Heart Pumps News
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Puzzle Medical to Present at AHA 2022 its First-in-Human Study Results
Puzzle Medical Devices Inc. is delighted to announce its first-in-human results for the ModulHeart have been presented at the prestigious American Heart Association (AHA) meeting held November 5–7, 2022 at the McCormick Place Convention Center in Chicago, IL. Montreal-based Puzzle Medical Devices Inc. (PMD) developed a percutaneous heart pump designed to support cardiac and renal function ...
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Puzzle Medical to Present at TCT 2022 Its First-in-Human Study Results for the ModulHeart™
Montreal-based Puzzle Medical Devices Inc. (PMD) developed a percutaneous heart pump designed to support cardiac and renal function in patients with advanced heart failure (HF). PMD announced it will present its first-in-human results for the ModulHeartTM in the following session during the Transcatheter Cardiovascular Therapeutics (TCT) meeting held September 16-19, 2022 at the Boston Convention ...
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CardioWise™ Receives ISO 13485:2016 Clearance for Design, Development, and Marketing of Software as a Medical Device (SaMD) For the Medical Device Industry
CardioWise, Inc., is pleased to announce that Perry Johnson Registrars, Incorporated has audited the CardioWise Quality Management System (QMS) and determined CardioWise is in conformance with ISO 13485:2016. Perry Johnson Registrars Certificate C2022-02910 was issued July 16, 2022, and represents the first step in the process of obtaining a CE mark and Medical Device Registration for the ...
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Puzzle Medical Announces the Successful Completion of its First-in-Human Study with its ModulHeart
Montreal-based Puzzle Medical Devices Inc., announced today the successful completion of the company’s ?rst-in-human study to evaluate the performance of its ModulHeart percutaneous heart pump designed to reduce cardiac afterload and improve renal perfusion in patients with advanced heart failure (HF). Four patients had ModulHeart deployed to provide circulatory support while undergoing ...
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Procyrion Selects Former Abbott/St. Jude Medical Group President Dr. Eric S. Fain as CEO
Procyrion, Inc., a medical device company developing a catheter-deployed micropump for the management of chronic heart failure, has named Eric S. Fain, MD as President and Chief Executive Officer effective immediately. The Board of Directors tapped Dr. Fain to build upon the foundation of innovative technology established over recent years and accelerate the progression of product development ...
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CardioWise Joins the Lucem Health Innovation Collaborative as a Founding Member
CardioWise® and Lucem Health™ announced that CardioWise has become a founding member of the Lucem Health Innovation Collaborative, a partner program designed to help AI/ML innovation move to the forefront of healthcare. The collaborative launched by Mayo Clinic along with other investing partners will help digital health innovators create, deploy, and commercialize transformational ...
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CorWave Wins 2021 Healthtech Award
CorWave, a French medtech company developing a nextgeneration heart pump, won the 2021 Healthtech Award in the Medtech category yesterday. Organized by France Biotech, the French professional association of healthtech entrepreneurs, the event rewards the companies that have made the biggest impact on the sector this year. 109 companies submitted applications for the 2021 Healthtech Awards. ...
By CorWave
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The Hitchhiker’s Guide to Survival Analysis
Survival analysis is the best thing in the world since sliced bread! However, in most machine learning circles, it’s pretty much synonymous with an “# it’scomplicated” relationship status. Survival Analysis is an Extremely Valuable Branch of Statistics We want our guide to better serve you as a straightforward go-to/how-to, eliminating any confusion. The guide provides a ...
By JADBio
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CorWave Attracts Global Talent, Strengthening Its Management Team in Preparation for Clinical Phase and Industrial Ramp Up
CorWave, a French medtech developing a next-generation heart pump, is recruiting top talent from throughout the world to strengthen its team. Two seasoned industry experts are joining the company: Paul Cornelison (USA) as Vice President, Regulatory Affairs, Quality Assurance and Clinical Affairs, and Michael Webb (Australia) as Vice President, Manufacturing. Paul Cornelison and Michael Webb have ...
By CorWave
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FDA Grants EBR Systems Breakthrough Device Designation Status for the WiSE Cardiac Resynchronization Therapy (CRT) System
EBR Systems, Inc., developer of the world’s only wireless cardiac pacing system for heart failure, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the WiSE CRT System for the treatment of heart failure. The FDA created this designation and its associated program in 2017 for certain devices providing more effective treatment ...
