Medical Equipment News 
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This page shows you the most recent publications within this specialty of the MedWorm directory. This is page number 9.
Meeting Announcement: February 22, 2013 Neurological Devices Panel of the Medical Devices Advisory C
Source: Food and Drug Adminstration (FDA): CDRHNew - December 7, 2012 Category: Medical Equipment Source Type: news
Microdrive Manages The Control Valve Of A Portable Measuring Device
Dangerously high blood pressure is a frequently undiagnosed illness in the fast-paced world of today. This is a serious problem, as high blood pressure left untreated for many years can trigger a whole series of secondary diseases and skyrocketing treatment costs.
Source: Medical Design Online News - December 6, 2012 Category: Medical Equipment Source Type: news
Compact, High-Torque Motors Power Handheld, Automated Biopsy System For Speed Of Sampling, Ease Of Use, And Faster Patient Recovery
Breast biopsies have come a long way from the open surgical procedures of decades ago. In today’s procedures, technicians remove the tissue using a several-mm-diameter cannula inserted in the breast.
Source: Medical Design Online News - December 6, 2012 Category: Medical Equipment Source Type: news
Miniature EC Motors Position Nerve Recording Electrodes
"To sound someone out", this phrase is familiar to all of us. In the context of nerve cells, however, some medical scientists have taken this statement literally.
Source: Medical Design Online News - December 6, 2012 Category: Medical Equipment Source Type: news
BSD Medical Reports Significant Quarterly Growth Of MicroThermX Microwave Ablation System Sales And Equipment Utilization
BSD Medical Corporation (Company or BSD) (www.BSDMedical.com), a leading provider of medical systems utilizing heat therapy to treat cancer, announced recently a 586% increase in sales for the MicroThermX® Microwave Ablation System (MicroThermX®) product line for the fiscal quarter ended November 30, 2012, as compared to the fiscal quarter ended November 30, 2011
Source: Medical Design Online News - December 6, 2012 Category: Medical Equipment Source Type: news
International pharmaceutical and medical device guidelines
This guidance provides essential information on how pharmaceutical and medical devices related CO2e emissions can be reduced and sustainable healthcare as a whole facilitated.
Source: NHS Networks - December 6, 2012 Category: UK Health Authors: Maria Axford Source Type: news
Meeting materials posted for December 10, 2012: Neurological Devices Panel of the Medical Devices Advisory Committee Meeting
Source: Food and Drug Adminstration (FDA): CDRHNew - December 6, 2012 Category: Medical Equipment Source Type: news
IRS finalizes new tax for medical devices in healthcare law
WASHINGTON (Reuters) - The U.S. Internal Revenue Service on Wednesday released final rules for a new
tax on medical devices, products ranging from surgical sutures to knee replacement implants, that starts next year
as part of President Barack Obama's 2010 healthcare law.
Source: Modern Medicine - December 6, 2012 Category: Journals (General) Source Type: news
Sorin Group Announces First PARADYM RF Implant And Subsequent First SMARTVIEW Remote Monitoring Activated Patient In North America
Sorin Group, a global medical device company and a leader in the treatment of cardiovascular diseases, announced recently the first implant of PARADYM RF in Canada at the Montreal Heart Institute
Source: Medical Design Online News - December 5, 2012 Category: Medical Equipment Source Type: news
S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent Systems
The S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent Systems are used to re-open narrowed (stenotic) regions of the superficial femoral and proximal popliteal arteries which supply blood to the legs. (Approved: 11/7/2012)
Source: Medical Device Approvals - December 5, 2012 Category: Medical Equipment Source Type: news
HeartWare Ventricular Assist System
The HeartWare Ventricular Assist System (VAS) is a device that helps deliver blood from the heart to the rest of the body. (Approved: 11/20/2012)
Source: Medical Device Approvals - December 5, 2012 Category: Medical Equipment Source Type: news
Abbott Laboratories ARCHITECT AFP Assay, ARCHITECT AFP Calibrators and ARCHITECT AFP Controls
The ARCHITECT AFP Assay is an automated laboratory molecular immunoassay test that measures how much alpha-fetoprotein2 (AFP) is in serum or plasma (blood products) or amniotic fluid. (Approved: 11/28/2012)
Source: Medical Device Approvals - December 5, 2012 Category: Medical Equipment Source Type: news
Summary Information for: S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent Systems
Labeling, Approval Order, and Summary of Safety and Effectiveness for S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent Systems (P120002).
