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 25.
FDA Clears First Ever Bi-directionally Retrievable Vena Cava Filter From Crux Biomedical
Crux Biomedical announced it has received U.S. Food and Drug Administration (FDA) clearance for its novel inferior vena cava filter (VCF) with bi-directional retrieval. VCF are designed to trap blood clots that can lead to potentially fatal pulmonary embolisms among patients at risk
Source: Medical Design Online News - July 18, 2012 Category: Medical Equipment Source Type: news
Guided Therapeutics Notified Of CE Mark Approval For LuViva Advanced Cervical Scan
Guided Therapeutics, Inc. today announced that it has received notification that CE Mark approval has been granted for LuViva Advanced Cervical Scan, a non-invasive device used to detect cervical disease that leads to cancer, instantly and at the point of care
Source: Medical Design Online News - July 18, 2012 Category: Medical Equipment Source Type: news
CellAegis Devices Receives CE Mark For autoRIC Device In The European Union
CellAegis Devices, Inc., announced today that it has received a CE Mark for the Company’s autoRIC Device, which for the first time allows simple, consistent, reliable and cost-effective automation of remote ischemic conditioning (RIC) at the point of care
Source: Medical Design Online News - July 18, 2012 Category: Medical Equipment Source Type: news
Transcript posted for June 13, 2012: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting
Source: Food and Drug Adminstration (FDA): CDRHNew - July 18, 2012 Category: Medical Equipment Source Type: news
September 21, 2012: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
Source: Food and Drug Adminstration (FDA): CDRHNew - July 18, 2012 Category: Medical Equipment Source Type: news
Federal Register: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
On September 21, 2012, the committee will discuss and make recommendations regarding the classification of posterior cervical screws, including pedicle and lateral mass screws. Cervical pedicle and lateral mass screws are components of rigid, posterior...
Source: Food and Drug Adminstration (FDA): CDRHNew - July 18, 2012 Category: Medical Equipment Source Type: news
07.19.12 -- Biliary Self-Expanding Stent System Receives FDA 510(k) SE Clearance
07/19/12 Medical Design Online Newsletter
Source: Medical Design Online Newsletters - July 17, 2012 Category: Medical Equipment Source Type: news
3272 CR DC Motor
MICROMO presents the 3272 CR DC Motor from FAULHABER. Setting new standards, the 3272 CR offers graphite commutation and premium materials produced with cutting-edge process technologies.
Source: Medical Design Online Products - July 17, 2012 Category: Medical Equipment Source Type: news
3863 CR DC Micro Motor
MICROMO presents the 3863 CR DC Micro Motor from FAULHABER. The 3863-CR has ZHN48 magnet material for benchmark torque performance of 150 mNm at 8,000 RPM. The new DC Motor is available in 12, 18, 24, 36, 48 volts and can be equipped with a three channel encoder (also available in a Linedriver design) as well as combined with a wide range of precision gearheads.
Source: Medical Design Online Products - July 17, 2012 Category: Medical Equipment Source Type: news
QUICKSHAFT
The innovative design with a 3-phase self-supporting coil and non-magnetic steel housing offers outstanding high-resolution performance. The absence of residual static force and the excellent relationship between the linear force and current make these motors ideal for use in micro-positioning applications.
Source: Medical Design Online Products - July 17, 2012 Category: Medical Equipment Source Type: news
Inquiry Sought of Extensive F.D.A. Surveillance
The secretary of health and human services, Kathleen Sebelius, is urged to find out whether the program violated federal employee protections and whistle-blower laws.
Source: NYT - July 17, 2012 Category: American Health Authors: By ERIC LICHTBLAU Tags: Food and Drug Administration Whistle-Blowers Medical Devices Sebelius, Kathleen Van Hollen, Christopher Jr Radiation Cancer Source Type: news
'TOWIE lifestyle' link to type 2 diabetes
Conclusion
In this cross-sectional study, women with higher levels of phthalate breakdown products in their urine were more likely to report having diabetes. However, this study has many limitations, restricting the applicability of this finding. These include:
The study design
Cross-sectional studies only look at one point in time and, therefore, can only find associations. As both phthalates and diabetes were assessed at the same time, the order of events also cannot be determined. The researchers point out that due to the cross-sectional study design, reverse causation cannot be ruled out. That is, that people with dia...
