Industry Press Releases

Jun 2, 2021 | Industry Press Releases
Siemens Healthineers Receives CE Mark for the ACUSON AcuNav Volume ICE Catheter

Siemens Healthineers has announced that it has received CE Mark for the AcuNav Volume ICE (intracardiac echocardiography) catheter, an imaging guide that provides real-time, wide-angle visualization of heart anatomy during structural heart and electrophysiology procedures.

Apr 13, 2021 | Industry Press Releases
Acutus Medical Announces FDA Clearance of AcQCross™, a Full Suite of Universal Transseptal Crossing Devices

CARLSBAD, Calif., April 13, 2021 (GLOBE NEWSWIRE) — Acutus Medical, Inc. (“Acutus”) (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced the FDA clearance of the AcQCross™ family of universal transseptal crossing devices.

Apr 8, 2021 | Industry Press Releases
Abbott Receives CE Mark Approval For Next-generation Triclip™ Device, Offering New Innovations For Tricuspid Heart Valve Repair

Abbott (NYSE: ABT) today announced it has received CE Mark for its next-generation TriClip™ Transcatheter Tricuspid Valve Repair System, the first-of-its-kind minimally invasive tricuspid heart valve repair device available in Europe to treat tricuspid regurgitation (TR).

Mar 31, 2021 | Industry Press Releases
FDA Clears EnsiteVascular Femoral Compression Device

OLATHE, KANSAS, Mar. 31, 2020 – EnsiteVascular™ announced that its SiteSeal™ Femoral Compression Device received market approval by the Food and Drug Administration (FDA) as a vascular closure device (VCD). SiteSeal™ is a next-generation VCD that simulates manual compression while significantly reducing patient and user variability and unnecessary complications.

Jan 29, 2021 | Industry Press Releases
Medtronic Receives FDA Approval of DiamondTemp Ablation System for the Treatment of Patients with Atrial Fibrillation

Medtronic plc (NYSE:MDT), announced it has received U.S. Food and Drug Administration (FDA) approval of the DiamondTemp™ Ablation (DTA) system which treats patients with recurrent, symptomatic paroxysmal atrial fibrillation (AF) and who have been unresponsive to drug therapy. The DiamondTemp system is the first FDA-approved, temperature-controlled, irrigated radiofrequency (RF) ablation system with diamonds currently available […]

Jan 27, 2021 | Industry Press Releases
Occlutech’s Atrial Flow Regulator (AFR) Receives U.S. FDA Breakthrough Device Designation for Heart Failure (HF)

The U.S. Food and Drug Administration (FDA) has granted Occlutech a Breakthrough Device designation for its first-in-class, implantable Atrial Flow Regulator (AFR) for heart failure (HF) patients with preserved (HFpEF) or reduced (HFrEF) ejection fraction.

Jan 26, 2021 | Industry Press Releases
Aktiia® Receives CE Mark Approval for Breakthrough 24-7 Blood Pressure Monitoring System

Aktiia today announced the first 24-7, automated blood pressure monitoring system that easily and comfortably gathers data during the day and while sleeping. This groundbreaking medical innovation will now provide people and their physicians comprehensive insights into blood pressure patterns that will better inform the diagnosis and management of hypertension.

Jan 19, 2021 | Industry Press Releases
InCarda Therapeutics Announces Enrollment of First U.S. Patient in Phase 2 INSTANT Trial of InRhythm™ for Treatment of Atrial Fibrillation

InCarda Therapeutics, Inc. (“InCarda”), a privately-held biopharmaceutical company developing first-of-their-kind inhaled therapies for cardiovascular diseases, announced dosing of the first U.S. patient in the company’s multinational INSTANT Phase 2 clinical trial of InRhythm™ (flecainide for inhalation) in patients with recent-onset paroxysmal atrial fibrillation (PAF).

Dec 21, 2020 | Industry Press Releases
First Patients, Including a COVID-19 Patient, Treated with Abiomed’s Innovative ECMO Technology

Abiomed (NASDAQ: ABMD) announces the first two patients in the world have been treated with the Abiomed Breethe OXY-1 System, a compact cardiopulmonary bypass system. The advanced ECMO technology pumps, oxygenates, and removes carbon dioxide from the blood for patients whose lungs can no longer provide sufficient end-organ oxygenation.

Dec 21, 2020 | Industry Press Releases
Edwards Treats First Patient In U.S. Clinical Trial Evaluating Minimally Invasive Device For Mitral Valve Disease

IRVINE, Calif., Dec. 21, 2020 — Edwards Lifesciences (NYSE: EW), today announced that the first patient has been treated in the RESTORE clinical trial, which will evaluate the safety and effectiveness of the investigational HARPOON Beating Heart Mitral Valve Repair System in the United States and Canada.

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