CARDIOLOGY 2.0 – HeartSciences seeks FDA Approval for Innovative MyoVista wavECG Device

HeartSciences, a medical device company focused on advancing the field of electrocardiology through innovation, announced submission to the U.S. FDA via De Novo premarket review pathway for the MyoVista Wavelet ECG (wavECG) Cardiac Testing Device. The De Novo pathway is used for novel medical devices that are low to moderate risk.

Mark Hilz

“HeartSciences seeks to bridge today’s “diagnostic gap” in cardiac care through innovation in front-line ECG solutions that assist in the detection of heart disease in at-risk patients. Abnormal left ventricular relaxation is typically the earliest manifestation of diastolic dysfunction,” said Mark Hilz, HeartSciences’ CEO. “LV diastolic function is also now well understood to be impaired by all of the common heart disease processes that affect LV function. Thus, detecting impaired relaxation through the use of 12-lead ECG testing can be a game-changer for front-line heart disease testing.”

“This is an important milestone and the result of years of research and development focused on advancing the field of electrocardiography. Through the use of advanced technology, it is now possible to develop new algorithms focused on detecting cardiac states related to heart disease not previously detected by conventional ECG devices.” said Andrew Simpson, HeartSciences’ Executive Chairman.

South Lake, Texas-based HeartSciences’ request for De Novo classification is supported by clinical data collected in prospective, non-randomized, clinical studies conducted at three institutions which were aggregated into an overall clinical study dataset. The subject data (n=395 Validation Dataset) used to validate the performance of the wavECG Algorithm was not used in any aspect of the development of the wavECG Algorithms.

HeartSciences Announces De Novo Submission to FDA for Innovative MyoVista® wavECG™ Device

12 lead ECG device detects LV relaxation impairment associated with Left Ventricular Diastolic Dysfunction

 

SOUTHLAKE, TEXAS – December 9, 2019 – HeartSciences, a medical device company focused on advancing the field of electrocardiology through innovation, announced submission to the U.S. Food and Drug Administration (FDA) via De Novo premarket review pathway for the MyoVista® Wavelet ECG (wavECG™) Cardiac Testing Device. The De Novo pathway is used for novel medical devices that are low to moderate risk.

“HeartSciences seeks to bridge today’s “diagnostic gap” in cardiac care through innovation in front-line ECG solutions that assist in the detection of heart disease in at-risk patients. Abnormal left ventricular relaxation is typically the earliest manifestation of diastolic dysfunction,” said Mark Hilz, HeartSciences’ CEO. “LV diastolic function is also now well understood to be impaired by all of the common heart disease processes that affect LV function. Thus, detecting impaired relaxation through the use of 12-lead ECG testing can be a game-changer for front-line heart disease testing.”

“This is an important milestone and the result of years of research and development focused on
advancing the field of electrocardiography. Through the use of advanced technology, it is now possible to develop new algorithms focused on detecting cardiac states related to heart disease not previously detected by conventional ECG devices.” said Andrew Simpson, HeartSciences’ Executive Chairman.

HeartSciences’ request for De Novo classification is supported by clinical data collected in prospective, non-randomized, clinical studies conducted at three institutions which were aggregated into an overall clinical study dataset. The subject data (n=395 Validation Dataset) used to validate the performance of the wavECG Algorithm was not used in any aspect of the development of the wavECG Algorithms.

About HeartSciences and the MyoVista Device
HeartSciences’ MyoVista® Wavelet ECG (wavECG™) Cardiac Testing Device is a new resting 12-lead electrocardiograph that uses continuous wavelet transform (CWT) signal processing to extract additional frequency information from the acquired ECG signal. This new information is a key aspect of the MyoVista wavECG AI-based Algorithm that is designed to detect left ventricular (LV) relaxation abnormalities which are typically the earliest manifestation of left ventricular diastolic dysfunction (LVDD). Extensive research confirms that almost all forms and co-morbidities of heart disease are associated with LVDD including hypertension, diabetes, valvular disease, ischemia, and reduced systolic function.

The MyoVista wavECG Device is an innovative advancement for electrocardiographic testing designed to provide physicians with new information to improve patient risk-assessment related to heart disease and in determining whether a patient should receive further testing, evaluation and/or treatment.

The MyoVista Device additionally provides all the information and capabilities of a full-featured
conventional resting 12-lead ECG within the same test and follows the same clinical AHA/IEC lead placement protocol.

HeartSciences (formerly known as Heart Test Laboratories) is a privately held U.S. corporation based in Southlake, Texas.

For more information visit www.heartsciences.com.

Corporate contact
Gene Gephart
+1 737 414 9213
gene.gephart@heartsciences.com

 

MyoVista Wavelet ECG Cardiac Testing Device Showcased at 2019 ESC – Paris, France

MyoVista Wavelet ECG Cardiac Testing Device Showcased at 2019 ESC – Paris, France

HeartSciences, a medical device company developing next generation ECG devices using continuous wavelet transform (CWT) signal processing and artificial intelligence, is proud to have participated as an exhibitor at the 2019 European Society of Cardiology Congress (ESC) in Paris, France from August 31 to September 4, 2019. HeartSciences is advancing the field of electrocardiography through the application of wavelet signal processing and artificial intelligence to develop next generation ECG technology.

