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This page shows you the most recent publications within this specialty of the MedWorm directory. This is page number 6.

Covidien Announces Five-Year Results From The ClosureFast Long-Term European Multi-Center Study In Patients With Lower Limb Venous Disease
Covidien, a leading global provider of healthcare products, today announced the five-year results of the ClosureFast Long-Term European Multi-Center Study in patients with Chronic Venous Insufficiency (CVI)
Source: Medical Design Online News - December 20, 2012 Category: Medical Equipment Source Type: news

New review finds drug, device study results affected by funding source
Lisa Bero, PhD Image: Cindy Chew An updated and expanded review of clinical research papers on drugs and medical devices finds that industry-sponsored studies are more likely to lead to favorable results, including reports of greater benefits and fewer harmful side effects. The analysis of 48 published studies, covering conditions ranging from heart disease to psychiatric illnesses, also found that industry-funded papers were more likely to report conclusions that were inconsistent with their own results sections. The article, “Industry sponsorship and research outcome,” is co-authored by Lisa Bero, PhD, a fa...
Source: UCSF School of Pharmacy News - December 19, 2012 Category: Universities & Medical Training Source Type: news

US Trauma Device Market To See Steady Growth To $3.9B By 2017
According to Millennium Research Group (MRG), the global authority on medical technology market intelligence, the US trauma device market will grow at a steady pace through 2017
Source: Medical Design Online News - December 19, 2012 Category: Medical Equipment Source Type: news

Minimally Invasive Hybrid Ablation Procedure Demonstrates Significant Benefits For The Treatment Of Atrial Fibrillation
A physician study published in the Polish Journal of Cardiology showed a minimally invasive hybrid ablation procedure known as the Convergent Procedure, combining the expertise and technologies of both electrophysiologists and surgeons, helped persistent patients with atrial fibrillation maintain normal sinus rhythm without medication
Source: Medical Design Online News - December 19, 2012 Category: Medical Equipment Source Type: news

Federal Register: Comprehensive Assessment of the Process for the Review of Device Submissions; Request for Comments
The FDA is announcing an opportunity for public comment on the statement of work for an assessment of the process for the review of medical device submissions. The assessment is part of the FDA performance commitments relating to the Medical Device User..
Source: Food and Drug Adminstration (FDA): CDRHNew - December 19, 2012 Category: Medical Equipment Source Type: news

Ascendx Spine Receives FDA 510(k) Clearance For Its Ascendx VCF Repair System Designed For The Treatment Of Vertebral Compression Fractures (VCFs)
Ascendx Spine, Inc., (www.ascendxspine.com) has received FDA 510(k) clearance for its Ascendx VCF Repair System. Previously, the Company has received FDA clearance for its Ascendx Acu-Cut Vertebral Augmentation System. Both products, which are used to treat vertebral compression fractures (VCF), are also approved for marketing in Europe
Source: Medical Design Online News - December 18, 2012 Category: Medical Equipment Source Type: news

Avinger Receives FDA Clearance For Ocelot | PIXL
Avinger Inc., a medical device manufacturer of innovative, multi-functional imaging catheters for crossing chronic total occlusions (CTOs) in patients with Peripheral Artery Disease (PAD), has received FDA clearance to market Ocelot | PIXL in the United States
Source: Medical Design Online News - December 18, 2012 Category: Medical Equipment Source Type: news

UK's National Institute For Health Research (NIHR) Highlights Miracor's PICSO System As A Key Emerging Health Intervention
Miracor Medical Systems GmbH announced today that its PICSO System is the focus of a December 2012 report by the UK’s National Institute for Health Research (NIHR) that cites PICSO as a key emerging health intervention whose potential impact “…to current treatments such as PCI (percutaneous coronary intervention, or angioplasty) could improve patient outcomes by reducing the damage to, or scarring of, the heart muscle”
Source: Medical Design Online News - December 18, 2012 Category: Medical Equipment Source Type: news

CardiacAssist Receives FDA IDE Approval For Use Of The TandemHeart System In Pivotal Clinical Study
CardiacAssist, Inc., a privately-held medical technology company headquartered in Pittsburgh, Pennsylvania, announced today that it received Investigational Device Exemption (IDE) approval from the Food & Drug Administration (FDA) for a pivotal clinical study of the TandemHeart circulatory support system
Source: Medical Design Online News - December 18, 2012 Category: Medical Equipment Source Type: news

