News
Medtronic Completes Enrollment in Landmark U.S. Study of Symplicity Renal Denervation System for Treatment-Resistant Hypertension
May 23, 2013 6:06 am | by The Associated Press | CommentsMedtronic, Inc., today announced it has finished randomizing Symplicity HTN-3, the company's pivotal U.S. clinical trial of the Symplicity renal denervation system for treatment-resistant hypertension. Renal denervation is a minimally invasive, catheter-based procedure to reduce activity of the renal (kidney) nerves, which are part of the sympathetic nervous system and help regulate blood pressure.
InspireMD's MGuard Embolic Protection Stent (EPS) Shows Lower Mortality Rate in STEMI Patients at Six Months Compared to Control Group
May 23, 2013 6:00 am | by PR Newswire | CommentsInspireMD, Inc., the leader in embolic protection stents, today announced new 6-month results from the MASTER (MGuard for Acute ST Elevation Reperfusion) trial demonstrating that the MGuard Embolic Protection Stent (EPS) outperformed bare metal and drug eluting stents in all-cause mortality in ST segment elevation myocardial infarction (STEMI) patients.
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 | CommentsSAN 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...
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 | CommentsST. 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...
Consumer Information on: Selenia Dimensions 3D System - P080003S001
May 23, 2013 12:00 am | by U.S. Food & Drug Administration | CommentsThe 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.
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 | CommentsOn 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.
New Michigan-Based Medical Product Manufacturing Effort Provides Solutions for Innovators
May 22, 2013 5:27 pm | by The Associated Press | CommentsThe 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...
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 | CommentsACTON, 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.
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 | CommentsPARIS, 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...
Is There Finally A Way To Stop Severe Excessive Sweating?
May 22, 2013 12:00 pm | by PR Newswire | CommentsNEW 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 | CommentsMauna 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,...
Stryker Extends Co-Marketing Agreement With OrthoSensor Inc.
May 22, 2013 11:12 am | by The Associated Press | CommentsStryker 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...
Surgical Adhesive Offers Hope of Easier Healing Following Mastectomy Procedures
May 22, 2013 11:09 am | by Cohera Medical Inc. | CommentsCohera 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.
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 | CommentsPARIS & 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....
WCUI's Psoria-Shield® Announces Sales Roll-Out of Psoria-Light® to Key Markets
May 22, 2013 11:00 am | by PR Newswire | CommentsSCHAUMBURG, Ill., May 22, 2013 /PRNewswire/ -- Wellness Center USA, Inc. (OTCQB: WCUI), a Schaumburg, IL – alternative healthcare company, is pleased to announce that wholly-owned subsidiary Psoria-Shield has rolled out its domestic sales program for Psoria-Light and...
