Cardiac electrophysiology

Orchestra BioMed Granted FDA Approval of IDE to Initiate BACKBEAT Pivotal Study of BackBeat CNT™ for the Treatment of Hypertension in Pacemaker Patients

Retrieved on: 
Tuesday, September 19, 2023
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Orchestra BioMed and Medtronic plc (NYSE: MDT) formed a strategic collaboration for the development and commercialization of AVIM therapy for hypertensive pacemaker patients in July 2022.

Key Points: 
  • Orchestra BioMed and Medtronic plc (NYSE: MDT) formed a strategic collaboration for the development and commercialization of AVIM therapy for hypertensive pacemaker patients in July 2022.
  • Under the collaboration, Medtronic is providing Orchestra BioMed with development, clinical, and regulatory support for the BACKBEAT global pivotal study, which Orchestra BioMed is sponsoring.
  • Orchestra BioMed will share in the revenues generated from Medtronic sales of the AVIM-enabled pacing systems.
  • “We are thrilled to receive IDE approval from the FDA and move forward with plans to initiate the BACKBEAT global pivotal study, which is designed to support potential future regulatory review and potential approval of AVIM therapy for hypertensive patients indicated for a pacemaker.

Cardiovascular Organizations Pursue New, Independent Medical Board

Retrieved on: 
Thursday, September 21, 2023
CME, Learning, ACC, Cardiac electrophysiology, Society, FHRS, Internal medicine, HRS, American Heart Association, American Board of Medical Specialties, ABMS, SCAI, American Board of Internal Medicine, FACC, Cardiology, Continuing medical education, Doctor of Philosophy, AHA, Certification, Organization, Medical specialty, American Board of Commissioners for Foreign Missions, New Board, Patient, Physician, Heart Failure Society of America, Knowledge, American College, Maintenance of Certification, Maintenance, Nursing, MD

WASHINGTON, Sept. 21, 2023 /PRNewswire/ -- Many of the nation's most prominent cardiovascular organizations, representing tens of thousands of physicians, unite today to pursue the creation of a new Board for cardiovascular medicine. The proposed new Board would be independent of the American Board of Internal Medicine, where the cardiology certification process currently exists. Collectively, the American College of Cardiology (ACC), Heart Failure Society of America (HFSA), Heart Rhythm Society (HRS) and Society for Cardiovascular Angiography & Interventions (SCAI) are working together to submit a new Board application, with potential for additional consortium members to join.

Key Points: 
  • WASHINGTON, Sept. 21, 2023 /PRNewswire/ -- Many of the nation's most prominent cardiovascular organizations, representing tens of thousands of physicians, unite today to pursue the creation of a new Board for cardiovascular medicine.
  • The proposed new Board would be independent of the American Board of Internal Medicine, where the cardiology certification process currently exists.
  • "We know that the cardiovascular community is ready for an independent, self-governed entity, and we are proud to develop this new Board with cardiologists and cardiology organizations at the helm."
  • Together, the consortium will submit an application to the American Board of Medical Specialties (ABMS), requesting an independent medical Board for cardiovascular medicine to pursue a new competency-based approach to continuous certification—one that harnesses the knowledge, skills and attitudes required to sustain professional excellence and care for cardiovascular patients effectively.

Attune Medical’s ensoETM™ Granted FDA De Novo Marketing Authorization to Reduce the Likelihood of Ablation-related Esophageal Injury Resulting from Radiofrequency Cardiac Ablation Procedures

Retrieved on: 
Thursday, September 14, 2023
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Attune Medical has been granted De Novo marketing authorization from the US Food and Drug Administration (FDA) for its ensoETM device to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures.

Key Points: 
  • Attune Medical has been granted De Novo marketing authorization from the US Food and Drug Administration (FDA) for its ensoETM device to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures.
  • View the full release here: https://www.businesswire.com/news/home/20230914650329/en/
    Attune Medical has been granted De Novo marketing authorization from the US Food and Drug Administration (FDA) for its ensoETM device to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures.
  • It is the most common type of cardiac ablation procedure, with over 300,000 per year performed in the US alone.
  • This De Novo marketing authorization expands the ensoETM’s indications for use to reduce the likelihood of esophageal injury resulting from radiofrequency cardiac ablation procedures.