St. Jude Medical Enrolls First Patient In ILUMIEN I Study To Develop Guidance For Stent Optimization
St. Jude Medical, Inc., a global medical device company, today announced the first patient enrollment in its ILUMIEN I clinical study
Source: Medical Design Online News - December 18, 2012 Category: Medical Equipment Source Type: news

Improved GORE DrySeal Sheath With Hydrophilic Coating Allows For Smooth And Minimally Invasive Endovascular Repair
W. L. Gore & Associates (Gore) today introduced GORE DrySeal Sheath with hydrophilic coating, allowing for easier insertion and removal to and from blood vessels during endovascular repair procedures
Source: Medical Design Online News - December 18, 2012 Category: Medical Equipment Source Type: news

MITA survey warns of medical device tax impact
The medical device excise tax set to go into effect on January 1, 2013, in (more)
Source: AuntMinnie.com Headlines - December 18, 2012 Category: Radiology Source Type: news

Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes (added P980016/S376, P980050/S076, P010031/S329)
Source: Food and Drug Adminstration (FDA): CDRHNew - December 18, 2012 Category: Medical Equipment Source Type: news

CDRH Reorganization: Management Directory by Organization
This information is current as of December 17, 2012.
Source: Food and Drug Adminstration (FDA): CDRHNew - December 18, 2012 Category: Medical Equipment Source Type: news

CDRH Reorganization: Office of In Vitro Diagnostics and Radiological Health
The Office of In Vitro Diagnostics and Radiological Health (OIR): regulates in-home and laboratory diagnostic tests (in vitro diagnostic devices, or IVDs); regulates radiological medical devices; regulates radiation-emitting non-medical products; and...
Source: Food and Drug Adminstration (FDA): CDRHNew - December 18, 2012 Category: Medical Equipment Source Type: news

CDRH Reorganization: Office of Device Evaluation
ODE is responsible for the program areas through which medical devices are evaluated or cleared for clinical trials and marketing. This page provides summary information about the major programs administered by ODE and includes a brief description of...
Source: Food and Drug Adminstration (FDA): CDRHNew - December 18, 2012 Category: Medical Equipment Source Type: news

CDRH Reorganization: Office of Communication, Education, and Radiation Programs
We are the Office of Communication, Education, and Radiation Programs. Our mission is to collaboratively support CDRH and the FDA in assuring the safety and effectiveness of medical devices and radiation-emitting electronic products. We accomplish this...
Source: Food and Drug Adminstration (FDA): CDRHNew - December 18, 2012 Category: Medical Equipment Source Type: news

This information is current as of December 17, 2012.
Source: Food and Drug Adminstration (FDA): CDRHNew - December 18, 2012 Category: Medical Equipment Source Type: news

First Patients Treated With The CyberKnife® Robotic Radiosurgery System In Venezuela
Accuray Incorporated (Nasdaq: ARAY) announced today that doctors at Hospital Dr Domingo Luciani in Venezuela are now treating patients with the CyberKnife® Robotic Radiosurgery System, the first and only robotic radiosurgery system
Source: Medical Design Online News - December 17, 2012 Category: Medical Equipment Source Type: news

Andrew Technologies Receives FDA 510 (k) Clearance For Commercial Version Of HydraSolve™ Lipoplasty System
Andrew Technologies, LLC received FDA 510 (k) clearance for the commercially manufactured version of the HydraSolve™ Lipoplasty System, having successfully completed design verification and validation of that device vs. the previously cleared prototype device
Source: Medical Design Online News - December 17, 2012 Category: Medical Equipment Source Type: news

Toshiba's Aquilion ONE Enables Faster, Lower Dose Exams At Orlando Health
To lower CT radiation dose for cardiac exams and to improve image quality, the Orlando Health Heart Institute, in Orlando, Fla., utilizes Toshiba America Medical Systems, Inc.’s AquilionTM ONE CT system with AIDR 3D
Source: Medical Design Online News - December 17, 2012 Category: Medical Equipment Source Type: news