Source: Food and Drug Adminstration (FDA): CDRHNew - December 5, 2012 Category: Medical Equipment Source Type: news
Consumer Information on: S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent Systems - P120002
The S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent Systems are used to re-open narrowed (stenotic) regions of the superficial femoral and proximal popliteal arteries which supply blood to the legs.
Source: Food and Drug Adminstration (FDA): CDRHNew - December 5, 2012 Category: Medical Equipment Source Type: news
Consumer Information on: HeartWare Ventricular Assist System - P100047
The HeartWare Ventricular Assist System (VAS) is a device that helps deliver blood from the heart to the rest of the body.
Source: Food and Drug Adminstration (FDA): CDRHNew - December 5, 2012 Category: Medical Equipment Source Type: news
Summary Information for: HeartWare Ventricular Assist System
Labeling, Approval Order, and Summary of Safety and Effectiveness for HeartWare Ventricular Assist System (P100047).
Source: Food and Drug Adminstration (FDA): CDRHNew - December 5, 2012 Category: Medical Equipment Source Type: news
Summary Information for: Abbott Laboratories ARCHITECT AFP Assay, ARCHITECT AFP Calibrators and ARCHITECT AFP Controls
Labeling, Approval Order, and Summary of Safety and Effectiveness for Abbott Laboratories ARCHITECT AFP Assay, ARCHITECT AFP Calibrators and ARCHITECT AFP Controls (P120008).
Source: Food and Drug Adminstration (FDA): CDRHNew - December 5, 2012 Category: Medical Equipment Source Type: news
Consumer Information on: Abbott Laboratories ARCHITECT AFP Assay, ARCHITECT AFP Calibrators and ARCHITECT AFP Controls - P120008
The ARCHITECT AFP Assay is an automated laboratory molecular immunoassay test that measures how much alpha-fetoprotein2 (AFP) is in serum or plasma (blood products) or amniotic fluid.
Source: Food and Drug Adminstration (FDA): CDRHNew - December 5, 2012 Category: Medical Equipment Source Type: news
12.06.12 -- First Patient Procedures With truFreeze Spray Cryotherapy System Announced
12/06/12 Medical Design Online Newsletter
Source: Medical Design Online News - December 4, 2012 Category: Medical Equipment Source Type: news
FDA, Private Groups Team Up to Speed Device Approval
(MedPage Today) -- The FDA has announced a new nonprofit private-public partnership aimed at helping medical device companies get their products to market faster.
Source: MedPage Today Cardiovascular - December 4, 2012 Category: Cardiology Source Type: news
First-ever group aims to speed medical devices to market
A public-private consortium that includes the FDA, CMS, and medical-device makers aims to pool its collective expertise to streamline product development and testing.
Source: theHeart.org - December 4, 2012 Category: Cardiology Source Type: news
Baxter to Buy Swedish Firm Gambro in $2.76 Billion Deal
Drug and medical device maker Baxter International plans to buy the privately held Swedish company Gambro AB for about $2.76 billion to broaden its dialysis product portfolio.
Source: Arkansas Business - Health Care - December 4, 2012 Category: American Health Source Type: news
Federal Register: Request for Notification From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on the Device Good Manufacturing Practice..
The FDA is requesting that any industry organization interested in participating in the selection of nonvoting industry representatives to serve on the Device Good Manufacturing Practice Advisory Committee (DGMPAC) in the Center for Devices and...
Source: Food and Drug Adminstration (FDA): CDRHNew - December 4, 2012 Category: Medical Equipment Source Type: news
CDRH 2013 Strategic Priorities
CDRH's 2013 Strategic Priorities continue and expand upon the work we first started three years ago to reset the direction of the Center towards smart regulation - protecting public health by assuring that devices that enter and remain on the market...