RhythmScience Announces Formation of Medical Advisory Board

Retrieved on: 
Thursday, August 31, 2023
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SAN FRANCISCO, Aug. 31, 2023 /PRNewswire/ -- RhythmScience, a leader in cardiac data management and services, today announced the formation of its Medical Advisory Board (MAB).

Key Points: 
  • SAN FRANCISCO, Aug. 31, 2023 /PRNewswire/ -- RhythmScience, a leader in cardiac data management and services, today announced the formation of its Medical Advisory Board (MAB).
  • "We selected MAB members across a range of cardiology expertise, and we are excited to work with this esteemed group."
  • said Shawn Kumar, CEO of RhythmScience.
  • With their collective knowledge and expertise, we are confident in our ability to positively impact the future of cardiac care."

MEDICARDIA HEALTH INC. INCORPORATES WEARABLE ECG INTO ADVANCED REMOTE PATIENT MONITORING PLATFORM FOR ATRIAL FIBRILLATION SCREENING

Retrieved on: 
Wednesday, August 23, 2023
Stroke, Atrial fibrillation, Cardiovascular disease, Cardiac electrophysiology, MD, Patient, Risk, AF, FDA, Medical device, Pharmaceutical industry

MILWAUKEE, Aug. 23, 2023 /PRNewswire/ -- MediCardia Health announced the integration of wearable ECG from FDA registered consumer devices for use in remote monitoring of patients with and at risk for developing atrial fibrillation (AF).

Key Points: 
  • MILWAUKEE, Aug. 23, 2023 /PRNewswire/ -- MediCardia Health announced the integration of wearable ECG from FDA registered consumer devices for use in remote monitoring of patients with and at risk for developing atrial fibrillation (AF).
  • The advance marks an important milestone for the company in streamlining care of people with atrial fibrillation through remote monitoring and virtual care.
  • "Atrial fibrillation is the most common heart rhythm disorder, affecting more than 40 million people around the world.
  • Atrial fibrillation increases the risk of stroke five-fold and these strokes are often fatal or disabling, particularly because 25-40% of patients are not even aware they are in AF.

The Inner Circle Acknowledges, Stephen L. Moore as a Pinnacle Platinum Healthcare Professional for his contributions to the field of Osteopathic Medicine

Retrieved on: 
Monday, August 21, 2023
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AVON LAKE, Ohio, Aug. 21, 2023 /PRNewswire/ -- Prominently featured in The Inner Circle, Stephen L. Moore is acknowledged as a Pinnacle Platinum Healthcare Professional for his contributions to the field of Osteopathic Medicine.

Key Points: 
  • AVON LAKE, Ohio, Aug. 21, 2023 /PRNewswire/ -- Prominently featured in The Inner Circle, Stephen L. Moore is acknowledged as a Pinnacle Platinum Healthcare Professional for his contributions to the field of Osteopathic Medicine.
  • Dr. Moore pursued higher education at the University of Mississippi where he earned a Bachelor's Degree.
  • He then attended Kansas City University of Medicine and Biosciences College of Osteopathic Medicine where he received a Doctor of Osteopathic Medicine degree.
  • Aside from his professional pursuits, Dr. Moore enjoys spending time with his family, cooking, and travel.

Heart & Rhythm Institute of Trinity and Avertix Announce Partnership to Improve Cardiac Care and Patient Monitoring

Retrieved on: 
Wednesday, August 16, 2023
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EATONTOWN, N.J. and TRINITY, Fla., Aug. 16, 2023 (GLOBE NEWSWIRE) -- Avertix Medical, Inc. (“Avertix” or the “Company”), a company focused on improving long-term management and outcomes of high-risk coronary disease in patients who have survived one or more heart attacks, and the Heart & Rhythm Institute of Trinity, an ambulatory surgery center created by ten of the top cardiologists in the Tampa Bay area, announced today they have entered into an agreement to make the Guardian™ System, the first and only FDA-approved implantable heart attack detection and warning system, available to the Heart & Rhythm Institute of Trinity and its collaborative group of cardiologists who work across seven cardiology practices and serve seven hospitals in the area. This partnership seeks to enhance the Heart & Rhythm Institute’s commitment to redefining the future of cardiac care with cutting-edge technology.

