July 29, 2011 — InspireMD Inc., developer of the MGuard mesh protective stent system, announced that the first patient has been enrolled in the MASTER (MGuard for Acute ST Elevation Reperfusion) randomized trial. It is a multinational, randomized, controlled trial designed to demonstrate MGuard coronary stent's superiority over standard care for heart attack patients.

July 29, 2011 — Oxygen Biotherapeutics Inc. and privately held Aurum Biosciences Ltd. of Glasgow, Scotland, have signed a letter of intent (LOI) to conduct preclinical research for imaging and therapeutic intervention of acute ischemic stroke. Aurum, using Oxygen’s proprietary Oxycyte PFC (perfluorocarbon) emulsion in combination with Aurum’s proprietary Glasgow Oxygen Level Dependent (GOLD) magnetic resonance imaging (MRI) techniques, will conduct the research.  

July 29, 2011 — Boston Scientific Corporation's board of directors has approved a five-year, $150 million investment to expand its commercial presence in China, one of the world's largest and fastest-growing medical device markets.

July 29, 2011 — The U.S. Food and Drug Administration (FDA) this week issued draft guidance that clarifies when changes or modifications to a previously cleared 510(k) device require a new premarket submission.

July 27, 2011 – Micell Technologies Inc. announced that it has completed patient enrollment in its DESSOLVE II CE mark clinical study of the MiStent drug-eluting coronary stent system. The MiStent DES is an ultra-thin drug-eluting stent distinguished by a rapid-absorbing drug/polymer coating formulation. Enrollment of 183 patients across 26 study centers throughout Europe and New Zealand was accomplished ahead of schedule.

July 27, 2011 – A special panel convened July 21 in Gaithersburg, Md., to review the results of the Excor pediatric ventricular assist device (VAD) investigational device exemption (IDE) clinical trial. The panel convened at the request of Bram Zuckerman, M.D., director, division of cardiovascular devices, Center for Devices and Radiologic Health of the U.S. Food and Drug Administration (FDA).

July 27, 2011 – A new echocardiography remote reading program was introduced to provide expert exam interpretation in all 50 states. The new program, created by USARAD.com, a Joint Commission accredited provider of imaging services, is intended to address the longstanding need for fast, reliable interpretation of echocardiograms for mobile ultrasound companies and other imaging facilities across the nation.

July 27, 2011 – As the number of interventional procedures to diagnose and treat patients increases worldwide, and the procedures grow in complexity and length, exposure to radiation is a growing concern for both clinicians and patients. Interventional fluoroscopy is the third largest source of radiation from medical procedures, accounting for about 7 percent of the total radiation exposure of Americans in a year, according to a study by the National Council on Radiation Protection. GE’s Innova imaging systems help clinicians reduce radiation exposure without compromising the image quality they need to make confident decisions during interventional procedures.

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