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CorWave Successfully Performed a 90-Day In Vivo Study on Its Revolutionary Cardiac Pump Synchronized With the Native Heart, Results Presented at ASAIO Meeting
CorWave, a French medical device company committed to the fight against heart failure, announced that it has successfully completed the first 90-day preclinical study to evaluate its left ventricular assist device (LVAD) operating synchronously with the native heart without the use of sensors. The results were presented at the American Society for Artificial Internal Organs (ASAIO) Annual Meeting ...
By CorWave
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CorWave Presents an Unprecedented Chronic In Vivo Study at the 41st Annual Meeting of the International Society of Heart and Lung Transplantation
CorWave, a French medical device company committed to the fight against heart failure, unveiled an unprecedented study on the performance of its implantable heart pump at the 41st Annual Meeting of the International Society for Heart and Lung Transplantation (ISHLT). The company presented the first ever study demonstrating sensorless synchronization of a pericardial pump with the native heart for ...
By CorWave
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World’s First Leadless Left Bundle Branch Area Pacing Implant Utilizing EBR Systems’ WiSE CRT System
EBR Systems, Inc., developer of the world’s only wireless cardiac pacing system for heart failure, today announced that Professor Pascal Defaye, Head of Rhythmology and Cardiac Stimulation Unit, CHU de Grenoble-Alpes, France, performed the world’s first successful Leadless Left Bundle Branch Area Pacing (LBBAP) implant performed utilizing the WiSE CRT System. LBBAP pacing has been ...
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Spotlight from Canada Economic Development on Puzzle Medical`s journey
The idea of developing a minimally invasive heart pump arose during an entrepreneurship course at the École de technologie supérieure (ÉTS) being taken in 2018 by two mechanical engineering and robotics students, Jade Doucet-Martineau and François Trudeau, and during a discussion on the subject with a colleague, Dr. Gabriel Georges. Together, they observed that current ...
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CorWave Raises €35 Million in Series C Funding for Its Breakthrough Heart Pump; EIC Fund Joins as New Investor
CorWave raises 35 million euros to fund the next stages of its development, with the ambition to become a world-class medtech company serving heart failure patients. The capital increase is subscribed by returning investors joined by the EIC Fund, the European Commission's venture capital mega-fund, which makes its first investment. CorWave, located in Clichy, Île-de-France, is developing ...
By CorWave
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Second Heart Assist Files Patent for Electro-Activated Shape Changing Impeller for Circulatory Assist Devices
Salt Lake City, Utah and Irvine, CA Nov. 17th, 2020 (PR Distribution) — Second Heart Assist, Inc. has filed a patent application with the United States Patent and Trademark Office (USPTO) covering numerous claims for the utilization of electro-active polymers and shape-memory nitinol in combination or on a stand alone basis to control, with electro-magnetic energy on demand, the shape and ...
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Second Heart Assist Announces Successful Completion of Long-Duration Pre-Clinical Studies
NEWS PROVIDED BY Second Heart Assist, Inc. June 22nd, 2020 7:00am ET Salt Lake City, Utah, June 22nd, 2020 /PRDistribution/ — Second Heart Assist Inc., inventors of the first, true, aortic stent-based circulatory assist pump intended primarily for use in heart failure patients, announces the successful completion of a series of long-duration preclinical studies in pulsatile mock loop and ...
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EBR Systems Closes $30M in New Funding, John McCutcheon Joins Company as President and CEO
EBR Systems, Inc., developer of the world's only wireless cardiac pacing system for heart failure, today announced it has closed $30M in new funding to complete enrollment of its pivotal SOLVE CRT clinical trial and to prepare for commercialization of the WiSE Cardiac Resynchronization Therapy (CRT) System. This financing was led by Australian private equity firms Brandon Capital Partners and ...
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CardioWise Stretch Quantifier for Endocardial Engraved Zones (SQuEEZ) Receives Patents from Both the United States and the European Union
CardioWise, Inc., is pleased to announce two significant patents protecting its heart function analysis software, Stretch Quantifier for Endocardial Engraved Zones (SQuEEZ). The European Union Patent Number 12839978.9 was awarded on February 2, 2019, followed closely by the U.S. Patent on June 7, 2019 (patent application number 14/350,991). Both patents are entitled “Methods for Evaluating ...
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Dr. Mary Norine Walsh Joins SOLVE CRT Clinical Study as Co-Principal Investigator
EBR Systems, Inc., developer of the world's only wireless cardiac pacing system for heart failure, today announced that Dr. Mary Norine "Minnow" Walsh has become Co-Principal Investigator (Co-PI) of the SOLVE CRT clinical study. The SOLVE CRT (Stimulation of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy) clinical study is a prospective randomized, double blinded pivotal ...
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