News

Biotronik announced that the U.S. Food and Drug Administration (FDA) has approved, with conditions, the ProMRI clinical trial via an Investigational Device Exemption. Biotronik is sponsoring the trial (NCT01761162) and has already initiated U.S. site recruitment. The ProMRI clinical trial is designed to recruit 245 subjects implanted with one of Biotronik’s cardiac devices that include ProMRI technology at 30 U.S. investigational centers.

Home January 22, 2013
Home
Technology

GNAX Health announced the availability of GNAX SDEX Secure digital imaging and communications in medicine (DICOM) Exchange, allowing hospitals, ACOs and HIEs the ability to transfer medical images securely. The announcement was made by Jeff Hinkle, CEO, GNAX, at the Radiological Society of North America's 98th Scientific Assembly and Annual Meeting in Chicago, Ill.

Home January 21, 2013
Home
News

January 21, 2013 — ECRI Institute, a nonprofit organization that researches the best approaches to improving patient care, recently evaluated evidence behind the use of the only transcatheter heart valve approved for marketing in the United States and Europe in transcatheter aortic valve implantation (TAVI).

Home January 21, 2013
Home
Technology

January 21, 2013 — Avreo announced it has formed a partnership with VidiStar LLC, a provider of cardiology medical imaging and reporting solutions using the latest technological standards for image interpretation, clinical analysis and medical reporting.

Home January 21, 2013
Home
News

The first patient has been treated in the Boston Scientific Corporation ZERO AF clinical trial to evaluate the safety and effectiveness of the Blazer open-irrigated temperature ablation Catheter in patients with symptomatic, drug refractory paroxysmal atrial fibrillation. This international, multi-center study will include up to 33 sites in the United States, Europe and Asia-Pacific, and as many as 472 patients. The results of the ZERO AF trial are expected to be used to support a U.S. Food and Drug Administration (FDA) regulatory submission for a paroxysmal atrial fibrillation indication.

Home January 21, 2013
Home
News

At the Boston Atrial Fibrillation (AF) Symposium 2013, Philips Healthcare introduced its latest innovations in advanced imaging integration for electrophysiologists, showcasing its new EP navigator offering — a novel approach to 3-D rotational angiography that provides real-time anatomical details of cardiac LA-PV structures with significantly enhanced workflow.

Home January 21, 2013
Home
News

GE Healthcare announced that it has filed a supplemental new drug application (sNDA) that will allow the company to manufacture Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP), within its own facility. Optison is a contrast agent that may improve the visualization of the left ventricular border — an area of the heart that is critical to see in order to assess and diagnose certain heart diseases. Upon approval, GE Healthcare will provide supply of Optison to the U.S. market from its manufacturing facility in Oslo, becoming the only contrast media manufacturer to supply its own stock for the United States.

Home January 18, 2013
Home
Technology

nContact Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s modifications to its VisiTrax cardiac ablation device, EPi-Sense, now with embedded sensing capability. This next generation of technology includes sensors along the ablation device, which provide real-time feedback to physicians conducting cardiac ablation procedures.

Home January 18, 2013
Home
News

CardioMEMS Inc. has been honored as the 2012 recipient of the Intel Innovation Award. Founder and CEO Jay Yadav, M.D., was presented with the award on Dec. 4, 2012 during the annual Health IT Leadership Summit held at the historic Fox Theatre in Atlanta, Ga.

Home January 18, 2013
Home
CardioKinetics PARACHUTE IV Clinical Trial Heart Failure Treatments
Feature

CardioKinetix Inc. announced the enrollment of the first patients in PARACHUTE IV, the randomized pivotal U.S. trial of the minimally invasive Parachute Ventricular Partitioning Device for the treatment of heart failure.

Home January 18, 2013
Home
News

GSI Group Inc., a leading supplier of laser-based solutions, precision motion and optical technologies to global industrial, medical, electronics and scientific markets, announced that it has acquired NDS Surgical Imaging (NDS), a San Jose, Calif.-based global leader in surgical and radiology displays and related peripherals, for $82.5 million in cash, subject to customary closing adjustments.

Home January 17, 2013
Home
Feature

Covidien began the commercial launch of the OneShot Renal Denervation System, an over the wire balloon-based irrigated ablation catheter technology for the treatment of hypertension.

Home January 16, 2013
Home
electronic health records, MU
Feature

The American Medical Association (AMA) submitted formal comments to the Office of the National Coordinator for Health Information Technology (ONC) on the Health IT Policy Committee’s proposal for Stage 3 of the Medicare/Medicaid meaningful use electronic health record (EHR) program requirements.

Home January 16, 2013
Home
News

Open heart surgery may be a dying art, as new valve replacement techniques offer life-changing treatment without the need for invasive procedures, states a new report by healthcare experts GlobalData.

Home January 16, 2013
Home
Technology

Lantheus Medical Imaging Inc. has added a low-enriched uranium (LEU) TechneLite (technetium Tc 99m Generator) generator to the its nuclear imaging product portfolio. Lantheus’ LEU TechneLite generator is the first technetium-99m (Tc-99m) generator in the United States that contains molybdenum-99 (Mo-99) produced from at least 95 percent LEU. With greater access to LEU Mo-99 through its supply chain diversification strategy, Lantheus can now move closer to its goal of eventually eliminating Highly Enriched Uranium (HEU)-sourced Mo-99 from its supply chain. Lantheus’ first LEU TechneLite generator was shipped on Jan. 7, 2013.

Home January 16, 2013
Home
Subscribe Now