Paralyzed Woman's Mind Controls Robotic Arm
A paralyzed woman has been able to control a robotic prosthetic hand using her thoughts. This woman, struggling with tetraplegia, has obtained a level of movement and control with the hand comparable to people without any impairment. The research came from a team of experts at the University of Pittsburgh and was published Online First in The Lancet. Until now, a patient with this type of prosthesis has never experienced control and movement to this extent...
Source: Health News from Medical News Today - December 17, 2012 Category: Consumer Health News Tags: Medical Devices / Diagnostics Source Type: news

Masimo offers iPhone-enabled pulse ox to climbers, pilots
Masimo, a medical device maker founded in 1989, has released a commercially-available iOS-enabled pulse oximeter called the iSpO2. Pulse oximeters, which have long been a core product of Masimo, measure blood oxygen level and pulse rate by shining light through the fingertip and measuring the absorption of different wavelengths. The product is not FDA cleared and [...]
Source: mobihealthnews - December 17, 2012 Category: Information Technology Authors: Jonah Comstock Tags: Uncategorized Azumio Azumio Instant Heart Rate Masimo mobile pulse oximeter Nonin Nonin Pulse Oximeter pulse oximetry Tinke Zensorium Source Type: news

Obama firm on medical device tax
President Barack Obama rejected the idea of delaying the implementation of a 2.3 percent medical device tax slated to go into effect on Jan. 1, 2013 as part of the Affordable Care Act. The president said medical device companies would make up for the lost revenue because the ACA will bring more healthcare consumers into the marketplace. read more
Source: Healthcare IT News - December 17, 2012 Category: Information Technology Authors: Rene Letourneau Tags: Online Only Barack Obama CBS News Frank Vascellaro Minnesota Mobile/Wireless Policy and Legislation Source Type: news

Micro-PMT
Hamamatsu’s new and innovative photodetector features the characteristics of a conventional PMT in an ultracompact package. The µPMT (micro-PMT) allows device manufacturers to build high-performance portable devices thanks to the detector’s compact size, high sensitivity, and robustness. In addition, the µPMT is easily mass produced and more affordable than conventional PMTs in large quantities.
Source: Medical Design Online Products - December 17, 2012 Category: Medical Equipment Source Type: news

Gambia: Rotary Club of Faraja, Partners Boost the Health Sector
[Daily Observer]The Rotary Club of Fajara in partnership with a Swiss couple, Dr. Theo Keller and his wife Mathilder Keller, on Thursday, November 22nd, 2012 boosted the country's health sector with a major donation of medical equipment worth US$35, 000 to the Royal Victoria Teaching Hospital (RVTH) in Banjul, and the Bansang Hospital in the Central River Region (CRR).
Source: AllAfrica News: Health and Medicine - December 17, 2012 Category: African Health Source Type: news

sCMOS Cameras for OEM
These new OEM cameras from Hamamatsu feature an advanced scientific CMOS (sCMOS) image sensor capable of high resolution, fast frame rates, and low noise simultaneously. With their small size, board-level design, and simple, low-cost integration, these OEM cameras are ideal for imaging in life science, failure analysis, and semiconductor inspection.
Source: Medical Design Online Products - December 17, 2012 Category: Medical Equipment Source Type: news

Corporate Whistle Blower Center Now Urges Medical Industry Insiders to...
The Corporate Whistle Blower Center (http://CorporateWhistleBlowerCenter.Com) is urging all medical device insiders, drug maker insiders, or...(PRWeb December 17, 2012)Read the full story at http://www.prweb.com/releases/2012/12/prweb10217889.htm
Source: PRWeb: Medical Pharmaceuticals - December 17, 2012 Category: Pharmaceuticals Source Type: news

NuVasive, Inc.: NuVasive(R) Receives Regulatory Shonin Approval to Broaden Offering in Japan
SAN DIEGO, CA (MARKET WIRE) NuVasive, Inc. (NASDAQ: NUVA), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, announced today the Japanese approval of the CoRoent Large Impacted (LI) and CoRoent Large Tapered (LT) titanium alloy implants. The implants are used in posterior spine fusion procedures and are NuVasive's first two interbody fusion cages to be approved in Japan. The approvals further the Company's ability to participate in the world's second largest spine market with certain cervical solutions and a comprehensive posterior product offering, which
Source: Market Wire - Pharmaceuticals and Biotech - December 17, 2012 Category: Pharmaceuticals Tags: Pharmaceuticals and Biotech Medical and Healthcare NUVA Source Type: news

