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Heart Function Articles & Analysis

34 news found

Corify Care Receives FDA Clearance for ACORYSยฎ โ€” Real-Time, 4-D Electroanatomical Cardiac Mapping

Corify Care Receives FDA Clearance for ACORYSยฎ โ€” Real-Time, 4-D Electroanatomical Cardiac Mapping

MADRID, Spain โ€“ April, 2026 โ€” Corify Care today announced that the U.S. Food and Drug Administration (FDA) has granted clearance for the ACORYSยฎ System, the first imageless, non-invasive cardiac mapping platform capable of delivering a global, four-chamber view of cardiac electrical activity in real time.The milestone represents a fundamental shift in electrophysiology by combining ...

ByCorify Care SL


Bodyport Announces Appointment of Jim Pursley to Board of Directors

Bodyport Announces Appointment of Jim Pursley to Board of Directors

Bodyport, a biomarker-guided digital therapeutics company on a mission to address complex chronic conditions, announced today the appointment of Jim Pursley to the company’s board of directors. “I am excited to join the Bodyport Board of Directors as they reimagine care for patients living with complex chronic conditions. Bodyport’s focus on the patient has driven them to ...

ByBodyport Inc.


Bodyport Receives FDA Clearance for the Bodyport Cardiac Scale

Bodyport Receives FDA Clearance for the Bodyport Cardiac Scale

Bodyport, a digital therapeutics company on a mission to address complex chronic conditions, announced today that its noninvasive biomarker platform, the Bodyport Cardiac Scale™ received U.S. Food & Drug Administration (FDA) 510(k) clearance. This innovative solution enables people with fluid management conditions, such as heart failure and kidney disease, to noninvasively assess ...

ByBodyport Inc.


Assessing Heart Function and Fluid Status with Cardiac Scales: Interview with John Lipman, CEO, and Corey Centen, Founder, Bodyport

Assessing Heart Function and Fluid Status with Cardiac Scales: Interview with John Lipman, CEO, and Corey Centen, Founder, Bodyport

Bodyport, a medtech company based in San Francisco, developed the Bodyport Cardiac Scale, a set of weighing scales that can non-invasively assess fluid status and heart function. The scales can detect these signals through the feet when a patient steps onto the device. The technology is intended to be convenient and requires only 20 seconds each morning, and should easily lend itself to ...

ByBodyport Inc.


Sequana Medical completes enrollment in Phase 2a SAHARA I DSR study, reports disease-modifying profile for Short Term DSR and provides business update

Sequana Medical completes enrollment in Phase 2a SAHARA I DSR study, reports disease-modifying profile for Short Term DSR and provides business update

DSR (Direct Sodium Removal) heart failure drug development: Completed enrollment in SAHARA I[i] with first-generation DSR product (“DSR 1.0”) – extending study with second-generation DSR product (“DSR 2.0”) to support US IND[ii] filing by year end Proof-of-concept delivered in diuretic-resistant heart failure patients with dramatic and durable improvements in ...

BySequana Medical NV


Ancora Heart Receives Breakthrough Device Designation from FDA for the AccuCinch Ventricular Restoration System

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 ...

ByAncora Heart, Inc


Bodyport Appoints John Lipman as Chief Executive Officer

Bodyport Appoints John Lipman as Chief Executive Officer

Bodyport, a biomarker-guided digital therapeutics company on a mission to address complex chronic conditions, today announced the appointment of medtech industry veteran, John Lipman, as Chief Executive Officer. Bodyport co-founder, Corey Centen, will continue as President and also serve as Chief Technology Officer (CTO) of the company. Lipman’s appointment comes as Bodyport prepares for ...

ByBodyport Inc.


CVRx Receives MR-Conditional Labeling Approval for its Barostim Heart Failure System

CVRx Receives MR-Conditional Labeling Approval for its Barostim Heart Failure System

MINNEAPOLIS, MAY 9,2022 - CVRx, Inc. (NASDAQ: CVRX) ("CVRx"), developer of the world's first FDA-approved neuromodulation device to treat the symptoms of heart failure, has received U.S. Food and Drug Administration (FDA) approval for magnetic resonance (MR) conditional labeling for its Barostim System. The Barostim System now includes instructions to allow for safe MRI scans of the head and ...