Source: NHS News Feed - July 17, 2012 Category: Consumer Health News Tags: Diabetes Lifestyle/exercise Source Type: news
Terumo Completes U.S. Patient Enrollment In The OSPREY Trial To Evaluate The MISAGO Self-Expanding Stent
Terumo Interventional Systems, a strategic business unit of Terumo Medical Corporation, a U.S. subsidiary of Terumo Corporation, today announced the completion of U.S. patient enrollment in the Occlusive/Stenotic Peripheral Artery REvascularization StudY (OSPREY) designed to evaluate the safety and effectiveness of the MISAGO™ Self-expanding Stent System
Source: Medical Design Online News - July 16, 2012 Category: Medical Equipment Source Type: news
TriReme Receives FDA Approval For Expanded Matrix Of Novel Glider™ PTCA Balloon Catheter
TriReme Medical, Inc. (TMI) announced today that it has received FDA clearance for an expanded matrix of sizes for its unique Glider™ PTCA balloon catheter. Glider™ is now approved for the treatment of lesions in the coronary vasculature in balloon diameters from 1.5 – 3.5mm and in lengths from 4mm to 20mm
Source: Medical Design Online News - July 16, 2012 Category: Medical Equipment Source Type: news
Largest Public Hospital In Sydney Delivers First Treatment In Australia Using Advanced TrueBeam Radiotherapy And Radiosurgery Device
An 82-year-old prostate cancer patient has become the first person in Australia to be treated using the fast and precise TrueBeam™ radiotherapy treatment system from Varian Medical Systems (NYSE: VAR). In a treatment carried out at the Crown Princess Mary Cancer Centre Westmead in Sydney, the patient received intensity modulated radiotherapy using the newly-installed system
Source: Medical Design Online News - July 16, 2012 Category: Medical Equipment Source Type: news
South Africa halts distribution of 'blacklisted' HIV testing kit
THE DISTRIBUTION and use of 4.5 million HIV testing kits in South Africa has been halted by the government after it emerged the medical equipment was recently blacklisted by the UN World Health Organisation.
Source: The Irish Times - Health - July 16, 2012 Category: Consumer Health News Source Type: news
FDA updates early-feedback program for devices in development
Looking to make good on previous promises to foster rather than hinder innovation in the medical device industry, the FDA has released draft guidance outlining its updated pre-Investigational Device Exemption (IDE) program. According to an item announcing the guidance in the July 13 Federal Register, the updating includes giving IDE a simpler name: the Pre-Submission Program.
Source: Health Imaging News - July 16, 2012 Category: Radiology Tags: Latest News Source Type: news
FDA Monitors Scientists' Critical Emails
The Food and Drug Administration has been secretly monitoring the emails of its scientists, who had expressed criticism of the agency's review process for approving medical devices. The New York Times reported the FDA captured thousands of private communications involving the scientists and members of Congress, their lawyers and even President Obama. Steve Inskeep talks with Times reporter Scott Shane, who co-reported the story.» E-Mail This » Add to Del.icio.us
Source: NPR Health and Science - July 16, 2012 Category: Consumer Health News Source Type: news
therascreen® KRAS RGQ PCR Kit
The therascreen® KRAS RGQ PCR Kit is a genetic test designed to detect the presence of seven mutations in the K-ras gene in colorectal cancer cells. In normal tissue, the K-ras protein transmits signals in cells to regulate cell growth and cell death. (Approved: 7/6/2012)
Source: Medical Device Approvals - July 16, 2012 Category: Medical Equipment Source Type: news
Healon® EndoCoat Ophthalmic Viscosurgical Device (OVD)
is made of sodium hyaluronate, a clear, thick liquid. It is injected from a syringe into the patient?s eye to protect and coat the eye?s tissues during surgery. (Approved: 7/2/2012)
Source: Medical Device Approvals - July 16, 2012 Category: Medical Equipment Source Type: news
Glaukos iStent® Trabecular Micro-Bypass Stent (Models: GTS-100R, GTS-100L) and Inserter (GTS-100i)
The iStent® is a tiny L-shaped device made of titanium. It is 1 millimeter long and 0.33 millimeters high and is pre-loaded in the inserter of the iStent® for implantation inside the eye. (Approved: 6/25/2012)
Source: Medical Device Approvals - July 16, 2012 Category: Medical Equipment Source Type: news
Summary Information for: therascreen® KRAS RGQ PCR Kit
Labeling, Approval Order, and Summary of Safety and Effectiveness for therascreen® KRAS RGQ PCR Kit (P110030).
Source: Food and Drug Adminstration (FDA): CDRHNew - July 16, 2012 Category: Medical Equipment Source Type: news
Consumer Information on: therascreen® KRAS RGQ PCR Kit - P110030
The therascreen® KRAS RGQ PCR Kit is a genetic test designed to detect the presence of seven mutations in the K-ras gene in colorectal cancer cells. In normal tissue, the K-ras protein transmits signals in cells to regulate cell growth and cell death.
Source: Food and Drug Adminstration (FDA): CDRHNew - July 16, 2012 Category: Medical Equipment Source Type: news
Consumer Information on: Healon® EndoCoat Ophthalmic Viscosurgical Device (OVD) - P110007
Healon® EndoCoat Ophthalmic Viscosurgical Device (OVD) is made of sodium hyaluronate, a clear, thick liquid. It is injected from a syringe into the patient?s eye to protect and coat the eye?s tissues during surgery.
