The development of technologies for wearable health monitoring devices has experienced a strong momentum around new types of systems which are blurring the frontier between clinical and wellness devices. Their design lowers the usability constraints (wearable and miniaturization) and increases the monitoring duration; hence, delivering new insights into disease progression and patients’ status. To be efficient, these devices require either on-board or offline algorithms for delivering the analysis of the hundreds of thousands of cardiac beats recorded on a daily basis. Therefore, the technologies for automatic interpretation of the ECG signal are likely to be under a growing demand and their reliability to be increasingly scrutinized by regulatory bodies. The current requirements for the validation of novel Ambulatory ECG annotation algorithms rely on a very limited set of digitized ECG recordings from a couple of ECG databases built in the first half of the 70’s as described in the AAMI/ANSI-EC57 and IEC60601-2-25 Standard documents. These reference signals are obsolete.
This MADAE initiative is developing a validation dataset for computerized methods designed to detect and monitor cardiac activities based on body-surface ECGs. The MADAE data includes a new “high-density” annotation framework described in the Telemetric and Holter ECG Warehouse (here). The MADAE includes more than 1,200 recordings of duration varying from 15 min to 6 hours (600 ECGs used for evaluation). The MADAE is in its pre-qualification phase for becoming a Medical Device Development Tool (MDDT) approved by the United States Food and Drug Administration (FDA). It is part of the category called “ Nonclinical Assessment Models” , see figure above.
We open on December 1st 2019, a patronage program to give an opportunity of ECG-device company to be involved in the completion of our MADAE tool. That is an opportunity for stakeholders in the field to be involved in the completion of this project. The program is limited to include five patron organizations which will:
1. Get your organization name and logo on the MADAE webpage of the Telemetric and Holter ECG Warehouse which has shared data with more than 90 universities and 25 companies worldwide during the past 10 years (see www.thew-project.org).
2. Gain access to one seat to the round-table discussions with the FDA regulators on the completion of the MADAE database and its processes.
3. Gain open access to the data of the MDDT MADAE (v1.0).
4. Get first submission and evaluation of your technology free of charge.
If your organization is interested in becoming patron to this initiative please contact Jean-Philippe Couderc by email at
jean-philippe.couderc@heart.rochester.edu
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 |
06/27/2022, Punjabi University Patiala, Punjab, India |
06/01/2022, Kestra Medical Technologies, Inc., Kirkland, USA |
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 |
02/20/2020, Monash University, Melbourne, Australia |
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 |
11/11/2019, Tianjin University of Technology, Tianjin , CHINA |
11/01/2019, Parsons Government Service, HOUSTON, USA |
10/31/2019, University of Liverpool, Liverpool, UK |
10/31/2019, Air University Islamabad, Islamabad, Pakistan |
05/15/2019, University of Wisconsin, Madison, USA |
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 |
05/15/2019, Technion , Haifa, ISRAEL |
05/15/2019, Tampere University of Technology, Tampere, FINLAND |
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 |
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 |
05/15/2019, Argentine Institute of Mathematics, Buenos Aires , ARGENTINA |
05/15/2019, INESC TEC, Porto, PORTUGAL |
05/15/2019, Fraunhofer HHI, Berlin, GERMANY |
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 |
05/15/2019, Beth Israel Deaconess Medical Center, Boston, USA |
[01/24/2018], Biological Research Center of the Hungarian Academy of Sciences, Szeged, Hungary |
[01/02/2018], Universidade Federal do Maranhão, São Luís - MA, Brazil |
[03/12/2018], University of Vigo, Viigo, Spain |
[01/24/2018], Stanford Medicine, Stanford, USA |
[01/24/2018], The Austrian Research Institute for Artificial Intelligence, Vienna, Austria |
[10/25/2017], University of Tennessee Health Science Center, Memphis, USA |
[10/24/2017], Dankook University, Yongin-si,, South Korea |
[09/28/2017], Chinese PLA General Hospital, Beijing, China |
[07/20/2017], University of Central Florida, Orlando, USA |
[05/02/2017], Shandong University, , China |
[02/17/2017], University of Porto, Praça de Gomes Teixeira, Portugal |
[05/24/2016], Marche Polytech University, Ancona, Italy |
[05/12/2016], University of Buenos Aires, Buenos Aires, Argentina |
[05/12/2016], Queen's University, Kingston, Canada |
[04/28/2016], University of Leuven, Leuven, Belgium |
[03/07/2016], Mayo Clinic, Rochester, USA |
[03/02/2016], Czech Technical University, Prague, Czech Republic |
[02/10/2016], CERB, Baugy, France |
[01/07/2016], Goergen Institute for Data Science (GIDS), Rochester, USA |
[10/06/2015], Dresden University of Technology, Dresden, Germany |
[10/06/2015], Biomedical Systems, Maryland Heights, USA |
[09/15/2015], VivaQuant LLC, Shoreview, USA |
[08/04/2015], Sensium Healthcare Ltd, Abingdon, UK |
[07/28/2015], Seoul National University, , South Korea, |
[07/16/2015], Boston Scientific, Marlborough, MA, USA |
[09/30/2014], Harvard Medical School-Wyss Institute for Biologically Inspired Engineering, Boston, USA |
[03/12/2014], University Medicine Berlin, Berlin, Germany |
[01/23/2014], BioSign GmbH, Ottenhofen, Germany |
[11/14/2013], University of Rochester, Computer and Electrical Engineering, Rochester, USA |
[10/31/2013], RIT, Microsystem Engineering, Rochester, USA |
[09/10/2013], Medtronic, Inc., Medtronic , USA |
[06/11/2013], RIT, Department of Biomedical Engineering, Rochester, USA |
[05/02/2013], Masonic Medical Research Laboratory, Utica, USA |
[04/22/2013], Universitat Politecnica de Catalunya (Barcelona-Tech), Barcelona, Spain. |
[03/20/2013], Teschnische Universitat(TU), Berlin, Germany |
[02/08/2013], Baskir State Pedagogical University (BSPU), Uta, Russia |
[02/01/2013], Chung-Yuan Christian University, Taiwan, China |
[12/11/2012], Cardio-QT Ltd., Glasgow, UK |
[10/21/2012], National Polytechnic Institute of Mexico, Santiago de Querétaro, Mexico |
[09/24/2012], Massachusetts General Hospital, Harvard Medical School, Boston, USA |
[05/24/2012], College of Veterinary Medicine, Cornell University, Ithaca, USA |
[05/02/2012], The Victor Chang Cardiac Research Institute (VCCRI), Darlinghurst NSW 2010, Australia |
[02/09/2012], SAIT, Samsung Advanced Institute of Technology, Gyeonggi-do, Korea |
[01/26/2012], FDA-CDRH: Center for Devices and Radiological Health, Silver Spring, USA |
[01/10/2012], Department of Physiological Nursing, University of California, San Francisco, USA |
[01/03/2012], University of Bologna (HST-ICIR), Bologna BO, Italy |
[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