FDA

The 510(k) application covers Evie Ring’s pulse oximeter that includes heart rate and SpO2 data, and is expected to make it one of the first consumer wearables that is also cleared for clinical use

News | Wearables

Movano Health Achieves Major Milestone with First FDA Filing for Evie Ring’s Pulse Oximeter

August 7, 2023 — Movano Health, a purpose-driven healthcare solutions company at the intersection of medical and ...

August 07, 2023

News | Wearables

Biosense Webster Receives FDA Approval for Multiple Atrial Fibrillation Ablation Products to be Used in a Workflow Without Fluoroscopy

August 7, 2023 — Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson M ...

August 07, 2023

Merit’s WAVE study is a prospective, randomized, controlled, multicenter study

News | Cardiovascular Clinical Studies

Merit Medical’s WRAPSODY Arteriovenous Access Efficacy (WAVE) Pivotal Study Completes Enrollment

August 3, 2023 — Merit Medical Systems, a leading global manufacturer and marketer of healthcare technology, today ...

August 03, 2023

the U.S Food and Drug Administration (FDA) has cleared the QuikClot Control+ Hemostatic Device to include mild and moderate bleeding in cardiac surgical procedures and bone surface bleeding following a sternotomy

News | Cath Lab

Teleflex Receives FDA Clearance for Expanded Indication for QuikClot Control+ Hemostatic Device Usage in Cardiac Surgical Procedures

August 2, 2023 — Teleflex Incorporated, a leading global provider of medical technologies, announced the U.S Food and ...

August 02, 2023

LX2020 preclinical studies demonstrated proof-of-concept with treatment restoring desmosomal integrity, reducing arrhythmias, and extending survival in a clinically relevant murine model

News | Pharmaceuticals

LEXEO Therapeutics Announces FDA Clearance of IND for LX2020, an AAV-based Gene Therapy Candidate for PKP2 Arrhythmogenic Cardiomyopathy

August 1, 2023 —LEXEO Therapeutics, a clinical-stage gene therapy company advancing adeno-associated virus (AAV)-based ...

August 01, 2023

Here is a look at what DAIC viewers were reading during the month of July

Feature | Cardiovascular Business | By Melinda Taschetta-Millane

What Viewers Were Reading in July

Here is a look at what DAIC viewers were reading during the month of July:

1. Lessons Learned from World’s First ...

August 01, 2023

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 ...

July 31, 2023

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 ...

July 31, 2023

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 ...

July 28, 2023

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 ...

July 28, 2023

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 ...

July 28, 2023

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 ...

July 27, 2023

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 ...

July 27, 2023

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 ...

July 27, 2023

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 ...

July 26, 2023