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Cardiac System Articles & Analysis

40 news found

Beyond Air® Reports Financial Results for the Second Quarter of Fiscal Year 2023

Beyond Air® Reports Financial Results for the Second Quarter of Fiscal Year 2023

“In addition, we are planning to submit a PMA supplement for an expanded cardiac label for the LungFit® PH system to the FDA.” “During the quarter, we presented positive data that support the development programs for the LungFit system using high dose NO as a potential treatment for several indications. ...

ByBeyond Air Inc


Cardiac telerehabilitation system implemented in Przemysl, southeast of Poland

Cardiac telerehabilitation system implemented in Przemysl, southeast of Poland

In times of pandemic, cardiac rehabilitation centres search for solutions which allow them to continue remote rehabilitation, while making it possible to maintain constant contact with the patient. ...

ByPro-PLUS SA


iRhythm Gains FDA Clearance for its Clinically Integrated ZEUS System

iRhythm Gains FDA Clearance for its Clinically Integrated ZEUS System

(NASDAQ:IRTC), a leading digital healthcare solutions company focused on the advancement of cardiac care, today announced it received FDA 510(k) clearance for its ZEUS (Zio ECG Utilization Software) System for the Zio Watch. Produced in partnership with Verily, an Alphabet precision health company, the ZEUS System combines deep learned algorithms ...

ByZio by iRhythm Technologies, Inc.


iRhythm launches Clinical Resource Center for clinicians’ convenience

iRhythm launches Clinical Resource Center for clinicians’ convenience

Evidence illustrating how the Zio service has helped healthcare systems improve cardiac patient care can be found in the case studies section of the CRC. ...

ByZio by iRhythm Technologies, Inc.


Acutus Medical completes enrollment in IDE trial with its AcQBlate FORCE Sensing Ablation System

Acutus Medical completes enrollment in IDE trial with its AcQBlate FORCE Sensing Ablation System

The company anticipates final patient follow-up in June 2022 with Pre-Market Approval (PMA) submission of the AcQBlate FORCE sensing ablation catheter and system in the third quarter of this year. Designed specifically to provide consistent, effective therapeutic solutions during cardiac ablation procedures, the AcQBlate FORCE system shows ...

ByAcutus Medical, Inc.


EBR Systems Raises AU$110M in Initial Public Offering on the Australian Securities Exchange (ASX)

EBR Systems Raises AU$110M in Initial Public Offering on the Australian Securities Exchange (ASX)

WiSE technology enables cardiac pacing of the left ventricle with a novel cardiac implant that is roughly the size of a large grain of rice. ...

ByEBR Systems, Inc.


Acutus Medical Initiates CE Mark Study for Focal Pulsed Field Ablation Therapy to Treat Atrial Fibrillation

Acutus Medical Initiates CE Mark Study for Focal Pulsed Field Ablation Therapy to Treat Atrial Fibrillation

(Nasdaq: AFIB) (“Acutus”), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced the initiation of AcQForce PFA-CE, a new clinical study that will evaluate the safety and performance of the company’s focal force sensing Pulsed Field Ablation (PFA) catheter and system in ...

ByAcutus Medical, Inc.


EBR Systems Appoints Dr Bronwyn Evans, Dr David Steinhaus and Ms Karen Drexler to the Board of Directors

EBR Systems Appoints Dr Bronwyn Evans, Dr David Steinhaus and Ms Karen Drexler to the Board of Directors

Highlights: Dr Evans, Dr Steinhaus and Ms Drexler to join EBR Systems’ Board ahead of the planned A$110m IPO on the Australian Stock Exchange Board appointments follow the retirement of Mr Dave Stassen and Dr Leighton Read New EBR Systems’ Board consists of Mr Allan Will, Mr John McCutcheon, Dr Christopher Nave, Mr Trevor Moody, Dr Bronwyn ...

ByEBR Systems, Inc.


EBR Systems’ WiSE CRT System Demonstrates Technical Feasibility of Leadless Left Bundle Branch Area Pacing for Cardiac Resynchronization

EBR Systems’ WiSE CRT System Demonstrates Technical Feasibility of Leadless Left Bundle Branch Area Pacing for Cardiac Resynchronization

“WiSE is the first and only leadless pacing system that can deliver physiologic, conduction system pacing without leads. ...

ByEBR Systems, Inc.


CytoSorbents Announces Availability of Preliminary Data Abstracts from Two Endocarditis Studies, including the REMOVE study, to be Presented at the EACTS Conference

CytoSorbents Announces Availability of Preliminary Data Abstracts from Two Endocarditis Studies, including the REMOVE study, to be Presented at the EACTS Conference

A summary of the abstracts are as follows: The REMOVE (“Revealing Mechanisms and Investigating Efficiency Of Hemoadsorption for Prevention of Vasodilatory Shock in Cardiac Surgery Patients with Infective Endocarditis“) investigator initiated randomized, controlled trial enrolled 288 patients with documented infective endocarditis with a EuroSCORE II (European ...