Key Points: 
  • This partnership seeks to enhance the Heart & Rhythm Institute’s commitment to redefining the future of cardiac care with cutting-edge technology.
  • Avertix’s Guardian System is designed to detect acute coronary syndrome events, such as heart attacks—even silent and atypical symptomatic heart attacks—in real time.
  • The implantable device is designed to continuously capture cardiac signals from inside the heart in order to provide life-saving alerts to patients and healthcare professionals, enabling seamless and personalized cardiac care.
  • “For many cardiac patients, the risk of subsequent heart attacks brings a sense of fear to their lives.

CathVision Secures FDA Clearance of First & Only EP Recording System with AI Algorithm to Measure Success of Cardiac Ablation

Retrieved on: 
Tuesday, August 15, 2023
Alvin Benjamin Rubin, Cardiac electrophysiology, Noise, PVI, Atrial fibrillation, NYU, Algorithm, Fidelity Investments, ECG, Department of Medicine – University of Pamplona, Arrhythmia, Signal, Acquisition, Death-inducing signaling complex, Patient, Physician, Electrophysiology, Cardiology, EP, NYU Langone Health, Diagnosis, AF, FDA, Medical device, Medical imaging, Medicine

COPENHAGEN, Denmark, Aug. 15, 2023 /PRNewswire/ -- CathVision, a medical technology company developing innovative electrophysiology solutions designed to enhance clinical decision making in the EP lab, today announced the FDA clearance and commercial availability of the PVI AnalyzerTM and Signal ComplexityTM algorithms. These algorithms are part of the CARDIALYTICSTM suite of artificial intelligence-powered analytics integrated into the ECGenius System.1 

Key Points: 
  • The CARDIALYTICS suite includes:
    PVI Analyzer: a signal-based AI algorithm capable of confirming PVI isolation status across multiple cardiac ablation modalities when physicians treat complex arrhythmias such as atrial fibrillation.
  • Signal Complexity: an algorithm to help physicians visualize and quantify atrial fibrillation (AF) complexity parameters in patients with persistent AF.
  • ECGenius System is now the only EP recording system with an AI algorithm to facilitate electrogram interpretation.
  • With exceptional data from the ECGenius System, intelligent automated analyses can effectively enable physicians to confirm the success of ablation efforts.

atai Life Sciences Reports Second Quarter 2023 Financial Results and Operational Highlights, and Announces Clinical Data from the Phase 1 Study of DMX-1002 (Ibogaine)

Retrieved on: 
Thursday, August 10, 2023
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“Looking ahead to the second half of 2023 and beyond, we believe we are well positioned to continue advancing our key clinical programs.

Key Points: 
  • “Looking ahead to the second half of 2023 and beyond, we believe we are well positioned to continue advancing our key clinical programs.
  • Drug-induced prolongation of the QT interval is a phenomenon that has been, with many but not all drugs, associated with cardiac arrhythmias.
  • The single-blinded Phase 1 study assessed the safety, tolerability and pharmacokinetics of single-ascending doses of DMX-1002 in healthy volunteers.
  • Enrollment has been recently completed and the company expects to report initial clinical data in Q4 2023.

Masimo Announces FDA 510(k) Clearance of Radius VSM™

Retrieved on: 
Monday, June 5, 2023
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Masimo (NASDAQ: MASI) today announced that Radius VSM™ , a patient-worn, continuous multi-parameter vital signs monitor, has received FDA 510(k) clearance.

Key Points: 
  • Masimo (NASDAQ: MASI) today announced that Radius VSM™ , a patient-worn, continuous multi-parameter vital signs monitor, has received FDA 510(k) clearance.
  • Designed on a modular platform, Radius VSM allows clinicians to monitor a wide variety of physiological measurements, including Masimo SET® pulse oximetry , noninvasive blood pressure, temperature, respiration rate, and electrocardiography (ECG).
  • By combining the reliability and accuracy of larger bedside monitors with the comfort and freedom of a wearable device, Radius VSM allows ambulation and movement while ensuring patients remain continuously monitored.
  • From a technical perspective, we had no doubt about the reliability of the solution as we have been working with Masimo for many years now.