Industry Press Releases

Dec 17, 2020 | Industry Press Releases
FDA Approves Labeling Update for Abbot’s HeartMate 3 Heart Pump for use in Pediatric Patients

Abbott (NYSE: ABT) today announced the U.S. Food and Drug Administration (FDA) has approved updated labeling for the company’s HeartMate 3™ heart pump to be used in pediatric patients with advanced refractory left ventricular heart failure. With the updated labeling, physicians now have additional options for treating this underserved population awaiting a heart transplant or […]

Dec 15, 2020 | Industry Press Releases
ACIST Medical Systems Announces Distribution Partnership with Medis Medical Imaging

EDEN PRAIRIE, MINN. (December 15, 2020) – ACIST Medical Systems, Inc., a Bracco Group Company, today announced a formal distribution partnership with Medis Medical Imaging to co-market in North America. This partnership is focused on Quantitative Flow Ratio (QFR®), a novel, non-invasive angiography based physiologic assessment of the presence and extent of coronary artery disease.

Dec 9, 2020 | Industry Press Releases
SoniVie Receives FDA Breakthrough Device Designation for the TIVUS System for Renal Artery Denervation

Tel Aviv, Israel – December 9, 2020 – SoniVie, an Israeli company developing a novel proprietary Therapeutic Intra-Vascular Ultrasound (TIVUS) System to treat a variety of hypertensive disorders, today announced that it has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the TIVUS System for renal artery denervation for […]

Oct 26, 2020 | Industry Press Releases
FDA Grants 510(k) Clearance for Abiomed’s Innovative Cardiopulmonary Support Technology

DANVERS, Mass.–(BUSINESS WIRE)–The United States Food and Drug Administration (FDA) has granted Abiomed (NASDAQ: ABMD) a 510(k) clearance for an all-in-one, compact cardiopulmonary bypass system called the Abiomed Breethe OXY-1 System™.

Sep 16, 2020 | Industry Press Releases
Medtronic TYRX™ Absorbable Antibacterial Envelope Is Cost Effective for Patients at Increased Risk of Infections

DUBLIN, Sept. 16, 2020 /PRNewswire/ — Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced new data from the landmark WRAP-IT study, showing the TYRX™ Absorbable Antibacterial Envelope (TYRX Envelope) is cost-effective for patients at increased risk of infections who receive cardiac implantable electronic devices (CIEDs).

Sep 11, 2020 | Industry Press Releases
Avinger Receives FDA Clearance of Ocelaris Next Generation Image-guided CTO Crossing System

Avinger, Inc. (NASDAQ: AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of patients with Peripheral Artery Disease (PAD), announced that the Company received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its Ocelaris next-generation image-guided chronic total occlusion (CTO) crossing system.

Sep 9, 2020 | Industry Press Releases
Medtronic Receives Breakthrough Device Designation from FDA, Begins Early Feasibility Study for Investigational Intrepid™ Transcatheter Valve System for the Treatment of Tricuspid Valve Regurgitation

Medtronic announced the U.S. Food and Drug Administration’s (FDA) approval of an early feasibility study (EFS) of the Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) system in patients with severe, symptomatic tricuspid regurgitation, a disease in which the diseased, damaged or malfunctioning tricuspid valve allows blood to flow back into the heart’s upper right chamber causing […]

Aug 4, 2020 | Industry Press Releases
Abbott Announces Start of Study to Evaluate New Device to Treat Recurrent Atrial Fibrillation

ABBOTT PARK, Ill., Aug. 4, 2020 /PRNewswire/ — Abbott (NYSE: ABT) announced first enrollments in the TactiFlex PAF IDE study to evaluate a new device to treat people suffering from paroxysmal atrial fibrillation (PAF), a type of irregular heartbeat. The study will evaluate the performance of the investigational TactiFlex™ Ablation Catheter, Sensor Enabled™ (SE) for […]

Jun 23, 2020 | Industry Press Releases
Philips receives FDA premarket approval for its HeartStart FR3 and HeartStart FRx automated external defibrillators

Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced that the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) for the company’s HeartStart FR3 [1] and HeartStart FRx [2] automated external defibrillators (AEDs), and their supporting accessories, including batteries […]

Jun 16, 2020 | Industry Press Releases
BIOTRONIK Announces its Gradual Launch of His-Bundle Pacing Tools to Allow Physicians More Choices in Achieving Physiological Pacing

BIOTRONIK has today announced its commitment to giving physicians additional tools to pace in the His-Bundle, coinciding with the launch of its His-Bundle Pacing (HBP) tools in a limited number of centers starting now with a full launch later in 2020.

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