News
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...
Small Increase in Cancer Risk Following CT Scans in Childhood and Adolescence
May 22, 2013 10:44 am | by University of Melbourne | CommentsStudy leader, Professor John Mathews from the University of Melbourne said this small increase in cancer risk must be weighed against the undoubted benefits from CT scans in diagnosing and monitoring disease. The study findings are reported in the British Medical Journal today and involved researchers at eight other centres in Australia, Oxford University, and the International Agency for Research on Cancer in Lyon, France.
Evaluating a New Way to Open Clogged Arteries
May 22, 2013 10:42 am | by Anne Trafton, MIT News Office | CommentsOver the past few decades, scientists have developed many devices that can reopen clogged arteries, including angioplasty balloons and metallic stents. While generally effective, each of these treatments has drawbacks, including the risk of side effects. A new study from MIT analyzes the potential usefulness of a new treatment that combines the benefits of angioplasty balloons and drug-releasing stents, but may pose fewer risks.
UofL Scientists Uncover How Grapefruits Provide a Secret Weapon in Medical Drug Delivery
May 22, 2013 10:38 am | by University of Louisville | CommentsUniversity of Louisville researchers have uncovered how to create nanoparticles using natural lipids derived from grapefruit, and have discovered how to use them as drug delivery vehicles. UofL scientists Huang-Ge Zhang, D.V.M., Ph.D., Qilong Wang, Ph.D., and their team published their findings in Nature Communications.
Single-Cell Transfection Tool Enables Added Control for Biological Studies
May 22, 2013 10:36 am | by Northwestern University | CommentsNorthwestern University researchers have developed a new method for delivering molecules into single, targeted cells through temporary holes in the cell surface. The technique could find applications in drug delivery, cell therapy, and related biological fields.