ByCVRx


BioCardia Receives FDA Breakthrough Device Designation for CardiAMP Cell Therapy System for Heart Failure

BioCardia Receives FDA Breakthrough Device Designation for CardiAMP Cell Therapy System for Heart Failure

BioCardia®, Inc. (Nasdaq: BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the CardiAMP® Cell Therapy System for the treatment of heart failure. It is believed to be the first cardiac cell therapy to ...

ByBiocardia, Inc.


EchoNous Partners with Us2.ai for Machine Learning-enabled Analysis of Heart Scans

EchoNous Partners with Us2.ai for Machine Learning-enabled Analysis of Heart Scans

EchoNous, the leader in ultra-portable, AI-guided point-of-care ultrasound (POCUS) tools and software, announced that the company has partnered with Singapore-based Us2.ai, developers of machine learning-driven software that automates the analyses of echocardiographic imagery and measurements. Us2.ai’s technology received FDA approval on July 27, 2021 Us2.ai’s software is being ...

ByEchoNous, Inc.


Xeltis initiates first-ever pivotal trial of a synthetic restorative pulmonary heart valve

Xeltis initiates first-ever pivotal trial of a synthetic restorative pulmonary heart valve

Xeltis, a clinical-stage company with the most advanced polymer-based restorative cardiovascular devices, today announced that it has started the first-ever pivotal trial for a synthetic restorative pulmonary valve. To date, pediatric patients requiring right ventricular outflow tract (RVOT) reconstruction have been successfully implanted as part of the global, FDA-approved Xplore2/Pivotal study. ...

ByXELTIS BV


ELIXIR MEDICAL EXPANDS BIOADAPTOR RANDOMIZED CONTROLLED TRIAL OF DYNAMX CORONARY BIOADAPTOR SYSTEM

ELIXIR MEDICAL EXPANDS BIOADAPTOR RANDOMIZED CONTROLLED TRIAL OF DYNAMX CORONARY BIOADAPTOR SYSTEM

MILPITAS, Calif. – April 22, 2021 – Elixir Medical, a developer of innovative, drug-eluting cardiovascular devices, today announced that the BIOADAPTOR randomized controlled trial (RCT) is expanding to centers in Belgium and Germany. The BIOADAPTOR RCT is evaluating the DynamX™ Coronary Bioadaptor System, the first drug-eluting coronary artery implant that adapts to vessel ...

ByElixir Medical Corporation


ELIXIR MEDICAL ANNOUNCES COMMENCEMENT OF INFINITY-SWEDEHEART RANDOMIZED CONTROLLED TRIAL OF DYNAMX CORONARY BIOADAPTOR SYSTEM

ELIXIR MEDICAL ANNOUNCES COMMENCEMENT OF INFINITY-SWEDEHEART RANDOMIZED CONTROLLED TRIAL OF DYNAMX CORONARY BIOADAPTOR SYSTEM

2,400-Patient Trial Utilizes Globally-Respected SWEDEHEART Registry Database in Randomized Study of First Metallic Device Treating Coronary Artery Disease That Adapts to Vessel Physiology MILPITAS, Calif. – March 16, 2021 – Elixir Medical, a developer of innovative, drug-eluting cardiovascular devices, today announced commencement of the INFINITY-SWEDEHEART randomized ...

ByElixir Medical Corporation


Berlin Heart Today Announces CE Approval and First Implantation of an Innovative Bridging Solution for Single Ventricle Patients

Berlin Heart Today Announces CE Approval and First Implantation of an Innovative Bridging Solution for Single Ventricle Patients

Berlin, March 2021: With the first-in-man implantation of the Berlin Heart Venous Cannula at the LMU University Hospital Munich (Grosshadern), Germany, Berlin Heart offers patients with a failing Fontan circulation a unique chance to survive the waiting time for a donor heart. These patients are in a life-threatening condition: their health has deteriorated so much that they desperately need a ...