Source: Food and Drug Adminstration (FDA): CDRHNew - July 16, 2012 Category: Medical Equipment Source Type: news
Summary Information for: Healon® EndoCoat Ophthalmic Viscosurgical Device (OVD)
Labeling, Approval Order, and Summary of Safety and Effectiveness for Healon® EndoCoat Ophthalmic Viscosurgical Device (OVD) (P110007).
Source: Food and Drug Adminstration (FDA): CDRHNew - July 16, 2012 Category: Medical Equipment Source Type: news
Consumer Information on: Glaukos iStent® Trabecular Micro-Bypass Stent (Models: GTS-100R, GTS-100L) and Inserter (GTS-100i) - P080030
The iStent® is a tiny L-shaped device made of titanium. It is 1 millimeter long and 0.33 millimeters high and is pre-loaded in the inserter of the iStent® for implantation inside the eye.
Source: Food and Drug Adminstration (FDA): CDRHNew - July 16, 2012 Category: Medical Equipment Source Type: news
Summary Information for: Glaukos iStent® Trabecular Micro-Bypass Stent (Models: GTS-100R, GTS-100L) and Inserter (GTS-100i)
Labeling, Approval Order, and Summary of Safety and Effectiveness for Glaukos iStent® Trabecular Micro-Bypass Stent (Models: GTS-100R, GTS-100L) and Inserter (GTS-100i) (P080030).
Source: Food and Drug Adminstration (FDA): CDRHNew - July 16, 2012 Category: Medical Equipment Source Type: news
International Products Corporation Offers Re-Sealable P-80 Tubes In New Size
Re-sealable plastic tubes of P-80 Temporary Rubber Assembly Lubricants are available from International Products Corporation (IPC) in the new 10ml size and will be sold in cases of 100. The new tubes feature heat-sealed tips which will prevent leaks during shipping and keep material fresh until it is used.
Source: Medical Design Online News - July 15, 2012 Category: Medical Equipment Source Type: news
FDA Looks At Release Of Files on Devices
The FDA is investigating how a document-management company inadvertently made public some 75,000 pages of confidential agency files about the approval of medical devices.
Source: WSJ.com: Health - July 15, 2012 Category: Pharmaceuticals Tags: PAID Source Type: news
Breakthrough Device To Treat Neurological Disorders
Operating theaters may be using pioneering exploring technology in form of an ultraviolet camera in the future. The system, developed by neurosurgeons and researchers from the Cedars-Sinai Medical Center and the Maxine Dunitz Neurosurgical Institute could, if it works, give surgeons a real-time view of changes that are invisible to the naked eye when focused on brain tissue that are not even visible with magnification of current medical imaging technologies...
Source: Health News from Medical News Today - July 13, 2012 Category: Consumer Health News Tags: Medical Devices / Diagnostics Source Type: news
B.Braun gets options to buy Rhoen stake: sources
FRANKFURT (Reuters) - B.Braun, an unlisted maker of medical devices, has acquired options to buy a stake of German hospital operator Rhoen-Klinikum, two people familiar with the matter said, further dimming Fresenius SE's chances of taking control of Rhoen.
Source: Reuters: Health - July 13, 2012 Category: Consumer Health News Tags: healthNews Source Type: news
Keyhole Surgery Demands Operating Room Upgrades
Minimally invasive surgery (MIS) is on the rise, as waiting lists lengthen and patients call for fast results, says a new report by healthcare experts GlobalData. The new report* shows that advanced surgery procedures promise patients smaller scars and faster healing, but demand state of the art technology for surgeons to perform their work, which in turn demand high levels of investment. Minimally invasive procedures have witnessed rapid growth globally, and are expected to continue to grow in the future...
Source: Health News from Medical News Today - July 13, 2012 Category: Consumer Health News Tags: Medical Devices / Diagnostics Source Type: news
Federal Register: Regulatory Science Considerations for Medical Countermeasure Radiation Biodosimetry Devices
The purpose of the public meeting is to obtain input from academia, Government, industry, and other stakeholders on the clinical application and scientific and technological challenges for performance validation of radiation biodosimetry devices.
Source: Food and Drug Adminstration (FDA): CDRHNew - July 13, 2012 Category: Medical Equipment Source Type: news
Public Meeting - Regulatory Science Considerations for Medical Countermeasure Radiation Biodosimetry Devices, September 27-28, 2012
The purpose of this meeting is to obtain input from academia, Government, industry and other stakeholders on the clinical application and scientific and technological challenges for performance validation of radiation biodosimetry devices.
Source: Food and Drug Adminstration (FDA): CDRHNew - July 13, 2012 Category: Medical Equipment Source Type: news
PMA Final Decisions for May 2012
These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for May 2012.
