ECG

Largest Ever Real-World Evidence Study of Ambulatory Cardiac Monitoring Demonstrates Clinical Superiority of iRhythm's Zio Long-Term Continuous Monitoring Service

Retrieved on: 
Friday, January 5, 2024
AEM, MAS, Economics, ECG, Probability, Medical Center, Research, ACMS, Master of Science, LTCM, National Association, Health, ACM, Arrhythmia, Northwestern University, Medicare, MCT, American College, Manuscript, Patient, Diagnosis, Medicine, MSCE, AHJ, Medical device

The retrospective study of almost 300,000 patients makes CAMELOT the largest published real-world comparative effectiveness analysis of ambulatory cardiac monitoring.

Key Points: 
  • The retrospective study of almost 300,000 patients makes CAMELOT the largest published real-world comparative effectiveness analysis of ambulatory cardiac monitoring.
  • “Our findings reveal significant variation in selection of monitoring devices, which can be influenced by patient characteristics and other factors.
  • Holter, AEM, MCT, and non-iRhythm LTCM were 50%, 42%, 33%, and 23% less likely to achieve clinical arrhythmia encounter diagnosis compared to the Zio LTCM service, respectively.
  • Non-iRhythm LTCMs were 3.7 times more likely to result in a retest than the Zio LTCM service.

AI-Driven Study Redefines Right Heart Health Assessment With Novel Predictive Model

Retrieved on: 
Thursday, January 4, 2024
Cardiology, UK Biobank, Data-driven, MRI, Survival, American Heart, ECG, American Heart Association, Mount Sinai Health System, Research, DL, Health, Yale School of Medicine, Doctor of Philosophy, Cardiomyopathy, National Institutes of Health, AI, Artificial intelligence, Ventricular septal defect, Lung, MBBS, Bangladesh Technical Education Board, Yale New Haven Hospital, Assistant, MPH, Patient, CTSA, Diagnosis, Intelligence, Journal, Public health, Pulmonary hypertension, Yale school, Medical device

NEW YORK, Jan. 4, 2024 /PRNewswire-PRWeb/ -- Departure from traditional methods marks a significant advance in evaluating heart health, paving the way for more innovative tools and improved patient outcomes

Key Points: 
  • "This novel method could expedite the identification of heart problems, especially in the right ventricle, and potentially lead to earlier and more effective treatment.
  • It holds particular importance for patients with congenital heart disease, who often face issues in the right ventricle."
  • "Our findings mark a significant leap forward in right heart health assessment, offering a glimpse into a future where AI plays a pivotal role in early and accurate diagnosis.
  • This study was supported by the National Heart, Lung, and Blood Institute, National Institutes of Health (R01HL155915), and National Center for Advancing Translational Sciences, National Institutes of Health (CTSA grant UL1TR004419).

Ambient Scientific's Edge AI Processor goes into volume production

Retrieved on: 
Thursday, January 4, 2024
Software development kit, Health, ECG, ISA, Microelectromechanical systems, Instruction set architecture, Business, TSMC, Evaluation, Sensor, Multichannel, AI, Internet, Cloud computing, ADC, Video game

SANTA CLARA, Calif., Jan. 4, 2024 /PRNewswire/ -- Ambient Scientific, The AI Processor Company, announced today that its first AI SoC – GPX10 – designed to run cloud-free AI applications on portable battery-powered devices has gone into volume production. GPX-10 is manufactured at TSMC using 40 nm technology. The product has a complete development platform to enable On-Device/IoT AI Applications, that includes a Software Development Kit with Neural Network Compiler. The Evaluation kit is available for commercial purchase starting Q1 2024.

Key Points: 
  • SANTA CLARA, Calif., Jan. 4, 2024 /PRNewswire/ -- Ambient Scientific, The AI Processor Company, announced today that its first AI SoC – GPX10 – designed to run cloud-free AI applications on portable battery-powered devices has gone into volume production.
  • The product has a complete development platform to enable On-Device/IoT AI Applications, that includes a Software Development Kit with Neural Network Compiler.
  • The team at Ambient Scientific is eager to discover how the industry develops innovative and useful products over time, using its edge AI development platform with GPX-10 AI processor.
  • With its first product getting into volume production for market availability in Q1 2024, Ambient Scientific is executing on its plan to develop newer products to realize its mission of democratizing sustainable AI for the betterment of all human lives.

B-Secur Receives ISO 13485:2016 Certification

Retrieved on: 
Thursday, January 4, 2024
Medical Devices, Health, Health Technology, General Health, Cardiology, Biotechnology, ISO, FDA, Quality management system, Safety, QMS, Cardiovascular disease, ECG, Algorithm, Multimedia, Observation, Certification

B-Secur , a global leader in biosensing algorithms, today announced that it has received ISO 13485:2016, the Quality Management System (QMS) for medical devices.

