Press Releases

NIJMEGEN, Netherlands--(BUSINESS WIRE)--Following successful clinical trials in 2015, NovioSense BV, today announced they had closed their 4th financing round for the next clinical validation phase of their smartphone based tear glucose sensor device, to provide an accurate, pain-free and conveniently placed glucose sensor to address the growing diabetes epidemic impacting people’s lives and overwhelming healthcare systems worldwide.

JUPITER, Fla., Oct. 4, 2016 /PRNewswire/ -- Somahlution, a global biotechnology company leading the development of products to reduce the burden of ischemia reperfusion injury in tissue grafting, organ transplant and other surgical indications, today announced presentation of new data showing the company's DuraGraft® vascular graft treatment significantly improves long-term outcomes in coronary artery bypass grafting (CABG) surgery.

MISSISSAUGA, Ontario – October 3, 2016 – Aralez Pharmaceuticals Inc. (NASDAQ: ARLZ) (TSX: ARZ), a global specialty pharmaceutical company, announced today the availability of once-daily YOSPRALA™, the only prescription fixed-dose combination of aspirin, an anti-platelet agent, and omeprazole, a proton pump inhibitor (PPI), in the U.S. YOSPRALA is indicated for patients who require aspirin for secondary prevention of cardiovascular (CV) and cerebrovascular events and who are at risk of developing aspirin associated gastric ulcers. YOSPRALA is being promoted by 110 sales representatives in the U.S. and is currently available in the wholesale chain.

CAESAREA, Israel and TAMPA, Fla., Oct. 3, 2016 /PRNewswire/ -- Keystone Heart Ltd., an emerging medical device company focused on developing cerebral protection devices for patients undergoing cardiovascular procedures, announces data recently published in the American Journal of Cardiology demonstrating new brain lesions in 94% of patients undergoing transcatheter aortic valve replacement (TAVR) by diffusion weighted magnetic resonance imaging (DWI-MRI) (n=34) prior to hospital discharge.

Marlborough, MA, October, 3, 2016 – Today, GE Healthcare announced that the U.S. Food and Drug Administration (FDA) has approved a label change for the ultrasound contrast agent Optison™ (Perflutren protein-Type A Microspheres Injectable Suspension, USP).

DANVERS, Mass., Sept. 27, 2016 (GLOBE NEWSWIRE) -- Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support technologies, announced today that the Impella 2.5 and Impella 5.0 heart pumps received Pharmaceuticals and Medical Devices Agency (PMDA) approval from the Japanese Ministry of Health, Labor & Welfare (MHLW) for the treatment of drug-resistant acute heart failure.

MARLBOROUGH, Mass., September 27, 2016 – CardioFocus, Inc. today announced the first commercial U.S. procedure using its HeartLight® Endoscopic Ablation System for the treatment of patients with paroxysmal atrial fibrillation (AF) at The Mount Sinai Hospital in New York City. The HeartLight® System received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) in April 2016. This procedure marks the initiation of the company’s commercialization of the system in the large and growing U.S. AF market.

CDC is teaming up with a broad coalition of kidney and dialysis organizations to reduce the number of bloodstream infections in dialysis patients. Each year, about 37,000 people get potentially deadly bloodstream infections related to their dialysis treatment.

DANVERS, Mass., Sept. 27, 2016 (GLOBE NEWSWIRE) -- Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support technologies, announced today that the Impella 2.5 and Impella 5.0 heart pumps received Pharmaceuticals and Medical Devices Agency (PMDA) approval from the Japanese Ministry of Health, Labor & Welfare (MHLW) for the treatment of drug-resistant acute heart failure.

September 21, 2016 – SpringBoard Healthcare is now taking responses for its nationwide wage survey of nurses, technicians and specialists working in cardiac catheterization, electrophysiology and interventional radiology labs. Considered the gold standard of wage surveys for the industry, it is designed to gather comprehensive insight into the salaries and wages of employees in that sector. The results, based on data from thousands of participants, highlight salary and wage differences by job type, experience, facility type, credentials and state and region.