Source: Food and Drug Adminstration (FDA): CDRHNew - July 13, 2012 Category: Medical Equipment Source Type: news
Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices: The Pre-Submission Program and Meetings With FDA Staff; Availability
The purpose of this guidance is to describe the Pre-Submission program (formerly the pre-IDE program) for medical devices reviewed in CDRH and CBER. In addition, the guidance provides recommendations regarding information that should be included in a...
Source: Food and Drug Adminstration (FDA): CDRHNew - July 13, 2012 Category: Medical Equipment Source Type: news
Federal Register: Agency Information Collection Activities; Submission for OMB Review; Comment Request: Guidance for Industry and Food and Drug Administration Staff; Class II SCGD; Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation...
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 - July 13, 2012 Category: Medical Equipment Source Type: news
User Fees for Medical Devices: Third Time Lucky?
President Obama just signed the Food and Drug Administration Safety and Innovation Act. The Act includes the third authorisation of user fees, paid by the medical-device industry to the FDA, so that the FDA can improve its performance in licensing new medical devices. The FDA's process has long been unsatisfactory. This is why the medical-device ...
Source: Forbes.com Health News - July 12, 2012 Category: Consumer Health News Source Type: news
FDA to guide device makers on marketing application
(Reuters) - The Food and Drug Administration plans to provide medical device makers feedback before they apply for marketing approval to help companies identify regulatory requirements early in the device development process.
Source: Reuters: Health - July 12, 2012 Category: Consumer Health News Tags: healthNews Source Type: news
FDA outlines plans to provide earlier feedback on device product submissions
The U.S. Food and Drug Administration today issued a draft guidance that outlines the agency’s recommendations and procedures for medical device manufacturers and researchers who want early feedback and advice before submitting a product- or research-specific application.
Source: Food and Drug Administration - July 12, 2012 Category: American Health Source Type: news
Insight: As lawsuits climb, J&J may have new hip trauma
CHICAGO (Reuters) - Johnson & Johnson faces a potentially more damaging and costly sequel to the $3 billion recall of its ASR all-metal artificial hips two years ago, one of the most expensive medical device failures in U.S. history.
Source: Reuters: Health - July 12, 2012 Category: Consumer Health News Tags: healthNews Source Type: news
Evaluation of Automatic Class III Designation (De Novo) Summaries (K082776 added)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 12, 2012 Category: Medical Equipment Source Type: news
Draft Guidance for Industry and FDA Staff Medical Devices: The Pre-Submission Program and Meetings with FDA Staff
Since its establishment in 1995, the pre-IDE program has been a successful resource for both medical device applicants and the FDA. Originally, this program was designed to provide applicants a mechanism to obtain FDA feedback on future Investigational...
Source: Food and Drug Adminstration (FDA): CDRHNew - July 12, 2012 Category: Medical Equipment Source Type: news
CDRH Learn (New Module - Unique Device Identification (UDI) System)
New CDRH Learn course module about FDA's Unique Device Identification System proposed regulation.
Source: Food and Drug Adminstration (FDA): CDRHNew - July 12, 2012 Category: Medical Equipment Source Type: news
Global Vision Releases Docu-Proof™ Enterprise 2.0 With New Table Inspection Capabilities
Global Vision adds new table inspection capabilities with the release of Docu-Proof™ Enterprise 2.0 documentation software.
Source: Medical Design Online News - July 11, 2012 Category: Medical Equipment Source Type: news
BSD Medical Expands MicroThermX Ablation Market Opportunity By Introducing Short Tip SynchroWave Antenna
BSD Medical Corporation (the “Company” or “BSD”) announced recently that the Company has significantly expanded the MicroThermX Microwave Ablation System (MicroThermX) market opportunity by introducing a new SynchroWave short tip (ST) antenna
Source: Medical Design Online News - July 11, 2012 Category: Medical Equipment Source Type: news
COBAS® AmpliPrep/COBAS® TaqMan® CMV Test
The COBAS® AmpliPrep/COBAS® TaqMan® CMV Test is a laboratory test used to measure the amount of Cytomegalovirus (CMV) DNA in a patient's plasma. Viral DNA is the genetic material from CMV. (Approved: 7/5/2012)
Source: Medical Device Approvals - July 11, 2012 Category: Medical Equipment Source Type: news
Class I Medical Device Recall: Maquet Medical Systems USA, FLOW-i Anesthesia System (software)
Reason for Recall: A technical alarm may be generated on the FLOW-i system when using the Manual/Automatic (MAN/AUTO) switch to change ventilation modes from manual to automatic or from automatic to manual if the switch is not fully engaged in the...
Source: Food and Drug Adminstration (FDA): CDRHNew - July 11, 2012 Category: Medical Equipment Source Type: news