Key Points: 
  • B-Secur , a global leader in biosensing algorithms, today announced that it has received ISO 13485:2016, the Quality Management System (QMS) for medical devices.
  • View the full release here: https://www.businesswire.com/news/home/20240104585102/en/
    Alan Foreman (R), Chief Executive of B-Secur, pictured with Cameron Moore (L), Quality Manager.
  • Ideal for both medical and non-medical applications, HeartKey® can be implemented to run on device or on the cloud.
  • Cameron Moore, Quality Manager, B-Secur says; “ISO 13845:2016 certification reflects B-Secur’s dedication to quality and further confirms to customers our commitment to continuous improvement, along with the safety and effectiveness of our technology.”

iRhythm Technologies Receives European Union’s CE Marking Under Medical Device Regulation (EU MDR) for its Zio® monitor and ZEUS System

Retrieved on: 
Wednesday, January 3, 2024
BSI, MDR, ECG, Hand, Prevalence, Trial of the century, SAN, CE, Certification, Stroke, Arrhythmia, IRTC, ZEUS, Zio, BSI Group, Notified body, European, Patient, Safety, Medical device

The Zio monitor ECG System secured its CE mark based on compliance to EU MDR standards of performance, quality, safety, and efficacy, along with the body of clinical evidence supporting Zio in detecting potential cardiac arrhythmias.

Key Points: 
  • The Zio monitor ECG System secured its CE mark based on compliance to EU MDR standards of performance, quality, safety, and efficacy, along with the body of clinical evidence supporting Zio in detecting potential cardiac arrhythmias.
  • The new Zio monitor is thinner, lighter, and smaller compared to Zio XT to provide a more inconspicuous wear experience.2-4.
  • Early clinical and patient experience in the United States has shown that Zio monitor has even better wear times and analyzable ECG2.
  • Furthermore, the certification incorporates CE mark for the ZEUS (Zio ECG Utilization Software) System, iRhythm’s advanced deep-learned AI algorithm which supports the capture and analysis of ECG data recorded by Zio monitor.

Sports Data Labs, Inc. Announces Issuance of New U.S. Patent Covering its Novel Generative AI-Based Method for Creating Synthetic Data to Replace Missing and Outlier Data Values

Retrieved on: 
Tuesday, January 2, 2024
Technology, Health Technology, General Sports, Other Science, Artificial Intelligence, Research, Medical Devices, Professional Services, Health, Wearables, Mobile Technology, General Health, Nanotechnology, Science, Other Technology, Software, Hardware, Electronic Design Automation, Sports, Data Management, Patent Law, Consumer Electronics, Other Health, Biometrics, Prior art, ECG, Multimedia, Athlete, Collection, Heart rate, Biomarker, Patent, Sensor, AI, Sport, Insurance, Intelligence, United States patent law, Pharmaceutical industry

11,850,053 to the company covering a novel system and method for calculating accurate, real-time heart rate (HR) measurements from high sampling, electrocardiogram (ECG)-based sensors.

Key Points: 
  • 11,850,053 to the company covering a novel system and method for calculating accurate, real-time heart rate (HR) measurements from high sampling, electrocardiogram (ECG)-based sensors.
  • SD Labs’ issued patent, entitled “A System and Method for Measuring Heart Rate,” also covers a novel method for detecting and replacing missing and outlier sensor-based data values with artificial (i.e., synthetic) data.
  • The issued patent also covers an AI-based method for generating predictive artificial data values for any missing or outlier values within a sensor-based data set, which can be applicable to all types of biological sensor data regardless of sensor type.
  • “Our synthetic data generator enables more complete data sets to be created, a requisite for AI systems to be more effective in analyzing and creating value with data.

PMcardio Launches Certified AI-Powered Solution that Outperforms Doctors in Heart Attack Detection

Retrieved on: 
Thursday, November 23, 2023
Atrium Health, Database, Queen, ECG, Woman, Physician, Medicine, FDA, Hospital, Splenic infarction, Death, Atrium, Chest pain, Patient, Diagnosis, Facial muscles, Christ Hospital, Medical device

This pioneering AI-powered clinical assistant is now the first certified solution proven to outperform doctors in detecting heart attacks.

Key Points: 
  • This pioneering AI-powered clinical assistant is now the first certified solution proven to outperform doctors in detecting heart attacks.
  • Traditional diagnostic methods, focused on the STEMI/NSTEMI criteria, miss about 30% of acute heart attack patients, highlighting the need for more accurate and prompt detection.
  • With over 2,500 hospitals on the waiting list, PMcardio is on track to transform heart attack diagnosis on a global scale.
  • This development is set to have a widespread impact, fundamentally transforming the approach to heart attack diagnosis and treatment around the globe.

