Regulatory

Baxter Announces U.S. FDA Approval and Launch of Ready-to-use Cardiovascular Medicine Norepinephrine in Premix Formulation

First and only manufacturer-prepared premix formulation of norepinephrine available Offers variety of storage options under refrigeration and at room temperature, allowing drug to be placed closer to patient care settings Ready-to-use format means less chance of compounding errors and touch contamination associated with compounded drug formulations DEERFIELD, Ill.–(BUSINESS WIRE)–Baxter International […]

FDA APPROVES ABBOTT’S EPIC™ PLUS TISSUE VALVES FOR PEOPLE IN NEED OF MITRAL OR AORTIC VALVE REPLACEMENT

– New enhancements to Abbott’s Epic valve – the most widely used mitral tissue heart valve in the U.S. and globally – can improve implantation and allow compatibility for future transcatheter valve procedures – Epic Plus designed to help patients with more complex cases of aortic or mitral regurgitation or […]

Abbott Receives FDA Approval for Minimally Invasive Portico™ with FlexNav™ TAVR System to Treat Patients with Aortic Valve Disease

– Transcatheter aortic valve replacement (TAVR) procedure treats people with symptomatic, severe aortic stenosis who are at high or extreme risk for open-heart surgery – With Portico approval, Abbott offers the industry’s most comprehensive portfolio of structural heart solutions in the U.S. ABBOTT PARK, Ill., Sept. 20, 2021 /PRNewswire/ — Abbott (NYSE: ABT) […]

Neovasc Announces FDA Approval of COSIRA-II Clinical Trial

Company on Schedule to Commence Trial Late This Year VANCOUVER and MINNEAPOLIS, Sept. 16, 2021 (GLOBE NEWSWIRE) — via NewMediaWire — Neovasc Inc. (“Neovasc” or the “Company”) (Nasdaq, TSX: NVCN) announced today that it has received FDA approval for the Investigational Device Exemption (“IDE”) regarding the COSIRA-II IDE Clinical Trial. Following multiple discussions with FDA […]

FDA grants Jardiance® Breakthrough Therapy designation for heart failure with preserved ejection fraction

– Designation is based on results from the EMPEROR-Preserved phase III trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with preserved ejection fraction RIDGEFIELD, Conn. and INDIANAPOLIS, Sept. 9, 2021 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) granted Breakthrough […]

TransMedics Receives FDA Approval for its OCS Heart System Enabling Broader Utilization of Donor Hearts for Transplantation in the U.S.­

ANDOVER, Mass., Sept. 7, 2021 /PRNewswire/ — TransMedics Group, Inc. (“TransMedics”) (Nasdaq: TMDX), a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart, and liver failure, today announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) of its OCS Heart System for […]

FDA Approves First-of-Its-Kind Stroke Rehabilitation System

SILVER SPRING, Md., Aug. 27, 2021 /PRNewswire/ — The U.S. Food and Drug Administration today approved the MicroTransponder Vivistim Paired VNS System (Vivistim System), a first-of-its-kind, drug-free rehabilitation system intended to treat moderate to severe upper extremity motor deficits associated with chronic ischemic stroke—a stroke caused by a blockage of blood flow […]

Medtronic Announces FDA Approval of Next-Gen TAVR System for Treatment of Symptomatic Severe Aortic Stenosis

Evolut™ FX TAVR System Adds Innovative Features to Enhance Ease-of-Use and Predictable Valve Deployment DUBLIN, Aug. 24, 2021 /PRNewswire/ — Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced U.S. Food and Drug Administration (FDA) approval of its newest-generation, self-expanding transcatheter aortic valve replacement (TAVR) system, the Evolut™ FX TAVR system. […]

MFDS Greenlights VUNO Med®-DeepCARS™, AI Medical Device for Cardiac Arrest Prediction

SEOUL, South Korea, Aug. 24, 2021 /PRNewswire/ — South Korean artificial intelligence (AI) developer, VUNO Inc. announced today that it has received regulatory approval from the Ministry of Food and Drug Safety (MFDS) for its VUNO Med®–DeepCARS™, an AI medical device for cardiac arrest prediction through vital signs. VUNO Med®–DeepCARS™ is a […]

FDA Approves Expanded Peripheral Artery Disease (PAD) Indication for XARELTO® (rivaroxaban) Plus Aspirin to Include Patients After Lower-Extremity Revascularization (LER) Due to Symptomatic PAD

XARELTO® is the first and only therapy indicated for both coronary artery disease (CAD) and PAD, now including PAD patients post-LER XARELTO® is the only anticoagulant in 20 years to show significant benefit in patients with PAD who remain at high risk for major thrombotic events, including acute limb ischemia […]