FDA

Latest innovation has the potential to reduce anesthesia during minimally invasive procedures
News | Transesophageal Echo (TEE)
New Philips Mini TEE Ultrasound Transducer Helps Improve Cardiac Care for More Patients

January 31, 2024 — Royal Philips, a global leader in health technology, announced that its latest TEE transducer ...

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With improvements to the stent graft delivery system enabling a 1 Fr profile reduction on the majority of sizes, the device now offers the most 6 Fr compatible configurations among balloon expandable stent grafts
News | FDA
W. L. Gore Receives FDA Approval for Lower Profile Gore Viabahn VBX Balloon Expandable Endoprosthesis

January 31, 2024 — As part of efforts to continuously improve medical solutions for patients with complex vascular ...

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The U.S. Food and Drug Administration (FDA), has granted approval to Boston Scientific for its FARAPULSE Pulsed Field Ablation System.
News | FDA
Boston Scientific Receives FDA Approval for FARAPULSE Pulsed Field Ablation System

January 31, 2024 — Boston Scientific Corporation announced it has received U.S. Food and Drug Administration (FDA) appro ...

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A public-private partnership Think Tank
News | Cardiovascular Education
Cardiac Safety Research Consortium Announces Think Tank Program with FDA Regulators, Industry and Academia Focused on Cardiac Remote Monitoring Trials and AI

January 15, 2024 — A public-private partnership Think Tank, scheduled for Feb. 29-March 1, will be presented by the Card ...

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FDA cleared, evidence-based AI and machine learning-based algorithm detects heart disease-associated ischemia
News | Artificial Intelligence
Cleerly Launches Cleerly ISCHEMIA Solution for Heart Disease Analysis

January 9, 2024 — Cleerly, the company working to create a new standard of care for the diagnosis of heart disease ...

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Diagnostic and Interventional Cardiology
Feature | Cardiovascular Business | By Melinda Taschetta-Millane
2023 in Review: A Look at the Year's Top 10 Topics

As the Diagnostic and Interventional Cardiology (DAIC) team welcomes in the New Year, we also have taken a few moments ...

Home January 05, 2024
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Embedded AI and user assistance features of the Siemens Healthineers Somatom, which has received FDA clearance, deliver workflow efficiencies, according to a company statement.
News | Computed Tomography (CT)
Siemens Healthineers Announces FDA Clearance of Somatom Pro.Pulse Dual-Source CT Scanner

December 19, 2023 — Siemens Healthineers announced the Food and Drug Administration (FDA) clearance of the Somatom Pro ...

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News | Cardiovascular Clinical Studies
Clinical Trial Results from Peerbridge Health Unveil Direct-from-ECG Sleep Apnea Detection Using COR Wearable Platform

December 19, 2023 — Peerbridge Health has announce the successful completion and findings of its prospective ...

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Medtronic plc, a global leader in healthcare technology, today announced that the United States Food and Drug Administration (FDA) has approved the PulseSelect Pulsed Field Ablation (PFA) System for the treatment of both paroxysmal and persistent atrial fibrillation (AF).
News | Atrial Fibrillation
Medtronic Creates History with FDA Approval of its Novel PulseSelect Pulsed Field Ablation System to Treat Atrial Fibrillation

December 14, 2023 — Medtronic plc, a global leader in healthcare technology, today announced that the United States Food ...

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The U.S. Food and Drug Administration (FDA) announced Cordis US Corp is recalling its INFINITI Angiographic Catheter due to products being shipped without undergoing sterilization procedures
News | Angiographic Catheter
Cordis US Corp Recalls INFINITI Angiographic Catheter due to Products Being Shipped Without Undergoing Sterilization Procedures

December 7, 2023 — The U.S. Food and Drug Administration (FDA) announced Cordis US Corp is recalling its INFINITI ...

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Take a look at the news making top headlines during the month of November on dicardiology.com
Feature | Cardiovascular Business | By Melinda Taschetta-Millane
DAIC's Top 10 for November

November was a busy month with many FDA approvals and breaking clinical trial results. Take a look at the news making ...

Home December 05, 2023
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The device would be the first clinical-grade, diagnostic wrist-worn device for long term Afib monitoring
News | Wearables
Clinical Smartwatch Finds Success at Identifying Atrial Fibrillation

December 1, 2023 — As the use of wearable technology grows, smartwatches are marketed across the globe to consumers as a ...

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First Phase 3 study of TNX-103 in PH-HFpEF patients to start in 4Q 2023 (The LEVEL Study)
News | FDA
Tenax Therapeutics Announces FDA Clearance of IND for TNX-103 (oral levosimendan) for the Treatment of Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF), Initiation of Phase 3 sites expected 2023

November 27, 2023 — Tenax Therapeutics, Inc., a specialty pharmaceutical company focused on identifying, developing and ...

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News | Atrial Fibrillation
Positive Results from ReVeRA Phase 2 Study of Etripamil Nasal Spray in AFib-RVR Presented by Milestone Pharmaceuticals during AHA 2023

November 24, 2023 — During the American Heart Association Scientific Sessions 2023, held recently in Philadephia, PA, Mi ...

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News | Pharmaceuticals
BridgeBio Pharma Presents Additional Clinical Outcomes Data from the Phase 3 ATTRibute-CM Study of Acoramidis in Patients with Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)

November 21, 2023 — BridgeBio Pharma, Inc., a commercial-stage biopharmaceutical company focused on genetic diseases and ...

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