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Volcano Announces Preliminary Results from the ADVISE II Study and Inclusion in the SYNTAX2 Trial During Hot Line Late Breaking Clinical Trial Sessions at EuroPCR 2013

May 23, 2013 4:30 am | by PR Newswire | News | Comments

SAN DIEGO and PARIS, May 23, 2013 /PRNewswire/ -- Volcano Corporation (NASDAQ: VOLC), a leading developer and manufacturer of precision guided therapy tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, today announced preliminary...

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One Year Data from St. Jude Medical Study Demonstrates Safe, Rapid and Sustained Blood Pressure Reduction with EnligHTN Renal Denervation Technology

May 23, 2013 4:15 am | by The Associated Press | News | Comments

ST. PAUL, Minn. & PARIS--(BUSINESS WIRE)--May 23, 2013--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced that the company’s EnligHTN ™ Multi-Electrode Renal Denervation System provides a safe, rapid and sustained reduction in blood pressure measurements after...

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Meeting Announcement: June 26, 2013 General and Plastic Surgery Devices Panel of the Medical Devices Meeting Announcement

May 23, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

On June 26, 2013, the committee will discuss and make recommendations regarding the possible reclassification of blood lancet devices.  The committee will discuss whether new scientific data are sufficient to support the reasonable assurance of safety and effectiveness to develop special controls that support regulation of blood lancets from class I to class II and class III. 

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Consumer Information on: Selenia Dimensions 3D System - P080003S001

May 23, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The Selenia Dimensions 3D System is comprised of hardware and software upgrades to the Selenia Dimensions 2D full-field digital mammography system, which is FDA approved for conventional mammography. The hardware upgrades produces multiple, low-dose x-ray images of the breast; the software upgrade uses the low-dose x-ray images to create cross-sectional (tomosynthesis) views of the breast.

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New Michigan-Based Medical Product Manufacturing Effort Provides Solutions for Innovators

May 22, 2013 5:27 pm | by The Associated Press | News | Comments

The University of Michigan Pediatric Medical Device Consortium (M-PED) is launching a new medical product manufacturing video on Vimeo. This 28-minute video: "Innovative Pediatric Manufacturing: Strategies & Solutions - A Guide To Bringing Your Device To Market" features critical...

May 2013 Digital Edition

May 22, 2013 4:22 pm | by MDT Staff | Digital Editions | Comments

As medical devices continue to get smaller in size, the assembly of the internal electronics becomes more critical. “Device Shrinkage Achieved Through Consideration of Assembly Factors,” this month’s cover story, looks at this issue and how working earlier with an outsourcing partner can help.

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Replacing the Cadaver for Surgical Students

May 22, 2013 4:06 pm | by Kasey Panetta, Managing Editor, ECN | Articles | Comments

Surgical simulators are an ideal solution for training surgeons with minimal risk to patient health and safety. This is particularly important when surgeons train for procedures utilizing arthroscopy because it requires the surgeon to perform the surgery while looking at a camera screen instead of the patient. This necessitates extensive training to ensure the doctor is an expert in the method.

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Silicon Nitride: A Next Generation Spinal Implant Material (Q&A)

May 22, 2013 2:55 pm | by Sean Fenske, Editor-in-Chief, MDT | Blogs | Comments

Eric Olson is the chief executive officer and president of Amedica, the only company that produces medical grade Silicon Nitride. He took a moment to participate in the following Q&A about the unique material and its impact in medical devices, specifically in the orthopedic implant area.

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Cognoptix Test Identifies Alzheimer’s Disease via Beta Amyloid Signature in the Eyes in Proof-of-Concept Clinical Trial

May 22, 2013 12:53 pm | by The Associated Press | News | Comments

ACTON, Mass.--(BUSINESS WIRE)--May 22, 2013--Cognoptix, an emerging medical device company, announced today that its SAPPHIRE II eye test identified Alzheimer’s disease patients via a beta amyloid (“Ab”) signature in their eyes in a 10-subject proof-of-concept clinical trial.

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New Data Demonstrate Significant And Sustained Blood Pressure Reduction With Boston Scientific Vessix™ Renal Denervation System

May 22, 2013 12:20 pm | by PR Newswire | News | Comments

PARIS, May 22, 2013 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today reported interim data from the REDUCE-HTN clinical program, which demonstrated a significant and sustained reduction in the blood pressure of patients treated with the Vessix™ Renal Denervation...

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Is There Finally A Way To Stop Severe Excessive Sweating?

May 22, 2013 12:00 pm | by PR Newswire | News | Comments

NEW YORK, May 22, 2013 /PRNewswire/ -- For the 3% of the population that suffer from hyperhidrosis, their severely excessive sweating is often embarrassing, uncomfortable, anxiety-inducing and disabling.  While more than half of these people are never diagnosed or treated...

New Data on Cellvizio Presented at DDW 2013 Suggests That Optical Biopsies May Help Confirm and Rule Out Pancreatic Cystic Tumors*

May 22, 2013 11:45 am | by The Associated Press | News | Comments

Mauna Kea Technologies (NYSE Euronext: MKEA), leader in the optical biopsy market and developer of Cellvizio®, the fastest way to see cancer, today announced that optical biopsies using a microscope so tiny it fits through a small needle show clear cellular-level images inside pancreatic cysts,...

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Stryker Extends Co-Marketing Agreement With OrthoSensor Inc.

May 22, 2013 11:12 am | by The Associated Press | News | Comments

Stryker Corporation's Orthopaedics division and OrthoSensor™, Inc., the leader in intelligent orthopedics, today announced an extension of their co-marketing agreement for Stryker's Triathlon Knee System and OrthoSensor's VERASENSE. VERASENSE is an intelligent instrument system that provides...

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Surgical Adhesive Offers Hope of Easier Healing Following Mastectomy Procedures

May 22, 2013 11:09 am | by Cohera Medical Inc. | News | Comments

Cohera Medical, a leading innovator and developer of absorbable surgical adhesives and sealants, announced it has completed a series of mastectomy procedures in Munich and Berlin, Germany using TissuGlu Surgical Adhesive without drain placement. With this innovative adhesive technology, surgeons were able to eliminate the need for closed-suction drains on breast cancer patients undergoing mastectomy procedures.

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CardioKinetix Announces Positive Clinical Data Showing Consistent Compelling Positive Results for Patients Treated with Minimally Invasive Structural Heart Device for Heart Failure

May 22, 2013 11:00 am | by The Associated Press | News | Comments

PARIS & MENLO PARK, Calif.--(BUSINESS WIRE)--May 22, 2013--CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced results of a meta-analysis study of the first-of-its-kind catheter-based Parachute ® Ventricular Partitioning Device....

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