Heart Wall Articles & Analysis
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CardioWise™ Acquires Worldwide Rights to Patent, and Software to Guide Cardiac Resynchronization Therapy Through License Agreement with Johns Hopkins Technology Ventures
CardioWise, Inc., is pleased to announce that the company has acquired the worldwide rights to Image Toolbox heart functional analysis software, and pending patent from Johns Hopkins Technology Ventures through a license agreement. The US Patent application was filed November 11, 2016. The software uses cardiac CT patient data sets to determine which heart failure patients may benefit from ...
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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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BioTrace Medical’s Tempo Lead Obtains CE Mark for Safe and Secure Temporary Intracardiac Pacing
BioTrace Medical, Inc., the leader in innovative temporary pacing technology, today announced the company’s Tempo Lead has obtained CE Mark certification in Europe for use in cardiac procedures requiring temporary intracardiac pacing. BioTrace Medical’s Tempo Temporary Pacing Lead is designed for safer, more secure and stable pacing to reduce intraprocedural complications, ...
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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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HTG Used for First Time in Congenital Heart Defect Surgery
It was another first for EchoPixel when its Holographic Therapy Guidance (HTG) was used in a congenital heart surgery at Cincinnati Children’s Hospital Medical Center. The procedure was conducted with a new mini 4D transesophageal echocardiography (TEE), which generates real-time ultrasound images and can be used in patients as small as 11 pounds. A life-saving procedure Complete ...
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Ancora Heart Receives Breakthrough Device Designation from FDA for the AccuCinch Ventricular Restoration System
Santa Clara, Calif.– July 12, 2022 – Ancora Heart, Inc., a company developing a novel device-based therapy to address heart failure, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the AccuCinch® Ventricular Restoration System. Currently being evaluated in the CORCINCH-HF pivotal clinical trial, the AccuCinch System ...
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Ancora Heart Receives IDE Approval for CorCinch-HF Pivotal Study of the AccuCinch Ventricular Restoration System
Santa Clara, Calif.– June 30, 2020 – Ancora Heart, Inc., a company developing a novel therapy to address heart failure, today announced U.S. Food and Drug Administration (FDA) approval of its Investigational Device Exemption (IDE) application for the CorCinch-HF pivotal study, which is designed to evaluate the safety and efficacy of the AccuCinch® Ventricular Restoration System in ...
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Vektor Medical to Present Positive Results from vMap Clinical Validation Study Showing 97.3% Mapping Accuracy for Atrial and Ventricular Arrhythmias
Non-invasive arrhythmia technology maps using only the data from a 12 lead ECG vMap provides actionable mapping results in minutes. Blinded, multi-center study with analysis by an independent core laboratory Results to be presented for the first time at Heart Rhythm 2022 Vektor Medical today announced positive results from its “Vektor vMap™ Clinical Validation ...
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Agreement signed with TELA Bio Inc
Next Science Limited (ASX:NXS) (Next Science) is pleased to announce that it has signed a multi-year distribution agreement with NASDAQ listed medical technology company, TELA Bio, Inc in relation to the supply of a white labelled version of Next Science’s proprietary XPERIENCETM No Rinse Antimicrobial Solution. The new agreement grants TELA Bio, Inc exclusive rights across the US plastic ...
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Elucid Raises $27 Million Series B Funding Round to Commercialize a New Paradigm in Heart Disease Diagnosis
BOSTON – June 22, 2022 – Elucid, a company developing a novel, non-invasive medical software to comprehensively characterize cardiovascular disease, announced the closing of a $27 Million Series B financing round. The round was led by an undisclosed strategic investor, with participation from Biovision Ventures, a new Europe-based fund, and existing investors, including MedTex ...
By Elucid
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