FDA

The U.S. Food and Drug Administration (FDA) is providing an update to the February 27, 2023 Letter to Health Care Providers about the potential risk of early structural valve deterioration (SVD) with Abbott Trifecta valves, including the Trifecta Valve and Trifecta Valve with Glide Technology (GT)
News | Heart Valve Technology
FDA Issues Update on Abbott Trifecta Valves: Potential Risk of Early Structural Valve Deterioration

July 31, 2023 — Today, the U.S. Food and Drug Administration (FDA) is providing an update to the February 27, 2023 ...

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AI demonstrated high accuracy, reduced non-diagnostic outputs, and identified HFpEF patients with worse outcomes.
News | Cardiovascular Clinical Studies
Study Confirms Ultromics' AI Can Improve HFpEF Detection Using a Single Echocardiogram View

July 31, 2023 — Applying AI to a single apical four chamber (A4C) view echocardiogram provides accurate information to ...

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GE HealthCare is recalling malfunctioning TruSignal sensors that may reduce the amount of energy sent to the heart during defibrillation without any notification to the care provider
News | Defibrillator Monitors
GE HealthCare Recalls TruSignal SpO2 Sensors for Issues That May Reduce Defibrillation Energy, Expose Patients to Unintended Voltage, or Give Inaccurate Readings

July 28, 2023 — GE HealthCare is recalling malfunctioning TruSignal sensors that may reduce the amount of energy sent to ...

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Primary endpoints across three studies underscore the importance of accuracy, utility, and efficiency in coronary artery disease diagnostics and clinical decision making
News | Cardiovascular Clinical Studies
HeartFlow to Announce New Data at SCCT23

July 28, 2023 — Respective results from the REVEALPLAQUE, DECODE, and SMART-CT clinical studies demonstrate the accuracy ...

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Device manufacturers will be displaying their latest technologies at the 2023 Society of Cardiovascular Computed Tomography Annual Scientific Meeting (SCCT2023) being held in Boston from July 27 - 30.
Feature | SCCT
Innovations in Photon Counting CT, AI to be Showcased at SCCT2023

Device manufacturers will be displaying their latest technologies at the 2023 Society of Cardiovascular Computed ...

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New AI guidance software will allow more medical professionals to conduct cardiac ultrasound in multiple care settings expanding patient access to cardiac imaging
News | Cardiovascular Ultrasound
FDA Grants Clearance for UltraSight’s AI-Powered Cardiac Ultrasound Technology

July 27, 2023 —UltraSight, a digital health pioneer transforming cardiac imaging through the power of artificial ...

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Abiomed is recalling the Impella Intravascular Left Sided Blood Pumps because the pump’s Instructions for Use (IFU) do not adequately address precautions to take when treating patients who have undergone transcatheter aortic valve replacement (TAVR)
News | Stents
Abiomed Recalls All Impella Left Sided Blood Pumps for Risk of Motor Damage After Contact with Transcatheter Aortic Valve Replacement (TAVR) Stent

July 27, 2023 — Abiomed is recalling the Impella Intravascular Left Sided Blood Pumps because the pump’s Instructions ...

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Abiomed is recalling the Impella Intravascular Left Sided Blood Pumps because the pump’s Instructions for Use (IFU) do not adequately address precautions to take when treating patients who have undergone transcatheter aortic valve replacement (TAVR)
News | ECG
MyoVista wavECG goes into clinical use at the Naya Imaging Center in Denmark

July 27, 2023 — Heart Test Laboratories, Inc. d/b/a HeartSciences, an artificial intelligence (AI)-based medical ...

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Abbott is recalling the Amplatzer Steerable Delivery Sheath due to an increased risk for air emboli to be introduced into patients who have procedures with this device.
News | Left Atrial Appendage (LAA) Occluders
Abbott Recalls Amplatzer Steerable Delivery Sheath for Increased Risk of Air Embolism

July 26, 2023 — Abbott is recalling the Amplatzer Steerable Delivery Sheath due to an increased risk for air emboli to ...

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