– New labeling approval for Abbott’s XIENCE™ stent builds on a legacy of safety and allows for one-month (as short as 28 days) dual anti-platelet therapy (DAPT) for patients at high bleeding risk (HBR) – The new XIENCE Skypoint™ stent […]
Tag: FDA
AngelMed Announces FDA Approval of the Enhanced Real-Time Cardiac Monitor for Acute Coronary Syndrome (ACS) Events
AngelMed Guardian® System prompts high-risk ACS patients to seek medical care EATONTOWN, N.J., June 28, 2021 /PRNewswire/ — Angel Medical Systems, Inc., (dba AngelMed) a proactive diagnostics company focused on the advancement of long-term management of high-risk coronary disease, announced today the FDA […]
Penumbra Announces FDA Clearance and Commercial Availability of RED 62 Reperfusion Catheter
Now available in the U.S., RED™ 62 is engineered with optimized trackability to help navigate the complex distal vessel anatomy in the brain and deliver powerful aspiration for the removal of blood clots First catheter of new RED series expands the […]
Caretaker Medical selected for MedTech Innovator’s Global Top 50 Medical Device Startup Showcase
Charlottesville, VA June 22, 2021 – Caretaker Medical, developer of the Caretaker™ Wireless Hemodynamic Patient Monitor has been selected for MedTech Innovator’s Annual Showcase and Accelerator for 2021. Caretaker Medical was selected from a field of over 1100 companies across […]
Sensome Receives FDA “Breakthrough Device Designation” for its AI-powered Stroke Guidewire
PARIS–(BUSINESS WIRE)–Sensome, the company pioneering the connected medical device revolution with the world’s smallest biological tissue sensor, announced today that it has been granted a Breakthrough Device designation by the Center of Devices and Radiological Health (CDRH) of the Food […]
Medtronic Receives FDA Expanded Approval for Arctic Front™ Family of Cardiac Cryoablation Catheters for Initial Use for Recurrent Symptomatic Paroxysmal Atrial Fibrillation
– First and Only Approval to Indicate Cryoablation as an Initial Rhythm Control Strategy – Offers Safe, Effective Alternative to Antiarrhythmic Drug Therapy for the Prevention of Atrial Arrythmia Recurrence DUBLIN, June 21, 2021 /PRNewswire/ — Medtronic plc (NYSE: MDT), the global leader in […]
United Therapeutics Announces FDA Acceptance of Tyvaso DPI™ New Drug Application For Priority Review
FDA action expected in October 2021 SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., June 16, 2021 /PRNewswire/ — United Therapeutics Corporation (Nasdaq: UTHR) today announced that the U.S. Food and Drug Administration (FDA) accepted for priority review the New Drug Application (NDA) for Tyvaso […]
Neurescue’s Breakthrough Intelligent Balloon Catheter FDA 510(k) Cleared for Hemorrhage Control and IDE Approved for Cardiac Arrest
Device is FDA IDE approved to start a clinical study in the U.S. to investigate a novel cardiac arrest treatment indication COPENHAGEN, Denmark–(BUSINESS WIRE)–Neurescue, a medical device company developing innovative cardiovascular solutions to improve the outcomes for emergency patients, today […]
FDA Alerts Health Care Providers to Stop New Implants of Certain Ventricular Assist Device System
SILVER SPRING, Md., June 3, 2021 /PRNewswire/ — The U.S. Food and Drug Administration is alerting health care providers to no longer implant end-stage heart failure patients with Medtronic’s Heartware Ventricular Assist Device (HVAD) System due to a growing body of observational clinical comparisons […]
Liquidia Announces FDA Acceptance of New Drug Application Resubmission for LIQ861 (treprostinil) Inhalation Powder
MORRISVILLE, N.C., June 02, 2021 (GLOBE NEWSWIRE) — Liquidia Corporation (NASDAQ: LQDA) announced today that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) resubmission for LIQ861 (treprostinil) inhalation powder to treat pulmonary arterial hypertension […]
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