SOUTH SAN FRANCISCO, Calif., Sept. 21, 2016 (GLOBE NEWSWIRE) -- MyoKardia, Inc. (Nasdaq:MYOK), a clinical stage biopharmaceutical company pioneering a precision medicine approach for the treatment of heritable cardiovascular diseases, will highlight today the expected path to registration for its lead product candidate MYK-461 in the initial indication of symptomatic oHCM and its plans to progress MYK-491 into the clinic for DCM.

LOMA LINDA, CA., September 20, 2016 – Loma Linda University researcher Gordon G. Power, together with a team of researchers from several other universities, has received a patent from the U.S. Patent and Trademark Office for the use of nitrite salts to treat specific cardiovascular conditions. The discovery was made through ongoing research and with government support under Grant Nos. HL58091 and HL70146, awarded by the NIH.

DUBLIN - September 15, 2016 - Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced the publication of its Hybrid Closed Loop system pivotal trial results in the Journal of the American Medical Association (JAMA). The data presented the safety of the system and showed that patients on the therapy experienced less glycemic variability, more time in the target range, less exposure to hypoglycemia and hyperglycemia, and reduced A1c compared to baseline data using sensor augmented pumps.1 The data was concurrently presented at the 52nd annual meeting of the European Association for the Study of Diabetes (EASD) in Munich, Germany. 

SANTA ROSA, Calif. – September 14, 2016 – Claret Medical®, an innovator in filter-based cerebral embolic protection technologies, today announced that data from its SENTINEL pivotal IDE trial has been accepted for the Late-Breaking Clinical Trial session at the 28th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, being held October 29 to November 2 in Washington, DC.

COLUMBIA, Md., Sept. 13, 2016 (GLOBE NEWSWIRE) -- Digital health technology leader WellDoc announced today it has entered a commercial partnership agreement withLifeScan Inc., one of the Johnson & Johnson Diabetes Care Companies (JJDCC) and a world leader in blood glucose monitoring, to deliver across the United States a best-in-class digital health solution for Type 2 diabetes.

Broomfield, CO, Sept. 13, 2016 (GLOBE NEWSWIRE) -- Colibri Heart Valve LLC, a privately held emerging medical device company focused on structural heart applications, has entered into definitive documents with Venus Medtech (Hangzhou) Inc., the preeminent Chinese transcatheter heart valve company, to establish a joint venture. Under the terms of the agreement, Colibri and Venus Medtech will share in the ownership and management of a newly created joint venture entity (JVE) formed to develop and commercialize structural heart valve products for the Chinese and emerging Asia markets. 

DUBLIN - September 12, 2016 -   Two Medtronic plc (NYSE: MDT) innovations were acknowledged in updated guidelines published by the European Society of Cardiology (ESC): cryoballoon ablation for patients with diagnosed atrial fibrillation (AF), and long-term cardiac monitoring for survivors of stroke who do not have an established diagnosis of AF.

ST. LOUIS, Aug. 31, 2016 /PRNewswire/ -- Express Scripts (NASDAQ: ESRX) today announced the launch of its Diabetes Care Value Program℠, the industry's most comprehensive approach to improve pharmacy care while controlling plan costs for people with diabetes.

(PresseBox) EPIC Alliance experts at the European Society of Cardiology (ESC) congress presented original research and real-world clinical evidence on non-responders to cardiac resynchronization therapy (CRT) and atrial fibrillation (AF) ablation today.

(PresseBox) During a scientific talk at the 2016 European Society of Cardiology (ESC) Congress, Dr. Gerhard Hindricks, Leipzig Heart Center, Germany, presented results of a meta-study showing that BIOTRONIK Home Monitoring® is associated with a 38 percent reduced risk for all-cause mortality after one year in all ICD patients. 

WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) praised several process improvements included in the recently announced medical device user fee agreement with FDA, stressing they would lead to greater efficiency, consistency and accountability in the agency’s device review process.