Source: Food and Drug Adminstration (FDA): CDRHNew - December 4, 2012 Category: Medical Equipment Source Type: news
Angel Medical Systems Partners With Flextronics To Achieve 600th Patient Implant Of Cardiac Medical Device
Angel Medical Systems, an innovator in today's cardiac medical device arena, recently celebrated the implant of the 600th patient with its AngelMed Guardian system
Source: Medical Design Online News - December 3, 2012 Category: Medical Equipment Source Type: news
First Patient Enrolled In The Boston Scientific Multicenter Study Of The SYNERGY™ Coronary Stent System Featuring A Bioabsorbable Polymer Coating
The first patient has been enrolled in the Boston Scientific Corporation (NYSE: BSX) EVOLVE II clinical trial, which is designed to further assess the safety and effectiveness of the SYNERGY Stent System and support U.S. Food and Drug Administration and Japanese regulatory approvals for the treatment of atherosclerotic coronary lesions
Source: Medical Design Online News - December 3, 2012 Category: Medical Equipment Source Type: news
CareFusion And Cerner Implement Integrated Solution To Help Improve Patient Safety, Streamline IV Medication Management
CareFusion Corp. (NYSE: CFN), a leading, global medical technology company, today announced the implementation of a solution that connectsits Alaris® System smart infusion pumps with the Cerner Millennium®1 electronic health record (EHR) at Children's Hospitals and Clinics of Minnesota
Source: Medical Design Online News - December 3, 2012 Category: Medical Equipment Source Type: news
Nonin Medical, Inc. Announces Publication Of Two Studies That Demonstrate Effectiveness Of Its EQUANOX™ Model 7600 Regional Oximeter System
Nonin Medical, Inc. announced today the publication of two separate studies that demonstrate the clinical efficacy of the company's EQUANOX™ Model 7600 Cerebral and Somatic Oximetry System in adult and pediatric patients
Source: Medical Design Online News - December 3, 2012 Category: Medical Equipment Source Type: news
The Christ Hospital On Cutting Edge Of New Stent Technology; Implants Investigational New Device
Clinical scientists at The Christ Hospital's Lindner Research Center are leading a worldwide study evaluating new breakthrough coronary stent technology that may make stenting easier and safer
Source: Medical Design Online News - December 3, 2012 Category: Medical Equipment Source Type: news
FDA announces public-private partnership to develop regulatory science that will speed patient access to new medical device technologies
The U.S. Food and Drug Administration announced today that it is part of the first public-private partnership to promote medical device regulatory science with a focus on speeding the development, assessment, and review of new medical devices.
Source: Food and Drug Administration - December 3, 2012 Category: American Health Source Type: news
Meeting Materials posted for December 5-6, 2012 Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting
Source: Food and Drug Adminstration (FDA): CDRHNew - December 3, 2012 Category: Medical Equipment Source Type: news
Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Investigational Device Exemptions Reports and Records
The FDA is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Source: Food and Drug Adminstration (FDA): CDRHNew - December 3, 2012 Category: Medical Equipment Source Type: news
Toshiba MR System Expands Clinical Capabilities, Improves Patient Comfort At Fairview Hospital
Fairview Southdale Hospital in Edina, Minn., improved its advanced imaging capabilities and patient comfort by installing the first 16-channel Vantage TitanTM 1.5T scalable system from Toshiba America Medical Systems, Inc. Fairview will use the system for all general MR exams, as well as breast and cardiac imaging, and expand its capabilities by offering prostate imaging to patients
Source: Medical Design Online News - December 2, 2012 Category: Medical Equipment Source Type: news
Gore Receives CE Mark For New Large Diameter GORE EXCLUDER AAA Endoprosthesis
W. L. Gore & Associates, Inc. (Gore) has received CE Mark (Conformité Européenne) for the new large diameter 35 mm trunk-ipsilateral leg and 36 mm aortic extender components of the GORE EXCLUDER AAA Endoprosthesis
Source: Medical Design Online News - December 2, 2012 Category: Medical Equipment Source Type: news
Zilver® PTX® Drug-Eluting Peripheral Stent
The Zilver® PTX Drug-Eluting Peripheral Stent (Zilver® PTX Stent) is a self-expanding, small metal, mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be implanted in an artery in the thigh (femoropopliteal2 artery). (Approved: 11/14/2012)
Source: Medical Device Approvals - November 30, 2012 Category: Medical Equipment Source Type: news
Summary Information for: Zilver® PTX® Drug-Eluting Peripheral Stent
Labeling, Approval Order, and Summary of Safety and Effectiveness for Zilver® PTX® Drug-Eluting Peripheral Stent (P100022).
Source: Food and Drug Adminstration (FDA): CDRHNew - November 30, 2012 Category: Medical Equipment Source Type: news
Consumer Information on: Zilver® PTX® Drug-Eluting Peripheral Stent - P100022
The Zilver® PTX Drug-Eluting Peripheral Stent (Zilver® PTX Stent) is a self-expanding, small metal, mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be implanted in an artery in the thigh (femoropopliteal2 artery).
