New data presented for the first time at the World Heart Federation’s World Congress of Cardiology 2014 shows a significant improvement in both patient adherence and risk factor control when patients at high risk of heart attack or stroke receive a polypill, compared to usual care.
Kalila Medical received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Vado steerable introducer sheath used during atrial fibrillation (AF) and other procedures requiring vascular and intracardiac access.
Datascope Corp./Maquet initiated a voluntary worldwide field correction of some of its intra-aortic balloon pumps (IABPs) due to a potential mechanical failure of the fan assembly associated with the power supply. All customers that may have an IABP affected by this field correction have been notified. The company says there are about 12,360 affected units sold globally.
Providing exceptional cardiovascular care for patients to achieve the best possible outcomes is the number one goal for ...
Medical device executives from across the region are not sure the influx of new patients using their devices and the promised sales boost expected from the Affordable Care Act (ACA) will offset the costs of the ACA’s medical device tax, according to a new survey analysis presented to more than 350 medical technology leaders at UMass-Boston at the Massachusetts Medical Device Industry Council’s (MassMEDIC) 17th annual conference.
InspireMD Inc. initiated a Voluntary Field Action (VFA) following recent reports of MGuard Prime EPS (embolic protection systems), stent dislodgements.
A quarter century ago, doctors treating patients with implanted cardiac pacemakers had a big problem. Their patients were outliving the complex electrical devices that gave them an acceptable quality of life.
Cardiac positron emission tomography (PET) is growing in popularity among cardiologists because it provides the ability ...
May 8, 2014 — Abbott announced its catheter-based MitraClip therapy has received Health Canada approval, providing physicians in Canada with the treatment option that can significantly improve symptoms, disease progression and quality of life for certain people with mitral regurgitation (MR).
May 8, 2014 — The past year has been a turbulent one for U.S. physicians, according to the 2014 Practice Profitability Index (PPI). Approximately 5,064 physicians contributed their insights to the second annual PPI in March 2014.
Argon Medical Devices Inc. began marketing the CelanerXT rotational thrombectomy system as a new addition to the Cleaner family of dialysis products.
When performing radiofrequency (RF) ablation to treat cardiac arrhythmia, medical professionals must balance the safety ...
The Food and Drug Administration (FDA) has granted Biotronik approval for its Entovis pacemaker system with ProMRI technology.
May 7, 2014 — Cardiotek B.V. today announced it will commence commercialization of its EP-Tracer system following the 2014 Heart Rhythm Society (HRS) annual scientific sessions in San Francisco.
May 7, 2014 — Women face greater limits on their lifestyle and have more severe symptoms as a result of peripheral artery disease (PAD), but minimally invasive procedures used to unclog arteries are just as successful as in men. The success of procedures, such as angioplasty or stent placement, in treating women with leg PAD was revealed in a Journal of the American College of Cardiology study.
Change Healthcare Cardiology Hemodynamics is an integrated hemodynamic monitoring system for monitoring vital signs and ...
HeartWare Intl. Inc. issued a voluntary Urgent Medical Device Correction related to all HeartWare Ventricular Assist System batteries, product codes 1650 and 1650-DE.
GE Healthcare received U.S. Food and Drug Administration (FDA) clearance for its Discovery IGS 740, a new rail-free mobile angiography system with a 41x41 cm detector.
The need for improved interoperability between healthcare IT systems and medical devices has been a growing problem in an increasingly integrated medical field. This is especially true in light of U.S. healthcare reform requirements, meaningful use demands and new rules requiring software integrations to receive reimbursements from the Centers for Medicare and Medicaid Services (CMS). Physicians are trained to treat patients, not to deal with IT integration issues, and many ask why they cannot access information they need from the Internet from anywhere, the same way they do on smartphones or their home computers. Until recently, this same level of connectivity has been elusive with their own hospitals’ IT systems. Over the past couple years, vendors have answered this question by launching Web-based