FDA

Sanger Heart and Vascular Institute, Atrium Health, treated the first patient with the new implantable medical device following FDA premarket approval
News | Stents
Philips launches Duo Venous Stent System for Treatment of Symptomatic Venous Outflow Obstruction

June 12, 2024 — Royal Philips, a global leader in health technology, announced the first implant of the Duo Venous Stent ...

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Heuron ICH has received FDA 510(k) clearance
News | FDA
Heuron Gets FDA Green Light for Stroke Triage and Notification Solution

June 3, 2024 — Heuron, a specialized medical AI startup focused on brain and neurological disorders based in South Korea ...

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Artificial intelligence (AI)-driven health technology company, Anumana, which developed the FDA-approved ECG-AI LEF algorithm, has announced its receipt of the International Organization for Standardization (ISO) 13485 certification for its Quality Management System.
News | Artificial Intelligence
Cardiac Care AI Company, Anumana, Announces Receipt of ISO 13485 Certification

May 21, 2024 — Anumana, a Cambridge, MA-based artificial intelligence (AI)-driven health technology company and ...

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Cutting-edge tool analyzes data from cardiac remote monitoring devices to assess whether a patient is at high risk of experiencing worsening heart failure, enabling medical teams to intervene and avoid hospitalization.
News | FDA
Implicity Earns FDA Clearance for New Heart Failure Prediction Algorithm

May 17, 2024 —  Implicity, a leader in remote patient monitoring and cardiac data management solutions, announced it has ...

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Abbott recalls HeartMate 3 left ventricular assist system (LVAS) implant kit for risk of blood leakage or air entering system between inflow cannula and apical cuff
News | FDA
FDA Announces Abbott Recall of HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kit

May 15, 2024 — The U.S. Food and Drug Administration (FDA) announced that Abbott is recalling the HeartMate 3 LVAS by ...

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The US Food and Drug Administration is alerting health care providers and facilities about our continued safety and quality concerns with the following Getinge/Maquet cardiovascular medical devices
News | FDA
FDA Notes Safety and Quality Concerns with Getinge/Maquet Cardiovascular Devices

May 8, 2024 —  The US Food and Drug Administration (FDA) is alerting health care providers and facilities about our ...

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News | FDA
4C Medical's AltaValve System Secures Dual FDA Breakthrough Device Designations, Expediting Patient Access to Advanced Mitral Valve Therapies

May 8, 2024 — 4C Medical Technologies, Inc. ("4C Medical"), a medical device company dedicated to advancing minimally ...

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AngioFlow by RapidAI will facilitate confident clinical decision-making immediately prior to or after neuro-interventional procedures
News | FDA
RapidAI Secures FDA Clearance for Perfusion Imaging in the Angiography Suite

May 7, 2024 — RapidAI, the global leader in developing clinically deep Artificial Intelligence (AI) and technology ...

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A look at DAIC's top-viewed content for April 2024
Feature | Cardiovascular Business | By Melinda Taschetta-Millane
DAIC's Top 10 for April

Clinical trials and innovative technology took center stage during the month of April, racking up some record number ...

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Groundbreaking technology for the precise, automatic measurement of peripheral blood vessels to optimize treatment strategies
News | FDA
Provisio Medical Announces FDA Clearance of the Provisio SLT IVUS System

April 25, 2024 — Provisio Medical announced FDA 510(k) clearance of the Provisio SLT IVUS System. Sonic Lumen Tomography ...

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First FDA approved transcatheter therapy for patients with tricuspid regurgitation
News | Structural Heart
Atlantic Health System’s Morristown Medical Center Treats First Patient in New Jersey with Edwards’ EVOQUE Tricuspid Valve Replacement

April 25, 2024 — Atlantic Health System’s Morristown Medical Center treated the first patient in New Jersey using Edward ...

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Patent covers use of AI-ECG for any echo measure of diastolic function, which is crucial for heart screening and early detection of heart disease
News | FDA
Innovative Aspiration Thrombectomy System by Expanse ICE Receives FDA Clearance for Vessels of the Peripheral Arterial and Venous Systems

April 24, 2024 — Expanse ICE announced today the ICE Aspiration System has received 510(k) clearance from the U.S. Food ...

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RCE Technologies, Inc. (RCE) is an innovative artificial intelligence (AI) based medical technology company dedicated to early heart attack detection.
News | FDA
RCE Technologies, Inc. Announces First-In-Human Transdermal Continuous Cardiac Biomarker Monitoring

April 22, 2024 — At the annual American College of Cardiology conference (ACC.24) in Atlanta last week, RCE Technologies ...

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AB-1002 is being studied for the treatment of adults with non-ischemic cardiomyopathy and New York Heart Association (NYHA) Class III heart failure symptoms
News | FDA
AskBio Receives FDA Fast Track Designation for AB-1002 Investigational Gene Therapy Program in Congestive Heart Failure

April 18, 2024 — Bayer AG and Asklepios BioPharmaceutical, Inc., a gene therapy company wholly owned and independently ...

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Abbott/Thoratec Corp. is recalling HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS) due to an issue called Extrinsic Outflow Graft Obstruction, (EOGO).
News | FDA
FDA Announces Recalls of Abbott/Thoratec Corp. Heartmate II and Heartmate 3 Left Ventricular Assist System (LVAS) Due to Long-term Buildup of biological material Causing an Obstruction

April 15, 2024 —  The U.S. Food and Drug Administration (FDA) announced Abbott/Thoratec Corp. is recalling HeartMate II ...

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