Source: Food and Drug Adminstration (FDA): CDRHNew - November 30, 2012 Category: Medical Equipment Source Type: news
PMA Final Decisions for September 2012
These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for September 2012.
Source: Food and Drug Adminstration (FDA): CDRHNew - November 30, 2012 Category: Medical Equipment Source Type: news
Class I Medical Device Recall: Mindray A3 and A5 Anesthesia Delivery System
Reason for Recall: The affected anesthesia delivery systems may have a gasket leak which could cause an interruption of or inadequate patient anesthesia and ventilation, temporary or permanent patient injury, or death. Facilities should consider having ba
Source: Food and Drug Adminstration (FDA): CDRHNew - November 30, 2012 Category: Medical Equipment Source Type: news
NeuroMetrix Completes 510(k) Clearance Process For SENSUS Pain Management System
NeuroMetrix, Inc., a medical device company focused on the diagnosis and treatment of the neurological complications of diabetes, reported that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the disposable electrode that is used in conjunction with its SENSUS device
Source: Medical Design Online News - November 29, 2012 Category: Medical Equipment Source Type: news
SGS Invites Medical Device Executives to a 45 Minute Free Webinar...
Changing regulations require change(PRWeb November 28, 2012)Read the full story at http://www.prweb.com/releases/2012/11/prweb10178990.htm
Source: PRWeb: Medical Pharmaceuticals - November 29, 2012 Category: Pharmaceuticals Source Type: news
Federal Register: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory..
Source: Food and Drug Adminstration (FDA): CDRHNew - November 29, 2012 Category: Medical Equipment Source Type: news
Meeting Announcement - April 5, 2013: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee
Source: Food and Drug Adminstration (FDA): CDRHNew - November 29, 2012 Category: Medical Equipment Source Type: news
Letter to Industry Announcing the Launch of the CDRH Export Certification and Tracking System (CECATS)
Today the FDA?s Center for Devices and Radiological Health (CDRH) launched the first phase of a new, Internet-based system for submitting and processing export document requests. The CDRH Export Certification and Tracking System (CECATS) will allow...
Source: Food and Drug Adminstration (FDA): CDRHNew - November 29, 2012 Category: Medical Equipment Source Type: news
CDRH Export Certification Application and Tracking System (CECATS) Frequently Asked Questions
What is CECATS? CECATS is CDRH?s web-based application for accepting requests, reviewing, processing, managing, and administering export certificates, simple notifications, and export permit letters. In the first phase, which begins in November 2012...
Source: Food and Drug Adminstration (FDA): CDRHNew - November 29, 2012 Category: Medical Equipment Source Type: news
FDA clears AFrame’s MobileCare Monitor as Class II device
AFrame Digital, a Reston, Va.-based maker of telemonitoring technology, has received 510(k) clearance from the FDA to sell its MobileCare Monitor as a Class II medical device in the US. The company has had less-stringent Class I approval for its flagship monitoring product since 2009.
MobileCare Monitor is a wristwatch-like device that offers continuous, real-time monitoring [...]
Source: mobihealthnews - November 28, 2012 Category: Information Technology Authors: Neil Versel Tags: Uncategorized AFrame Digital aging in place chronic disease management FDA FDA 510(k) mobile health regulations MobileCare telemonitoring Source Type: news
Samsung forms medical equipment division
Samsung Electronics America announced the creation of Samsung Health & (more)
Source: AuntMinnie.com Headlines - November 28, 2012 Category: Radiology Source Type: news
Smith & Nephew – non-invasive
The UK medical devices group’s purchase of Healthpoint addresses a key weakness and expands its presence in the crucial US market
Source: FT.com - Drugs and Healthcare - November 28, 2012 Category: Pharmaceuticals Source Type: news
St. Jude Medical Announces CE Mark Approval Of Assura Family Of Implantable Defibrillators Including New Quadripolar Device
St. Jude Medical, Inc., a global medical device company, today announced European CE Mark approval of the Assura portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds)
Source: Medical Design Online News - November 28, 2012 Category: Medical Equipment Source Type: news
Neusoft gets FDA OK for NeuViz 64
Chinese medical equipment manufacturer Neusoft Medical Systems has received (more)
Source: AuntMinnie.com Headlines - November 27, 2012 Category: Radiology Source Type: news
