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Press Releases

GLEN MILLS, Pa., Oct. 17, 2017 — Unequal®, a leading manufacturer of sports protective gear, announced that the Food and Drug Administration has determined that Unequal's patented HART® CC Pad device, found in every Unequal HART chest protector, can improve safety on the playing field.

NEW YORK, October 4, 2017 — Peerbridge Health Inc., a Health IT company, announced today that its first product, The Peerbridge Cor™ System—a wireless electrocardiogram (ECG) monitor—has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

DUBLIN — October 9, 2017 — Medtronic plc (NYSE: MDT) today announced that it has received U.S. Food and Drug Administration (FDA) approval for the Endurant(TM) II/IIs stent graft system to treat abdominal aortic aneurysm (AAA) patients with neck lengths down to 4mm and <=60° infra-renal angulation when used in combination with the Heli-FX(TM) EndoAnchor(TM) system.

SAN CLEMENTE, Calif., Oct. 4, 2017 — ROX Medical, Inc., a privately held medical device company pioneering an innovative interventional vascular therapy for Uncontrolled Hypertension, announced today that the first patient was treated in the CONTROL HyperTeNsion (HTN)-2 clinical study, the Company's pivotal study to evaluate the safety and effectiveness of the ROX Coupler used to create an arterio-venous anastomosis in the iliac vessels, in patients with high blood pressure.

PLAINSBORO, N.J., Sept. 29, 2017 — Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) approved Fiasp® (insulin aspart injection) 100 Units/mL, a fast-acting mealtime insulin indicated to improve glycemic control in adults with type 1 and type 2 diabetes.

Medtronic plc (NYSE: MDT) has received U.S. Food and Drug Administration (FDA) approval for its HeartWare(TM) HVAD(TM) System as a destination therapy for patients with advanced heart failure who are not candidates for heart transplants. The HVAD System, a left ventricular assist device or LVAD, helps the heart pump and increases the amount of blood that flows through the body.

MARLBOROUGH, Mass., Sept. 25, 2017 — Boston Scientific (NYSE: BSX) has launched the Resonate™ family of implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) systems featuring the HeartLogic™ Heart Failure Diagnostic to help physicians improve heart failure (HF) management.

Boston Scientific (NYSE: BSX) today announced new data from the Multisensor Chronic Evaluation in Ambulatory Heart Failure Patients (MultiSENSE) study evaluating the performance of the HeartLogic™ Heart Failure Diagnostic to predict impending heart failure (HF) decompensation.

LEXINGTON, Mass., Sept. 14, 2017 — G3 Pharmaceuticals, a newly formed biopharmaceutical company located in Lexington, MA, today announced the start of its research and development program to pursue novel galectin-3 inhibitors.   Galectin-3 is a protein that is responsible for fibrosis forming in the heart and kidney, which impairs organ function, leading to heart failure, atrial fibrillation, and impaired kidney function.

Amgen (NASDAQ:AMGN) today announced that a new analysis of the cardiovascular outcomes study (FOURIER) demonstrated that lowering low-density lipoprotein cholesterol (LDL-C) levels with Repatha® (evolocumab) significantly and consistently reduced cardiovascular events in patients with and without diabetes at baseline.

September 14, 2017 — A global team of researchers reported in the New England Journal of Medicine that the study did not meet its primary efficacy endpoint, but yielded important results for all-cause mortality.

Zywie’s Next-Generation Remote Cardiac Monitoring Solution Revolutionizing Decades-Old Solution

 

DUBLIN and LAS VEGAS — September 12, 2017 — Medtronic plc (NYSE: MDT) data announced today reinforce the durability and safety of the IN.PACT(TM) Admiral(TM) drug-coated balloon (DCB) in patients with peripheral arterial disease (PAD).

DUBLIN — September 8, 2017 — Medtronic plc (NYSE: MDT) today announced that the IN.PACT(TM)Admiral(TM) Drug-Coated Balloon (DCB) received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of peripheral artery disease (PAD) in the upper leg - specifically, in the thigh (superficial femoral arteries (SFA)) and behind the knee (popliteal arteries).

The Food and Drug Administration (FDA) has cleared TrueFusion, a new cardiovascular application from Siemens Healthineers that integrates ultrasound and angiography images to guide cardiac teams when administering treatment for structural heart disease.

ABBOTT PARK, Ill., Aug. 30, 2017 — Abbott (NYSE: ABT) today announced it has initiated a U.S. pivotal clinical study evaluating the safety and effectiveness of a modified version of its AMPLATZER™ device designed to correct a common congenital heart defect that occurs in approximately 80,000 pre-term infants in the U.S. each year.

DANVERS, Mass., Aug. 28, 2017 — Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support and recovery technologies, announced today that it has accepted the resignation of its Chief Financial Officer, Michael Tomsicek, effective August 24, 2017. After two years, Mr. Tomsicek is leaving the Company to pursue other interests.

ABBOTT PARK, Ill., Aug. 28, 2017 — Abbott (NYSE: ABT) announced today it has received U.S. Food and Drug Administration (FDA) approval for its Full MagLev™ HeartMate 3 Left Ventricular Assist System (also known as an LVAD).

MURRAY HILL, N.J. — August 28, 2017 — C. R. Bard, Inc. (NYSE:BCR) today announced the LUTONIX® 035 Drug Coated Balloon PTA Catheter (DCB) has been granted premarket approval (PMA) by the U.S. Food and Drug Administration (FDA) for a new indication and is now available for sale in the United States. With this approval, the LUTONIX® 035 DCB Catheter becomes the first and only drug coated balloon that is FDA approved as safe and effective in end stage renal disease (ESRD) patients with stenotic lesions in dialysis arteriovenous (AV) fistulae.

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