HeartSciences Named Among ‘50 Smartest Companies of the Year 2018’ by The Silicon Review Magazine

HeartSciences Named Among ‘50 Smartest Companies of the Year 2018’ by The Silicon Review Magazine

Southlake, Texas – Silicon Review, a leading Business and Technology magazine has named HeartSciences, as one of the 50 Smartest Companies of the Year 2018.

The Silicon Review 50 Smartest Companies of the Year 2018 program identifies companies that mastered the discipline of smartness and stood high among the crowd,” said Sreshtha Banerjee, Editor-in-Chief of The Silicon Review Magazine.

We are honored to be recognized by The Silicon Review Magazine as the one of the 50 Smartest Companies of 2018,” said Mark Hilz, CEO at HeartSciences. “HeartSciences use of patented signal processing methods combined with artificial intelligence is designed to bridge today’s “diagnostic gap” in cardiac care by providing low-cost effective solutions that help to identify cardiac dysfunction in the diastolic phase.”

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HeartSciences Showcases MyoVista® Wavelet ECG at 2018 European Society of Cardiology Congress (ESC)- Hall A, Booth G320

HeartSciences Showcases MyoVista® Wavelet ECG at 2018 European Society of Cardiology Congress (ESC)

Hall A, Booth G320

 

SOUTHLAKE, Texas, August 20, 2018 –(BUSINESSWIRE)—HeartSciences, a medical device company developing next generation ECG devices using continuous wavelet transform (CWT) signal processing and artificial intelligence is proud to announce its participation as an exhibitor at the upcoming 2018 European Society of Cardiology Congress (ESC). The Congress will take place at Messe Munich International in Munich, Germany and will run from August 25 to August 29, 2018. HeartSciences will highlight it’s MyoVista® Wavelet ECG (wavECG™) Cardiac Testing Device as well as recent clinical study results published in the Journal of the American College of Cardiology (JACC)

The JACC article titled “Prediction of Abnormal Myocardial Relaxation from Signal Processed Surface ECG” presented the results from the investigator-initiated clinical study that focused on evaluating the feasibility of MyoVista® Wavelet ECG as a diagnostic tool for predicting myocardial relaxation abnormalities. Results from the study demonstrate MyoVista’s patented technology based on CWT signal processing can detect myocardial relaxation abnormalities associated with LVDD.

About HeartSciences

HeartSciences is advancing the field of electrocardiography through the application of wavelet signal processing and artificial intelligence to develop next generation ECG technology. Wavelet signal processing is currently used in many different industries as an important tool to provide insights and new valuable data related to spectral analysis of a signal. HeartSciences’ MyoVista wavECG Cardiac Testing Device is a 12-lead resting electrocardiograph utilizing continuous wavelet transform (CWT) based signal processing. Patented informatics focus on energy related information rather than conventional voltage-based information. HeartSciences mission is to enable accurate, affordable screening for the early detection of heart disease.

In addition to the proprietary informatics, the MyoVista wavECG Device also features the capabilities of a full featured 12-lead resting ECG including analysis using the Glasgow Algorithm, one of the world’s most respected interpretive algorithms. The device has a 15.6-inch high-resolution touchscreen display and incorporates many features commonly associated with a tablet device requiring minimal user training as well as easy and intuitive use. The MyoVista wavECG Device is not currently approved for sale or distribution in the United States and is not currently FDA cleared.

HeartSciences is a privately-held U.S. corporation based in Southlake, Texas.

For more information visit www.heartsciences.com.

Contacts

HeartSciences
Gene Gephart, +1-737-346-1089
gene.gephart@heartsciences.com

 

Investor Contact

Zimmons International Communications

Jennifer K. Zimmons, +1-917-214-3514

jzimmons@zimmonsic.com

 

 

 

HeartSciences Showcases MyoVista® Wavelet ECG at the 2018 International Congress on Electrocardiology (ICE)

SOUTHLAKE, Texas, June 25, 2018 –(BUSINESSWIRE)—HeartSciences, an innovative medical device company, is proud to announce its participation as an exhibitor at the upcoming 2018 International Congress on Electrocardiology (ICE), which will be held in Makuhari Messe, Chiba City, Japan, June 28-30, 2018. ICE2018 will be the joint meeting of the 45th Congress of the International Society of Electrocardiology (ISE) and the 18th Congress of the International Society for Holter and Noninvasive Electrocardiology (ISHNE). This Congress will focus on Electrocardiography, from noninvasive diagnosis to prognosis covering basic electrophysiology, novel signal processing methods of Holter ECG, prognostic ECG techniques for preventing sudden cardiac death, applications of antiarrhythmic agents and direct oral anticoagulants, a critical role of catheter ablation for tachyarrhythmias and appropriate use of implantable devices.