HeartSciences Reports Second Quarter Fiscal 2024 Financial Results

Retrieved on: 
Thursday, December 14, 2023
Shift, Science, Global Health, Classification, ECG, FDA, HSCS, Electrocardiography, Patent, American Medical Association, Growth, IPO, Overalls, CPT, Diagnosis, Cardiovascular disease, Intelligence, Algorithm, De novo, Medical device

Southlake, TX, Dec. 14, 2023 (GLOBE NEWSWIRE) -- Heart Test Laboratories, Inc. d/b/a HeartSciences (Nasdaq: HSCS; HSCSW) ("HeartSciences" or the "Company"), an artificial intelligence (AI)-powered medical technology company focused on transforming ECGs/EKGs to save lives through earlier detection of heart disease, today reported financial results for the second quarter fiscal 2024 ended October 31, 2023 and provided a business update.

Key Points: 
  • Southlake, TX, Dec. 14, 2023 (GLOBE NEWSWIRE) -- Heart Test Laboratories, Inc. d/b/a HeartSciences (Nasdaq: HSCS; HSCSW) ("HeartSciences" or the "Company"), an artificial intelligence (AI)-powered medical technology company focused on transforming ECGs/EKGs to save lives through earlier detection of heart disease, today reported financial results for the second quarter fiscal 2024 ended October 31, 2023 and provided a business update.
  • After the fiscal second quarter's close, we successfully completed a series of actions including an equity raise and debt conversion that remedied the Nasdaq shareholders’ equity deficiency.
  • After the close of the second fiscal quarter 2024, the Company raised $9.3 million in net proceeds from sales of common stock and converted $1.1 million of debt to equity.
  • Further, HeartSciences closed a series of license agreements with Mount Sinai which results in Mount Sinai becoming a material shareholder in the Company.

HeartSciences Receives FDA Confirmation for 510(k) Clearance Pathway

Retrieved on: 
Tuesday, December 5, 2023
FDA, Diagnosis, Intelligence, Classification, ECG, Algorithm, De novo, HSCS, Medical device

Southlake, TX, Dec. 05, 2023 (GLOBE NEWSWIRE) -- Heart Test Laboratories, Inc. d/b/a HeartSciences (Nasdaq: HSCS; HSCSW) ("HeartSciences" or the "Company"), an artificial intelligence (AI)-powered medical technology company focused on transforming ECGs/EKGs to save lives through earlier detection of heart disease, today announced that it has received confirmation from the FDA to change the clearance pathway for its MyoVista® wavECG™ device and associated AI-ECG algorithm to a more standard 510(k) submission from the more complex De Novo process.

Key Points: 
  • Southlake, TX, Dec. 05, 2023 (GLOBE NEWSWIRE) -- Heart Test Laboratories, Inc. d/b/a HeartSciences (Nasdaq: HSCS; HSCSW) ("HeartSciences" or the "Company"), an artificial intelligence (AI)-powered medical technology company focused on transforming ECGs/EKGs to save lives through earlier detection of heart disease, today announced that it has received confirmation from the FDA to change the clearance pathway for its MyoVista® wavECG™ device and associated AI-ECG algorithm to a more standard 510(k) submission from the more complex De Novo process.
  • Andrew Simpson, Chief Executive Officer of HeartSciences, said, "The new FDA product classification for AI-ECG paves the way for a more structured and faster 510(k) process for our MyoVista® device, as well as our industry leading library of AI-ECG algorithms.
  • In November, the core lab finished their work on our MyoVista® pivotal study following the conclusion of patient recruitment announced earlier in 2023.
  • We remain on track for submission of the MyoVista® to the FDA in the first half of 2024 and a targeted clearance during 2024.”

HeartSciences Announces Closing of License Agreements with the Icahn School of Medicine at Mount Sinai to Develop and Commercialize AI Cardiovascular Algorithms

Retrieved on: 
Monday, November 20, 2023
Database, Cardiology, ECG, Division, Classification, Mount Sinai Health System, FDA, D3M, Mount Sinai Hospital, HSCS, MD, Doctor of Philosophy, AI, Machine learning, Data science, Assistant, Patient, Diagnosis, Cardiac electrophysiology, Cardiovascular disease, Intelligence, Algorithm, Policy, Medical device

The closing of our licenses with Icahn Mount Sinai now propels us forward with our cardiovascular disease AI-ECG development programs.

Key Points: 
  • The closing of our licenses with Icahn Mount Sinai now propels us forward with our cardiovascular disease AI-ECG development programs.
  • The licenses from Icahn Mount Sinai grant rights to multiple patented and unpatented AI-based ECG/EKG algorithms and technologies for the screening and diagnosis of cardiovascular disease.
  • The AI cardiovascular algorithms are based on technology developed by Icahn Mount Sinai faculty and licensed by Mount Sinai to HeartSciences.
  • The financial interest of Mount Sinai faculty is pursuant to the Mount Sinai Intellectual Property Policy.