wave (which is also  very difficult to define), but to 50% of the T wave downslope, arose from what can be seen on superimposed, consecutive ECG complexes, namely that the whole T wave downslope appears to shift in parallel when the QT interval changes beat by beat. This was also confirmed from measurements of the variability at 20 and 80% of the T wave downslope. However, deltaT50 was chosen as the primary variable, since tentative errors in the estimation of the maximum and minimum of the T wave downslope, which may occur due to noise, have a smaller effect on the interval at the steep 50% level than at the flatter 20 and 80% levels.
A study in 10 young, healthy subjects was initially undertaken to establish the proper conditions for the measurements of deltaT50, i.e. to investigate the effect of smoothing, the effect of added noise to the ECG signal, the relationship between changes in the RR and T50 intervals and the least number of beats for a reliable estimation of deltaT50. Recordings from another 32 subjects, 18 to 68 years old, were included to investigate whether measurements of deltaT50 should be corrected for age, heart rate (HR), T wave amplitude, heart rate variability (deltaRR) or QTcF.

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FIGURE 2:

Figure 2. The effect of noise and smoothing on deltaT50 was studied by adding noise of increasing amplitude to noise-free ECG signals. In these examples, sinusoidal (upper panel) or white noise (lower panel) was added, resulting in a signal-to-noise ratio of approximately 10 and a substantial increase in deltaT50. However, both the appearance of the ECGs and deltaT50 were normalized after 21 points of smoothing.


Smoothing is an efficient tool to iron out wrinkles on the ECG signal (Fig. 2). We started by investigating the effect of smoothing on noise-free signals and found that not even 21 points smoothing significantly altered deltaT50. When sigmoidal or white noise was added to the signals, deltaT50 increased in proportion to the amplitude of the added noise. However, 21 points smoothing restored the shape of the signal (Fig 2), and deltaT50 could be measured with high precision on signals with a SNR before smoothing of at least 10.
The beat-to-beat changes in the T50 interval were very small in the healthy subjects, on average 1.5 ms, but, as expected, large changes in the RR interval resulted in larger changes in the T50 interval (Fig 3A). To avoid the effect of these large changes in RR, which were only seen in the subjects with pronounced sinus arrhythmia, we decided to exclude all beat pairs where RR changed more than 150 ms (Fig 3B). This reduced the variability in deltaT50 both between and within the subjects, and a reliable estimation of deltaT50 could be done on only 9 beat pairs. We found no correlation between deltaT50 and age, gender, T wave amplitude, SNR or QTcF, but significant correlations to both HR and deltaRR. However, differences in HR and deltaRR explained only 2.6 and 3.5%, respectively, of the within subject variability, and only 10 and 19%, respectively, of the variability in deltaT50 between subjects. We therefore decided to measure deltaT50 without correction for any of these tentatively confounding factors.
The average deltaT50 was 1.5±0.41 ms in the 42 subjects, ranging from 0.86 to 2.84 ms, and correlated well between repeated measurements in the same subject.

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FIGURE 3:

Figure 3. Panel A shows the beat-to-beat changes in the T50 interval (deltaT50) versus the change in the preceding RR interval (deltaRR) for all single beats recorded during 10 min of rest in 10 young, healthy subjects (one symbol/subject). With the deltaT50 method, all beats following a change in the RR interval of more than 150 ms are excluded, since not all subjects display this large RR variability, and, if so, only occasionally. When deltaRR ranged between 0 and 150 ms, deltaT50 seldom exceeded 4 ms (Panel B), and the average deltaT50 was 1.5 ms in this interval.

 

To summarize, the deltaT50 method can be used to measure beat-to-beat variability in cardiac repolarization time without corrections for age, gender, T wave amplitude, SNR, HR, deltaRR or QTcF.

The paper describing the method was recently published in Journal of Electrocardiology (please click here ).

Since AstraZeneca joined the THEW initiative last year, the deltaT50 method has been applied to the Holter ECGs from the healthy volunteers and the patients with Long QT Syndrome. The THEW data will be used for further validation of the technology and to strengthen the link between increased repolarization variability and arrhythmia risk.