About HeartSciences

HeartSciences is leading innovation in the field of electrocardiography through the application of continuous wavelet transform (CWT) signal processing and artificial intelligence. Wavelet signal processing is currently used in many different industries as an important tool to provide insights and new valuable data related to spectral analysis of a signal. HeartSciences’ MyoVista® Wavelet ECG (wavECG™) is a first-to-market 12-lead resting electrocardiograph with new informatics based on wavelet signal processing. Patented informatics focus on energy related information rather than conventional voltage-based information. HeartSciences mission is to enable accurate, affordable screening for the early detection of heart disease.

In addition to proprietary informatics, the MyoVista wavECG Device has full 12-lead resting ECG capabilities including analysis using the Glasgow Algorithm, one of the world’s most respected interpretive algorithms. The device has a 15.6-inch high-resolution touchscreen display and incorporates many features commonly associated with a tablet device requiring minimal user training with no change in ECG clinical workflow. The MyoVista wavECG Device is not currently FDA approved for commercial sale or distribution in the United States.

HeartSciences is a privately-held U.S. corporation based in Southlake, Texas.

For more information visit www.heartsciences.com.

Contacts

HeartSciences
Gene Gephart, +1-737-346-1089
gene.gephart@heartsciences.com

MedTech Strategist Names HeartSciences as Start-Up to Watch

HEARTSCIENCES:
Artificial Intelligence Improves Frontline Risk Stratification for Heart Diseases

The current screening paradigm for heart disease is missing people at early stages, when diseases are most treatable. HeartSciences has taken a ubiquitous screening tool, the 12-lead ECG, and has, through the application of signal processing and artificial intelligence, turned it into a powerful tool that can detect diastolic dysfunction, an early indicator of most cardiac diseases.

HeartSciences: AI Improves Frontline Risk Sratification for Heart Diseases

 

HeartSciences Announces Professor Peter Macfarlane Joins Clinical Advisory Board

Professor Peter W. Macfarlane, DSc eFESC FRSE, is an expert in the field of electrocardiology and has over 40 years’ experience in the development of computer-based systems for the interpretation of ECGs. He has authored over 300 publications and peer-reviewed papers, as well as numerous books on the subject. Professor Macfarlane is recognized as a pioneer in the use of computers in hospital-based ECG interpretation. The work of his team has been adopted commercially, and the University of Glasgow ECG interpretation analysis developed in his laboratory is currently used worldwide. The Glasgow analysis is incorporated in the MyoVista® wavECG™ Device where it complements HeartSciences by providing computerized analysis of the conventional ECG waveform. At present, he is Emeritus Professor and Honorary Senior Research Fellow of the University of Glasgow. In 2014, Professor Macfarlane was awarded a CBE for services to British healthcare.

 

Peter is the current President of the International Society of Computerized Electrocardiology (ISCE). He also serves as Treasurer of the International Society of Electrocardiology (ISE), having been President in the past. His major interest throughout his career has been the application of computer techniques to ECG interpretation.

 

“HeartSciences’ use of computerized techniques, such as signal processing and artificial intelligence, is truly innovative.  I look forward to contributing to HeartScience’s success,” said Macfarlane.

 

“HeartSciences is honored to have Peter join our Clinical Advisory Board. His wealth of experience and expertise in the application of computer techniques in electrocardiology aligns well with the company’s technology and vision for the future,” said Mark Hilz, chief executive officer of HeartSciences. “We look forward to working with Peter to achieve our shared goals of improving ECG capabilities for the detection of heart disease.”

 

About HeartSciences

HeartSciences is leading innovation in the field of electrocardiology through the application of continuous wavelet transform (CWT) signal processing and artificial intelligence. Wavelet signal processing is currently used in many different industries as an important tool to provide insights and new valuable data related to spectral analysis of a signal. HeartSciences’ MyoVista® Wavelet ECG (wavECG™) Device is a first-to-market 12-lead resting electrocardiograph with new informatics based on wavelet signal processing. Patented informatics focus on energy-related information rather than conventional voltage-based information. HeartSciences’ mission is to enable accurate, affordable screening for the early detection of heart disease.

In addition to proprietary informatics, the MyoVista wavECG Device has full 12-lead resting ECG capabilities including analysis using the Glasgow Algorithm, one of the world’s most respected interpretive algorithms. The device has a 15.6-inch high-resolution touchscreen display and incorporates many features commonly associated with a tablet device, requiring minimal user training with no change in ECG clinical workflow. The MyoVista wavECG Device is not currently available for commercial sale or distribution in the United States.

HeartSciences is a privately-held U.S. corporation based in Southlake, Texas.

For more information visit www.heartsciences.com.

HeartSciences Announces Publication of Clinical Study Results in the Journal of the American College of Cardiology (JACC)

HeartSciences Announces Publication of Clinical Study Results in the Journal of the American College of Cardiology (JACC)

Study demonstrates promising new capabilities for MyoVista® ECG device in detecting Abnormal Cardiac Function

HeartSciences Announces Publication of Clinical Study Results in the Journal of the American College of Cardiology (JACC)