ByBerlin Heart GmbH


BioVentrix Receives 2021 NUB Status 1 Reimbursement Renewal in Germany for the Revivent TC TransCatheter Ventricular Enhancement System

BioVentrix Receives 2021 NUB Status 1 Reimbursement Renewal in Germany for the Revivent TC TransCatheter Ventricular Enhancement System

BioVentrix, Inc., a privately held medical device company focused on treating congestive heart failure (CHF) via Transcatheter based Ventricular Restoration (TCVR), today announced that the German Institute for Hospital Remuneration (InEK) has renewed the NUB Status 1 reimbursement designation in Germany for the Revivent TC™ TransCatheter Ventricular Enhancement System used in LIVE™ ...

ByBioVentrix, Inc.


ELIXIR MEDICAL ANNOUNCES FIRST PATIENT TREATED IN BIOADAPTOR RANDOMIZED CONTROLLED TRIAL OF DYNAMX CORONARY BIOADAPTOR SYSTEM

ELIXIR MEDICAL ANNOUNCES FIRST PATIENT TREATED IN BIOADAPTOR RANDOMIZED CONTROLLED TRIAL OF DYNAMX CORONARY BIOADAPTOR SYSTEM

International Trial to Compare Bioadaptor, a Novel Coronary Artery Implant Designed to Adapt to Vessel Physiology, with Traditional Drug Eluting Stents International Trial to Compare Bioadaptor, a MILPITAS, Calif. – January 13, 2020 – Elixir Medical, a developer of innovative, drug-eluting cardiovascular devices, today announced that the first patient has been treated ...

ByElixir Medical Corporation


BioVentrix Announces Jerry Estep, MD, as Co-Principal Investigator for ALIVE Pivotal Trial Studying a Transcatheter Device for Heart Failure

BioVentrix Announces Jerry Estep, MD, as Co-Principal Investigator for ALIVE Pivotal Trial Studying a Transcatheter Device for Heart Failure

BioVentrix, Inc., a privately held medical device company focused on treating congestive heart failure (CHF) via Transcatheter Ventricular Restoration (TCVR), today announced that heart failure specialist Jerry Estep, MD, of the Cleveland Clinic has been appointed co-principal investigator of the pivotal ALIVE Trial studying LIVE Therapy using the Revivent TC TransCatheter Ventricular ...

ByBioVentrix, Inc.


BOHS cautions that new research into occupational exposure to diesel for professional drivers highlights a COVID-19 dilemma with ventilation

BOHS cautions that new research into occupational exposure to diesel for professional drivers highlights a COVID-19 dilemma with ventilation

The British Occupational Hygiene Society, a scientific charity and the Chartered Society for Workplace Health Protection, is welcoming research published by Imperial College London’s DEMist project, which uses black carbon to track exposure of professional drivers to diesel exhaust. The study led by Dr Ian Mudway, Senior Lecturer at the MRC Centre for Environment and Health, Environmental ...

ByThe British Occupational Hygiene Society (BOHS)


BOHS cautions that new research into occupational exposure to diesel for professional drivers highlights a COVID-19 dilemma with ventilation

BOHS cautions that new research into occupational exposure to diesel for professional drivers highlights a COVID-19 dilemma with ventilation

BOHS welcomes new research by IOSH-sponsored Imperial College into occupational exposure to diesel for professional drivers, but cautions that it highlights a COVID-19 dilemma with ventilation. The British Occupational Hygiene Society, a scientific charity and the Chartered Society for Workplace Health Protection, is welcoming research published by Imperial College London’s ...

ByThe British Occupational Hygiene Society (BOHS)


Cardior Pharmaceuticals ยด Lead Compound Demonstrates Improvement of Heart Function in Chronic Heart Failure Mode

Cardior Pharmaceuticals ยด Lead Compound Demonstrates Improvement of Heart Function in Chronic Heart Failure Mode

Hanover, Germany, October 22, 2020 - Cardior Pharmaceuticals GmbH, a clinical-stage biotech company, focused on the development of noncoding RNA (ncRNA) therapeutics for patients with cardiovascular diseases, today announced a publication in the European Heart Journal (doi:10.1093/eurheartj/ehaa791) demonstrating that repeated treatment with its lead compound CDR132L is safe, improves cardiac ...

ByCardior Pharmaceuticals GmbH

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