ByCytoSorbents Corporation


NIAID awards Phase I contract to Kephera Diagnostics for the development of a new test for Chagas disease

NIAID awards Phase I contract to Kephera Diagnostics for the development of a new test for Chagas disease

Infection can lead to chronic disease lasting decades, with a higher risk of death due to cardiac or digestive system impairment; up to one third of infections result in debilitating symptoms, while the remainder are asymptomatic. ...

ByKephera Diagnostics, LLC


Cardiac Dimensions Included in the New 2021 ESC Guidelines for Heart Failure Management

Cardiac Dimensions Included in the New 2021 ESC Guidelines for Heart Failure Management

Cardiac Dimensions, a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions, today announced the mention of their Carillon Mitral Contour System in the 2021 European Society of Cardiology (ESC) Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure. ...

ByCardiac Dimensions, Inc.


CorWave Attracts Global Talent, Strengthening Its Management Team in Preparation for Clinical Phase and Industrial Ramp Up

CorWave Attracts Global Talent, Strengthening Its Management Team in Preparation for Clinical Phase and Industrial Ramp Up

During his 30-year career, he has acquired a unique expertise in implantable cardiac devices. Former VP RAQACA of CardiAQ Valve Technologies, a transcatheter valve start-up acquired by Edwards Lifesciences for $350 million, he has also developed an extensive knowledge of cardiac assist devices (first at Arrow, then at Abbott as a consultant) and ...

ByCorWave


Galaxy Medical Enrolls First Patients in SPACE-AF Study SAN

Galaxy Medical Enrolls First Patients in SPACE-AF Study SAN

In the study, the CENTAURI Pulsed Electric Field (PEF) ablation system will be used to ablate both the pulmonary veins and posterior walls in patients with persistent atrial fibrillation (AF). Recently, Galaxy has also enrolled additional subjects in the ECLIPSE-AF study using the CARTO mapping system and CE-Marked catheters manufactured by Biosense Webster, ...

ByGalvanize Therapeutics, Inc.


FDA Grants EBR Systems Breakthrough Device Designation Status for the WiSE Cardiac Resynchronization Therapy (CRT) System

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. ...

ByEBR Systems, Inc.


Cardiac Dimensions Announces Launch of Its Optimized U.S. Pivotal Trial - The EMPOWER Trial

Cardiac Dimensions Announces Launch of Its Optimized U.S. Pivotal Trial - The EMPOWER Trial

” About the Carillon Mitral Contour System Cardiac Dimensions is reimagining the solutions available to patients suffering from heart failure (HF) by providing a therapy that allows patients to live longer, higher quality lives. ...

ByCardiac Dimensions, Inc.


The Ultimate List of Attractive MedTech M&A Targets

The Ultimate List of Attractive MedTech M&A Targets

The company’s pipeline also includes a system specifically for insulin-requiring people on once-a-day basal therapy, and a closed-loop automated insulin delivery pump-based system. ...

ByAnuncia Medical, Inc.


World’s First Leadless Left Bundle Branch Area Pacing Implant Utilizing EBR Systems’ WiSE CRT System

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) ...

ByEBR Systems, Inc.


Galaxy Medical Receives $18 Million from ATP to Advance Development of Its Novel Pulsed Electric Field Ablation Therapy for Cardiac Arrhythmias

Galaxy Medical Receives $18 Million from ATP to Advance Development of Its Novel Pulsed Electric Field Ablation Therapy for Cardiac Arrhythmias

GALAXY’S PROPRIETARY CENTAURI™ SYSTEM ON TRACK FOR EU REGISTRATION AND US PIVOTAL TRIAL START LATER THIS YEAR; SHOWS BEST-IN-CLASS POTENTIAL. ...

ByGalvanize Therapeutics, Inc.


FARAPULSE Receives European Approval To Commercialize Its Leading Pulsed Field Ablation System To Treat Paroxysmal Atrial Fibrillation

FARAPULSE Receives European Approval To Commercialize Its Leading Pulsed Field Ablation System To Treat Paroxysmal Atrial Fibrillation

("FARAPULSE" or "the Company") today announced that it has received the Conformite Europeene (CE) Mark for its FARAPULSE Pulsed Field Ablation (PFA) system for the treatment of Paroxysmal Atrial Fibrillation (AF). The approval makes FARAPULSE the first company in the world to commercialize a cardiac PFA system and permits marketing of the ...

ByBoston Scientific

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