BSD Medical Reports Initiation Of A Clinical Study To Treat Recurrent Rectal Cancer With The BSD-2000
BSD Medical Corporation reports initiation of a Phase I/II clinical study (HyRec-Trial) using the BSD-2000 Hyperthermia System (BSD-2000) to deliver hyperthermia in combination with chemotherapy (5-FU/oxaliplatin) and radiotherapy for the treatment of patients with locally recurrent rectal cancer
Source: Medical Design Online News - December 17, 2012 Category: Medical Equipment Source Type: news

Opposition stiffens to ACA’s 2.3% tax on medical devices
Republicans want to repeal the excise tax, and now some Democrats are looking to delay it before it hits companies during the next tax year.
Source: American Medical News - GOVERNMENT - December 17, 2012 Category: American Health Source Type: news

Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Information To Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements
The FDA is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register...
Source: Food and Drug Adminstration (FDA): CDRHNew - December 17, 2012 Category: Medical Equipment Source Type: news

Porcupine Inspiration for Medical Devices?
(Ivanhoe Newswire) – Inspiration can come from anywhere, and sometimes animals are a great source of new ideas. A new study reveals how porcupine quills penetrate tissues and why they are so tough to pull out, leading researchers to believe the knowledge could inspire future medical devices.
Source: Medical Headlines From Ivanhoe.com - December 17, 2012 Category: Consumer Health News Source Type: news

Miracor's PICSO System Is Used For The First Time Under CE Mark In UK To Treat An Acute Heart Attack (STEMI) Patient
Miracor Medical Systems GmbH announced today that its PICSO System was used for the first time under CE mark in the UK to treat a patient with a large acute heart attack (STEMI). Interventional cardiologist Dr. Magdi El-Omar performed the PICSO procedure at Manchester Royal Infirmary (Manchester, England)
Source: Medical Design Online News - December 16, 2012 Category: Medical Equipment Source Type: news

The true nature of recovery: 5 ways to mitigate downtime, data loss
If an army marches on its stomach, does that mean a healthcare provider marches on its data? That may not sound as catchy as its military counterpart, but it rings equally as true. From integrated medical devices to billing to EHRs, data and computer horsepower are mainstays of the healthcare industry. If a hospital's servers fail or if data is lost, it can hamstring a provider until it is restored – if it can be restored. read more
Source: Healthcare IT News - December 14, 2012 Category: Information Technology Authors: Benjamin Harris Tags: Online Only FalconStor imaging Melville New York Ralph Wynn Source Type: news

Mammography Facility Adverse Event and Action Report - December 12, 2012
As part of MQSA, Congress mandated there be annual reporting of adverse actions taken against mammography facilities. Congress stipulated that the report be made available to physicians and the general public and that it should include information that...
Source: Food and Drug Adminstration (FDA): CDRHNew - December 14, 2012 Category: Medical Equipment Source Type: news

Allen Kesselring, Ph.D. of EAG Life Sciences Featured in Special...
Extractables and leachables continue to challenge the pharmaceutical and medical device industry. Allen Kesselring, Ph.D., Scientific Director of EAG Life Sciences, served on an industry roundtable...(PRWeb December 13, 2012)Read the full story at http://www.prweb.com/releases/Allen/Kesselring/prweb10228986.htm
Source: PRWeb: Medical Pharmaceuticals - December 13, 2012 Category: Pharmaceuticals Source Type: news

Covidien's Solitaire FR Revascularization Device Receives Regulatory Approval In Canada
Covidien, a leading global provider of healthcare products, today announced that the Solitaire FR Revascularization Device has been approved by Health Canada
Source: Medical Design Online News - December 13, 2012 Category: Medical Equipment Source Type: news

Notice of Meeting Correction: February 22, 2013 Neurological Devices Panel of the Medical Devices Advisory Committee
Source: Food and Drug Adminstration (FDA): CDRHNew - December 13, 2012 Category: Medical Equipment Source Type: news

Federal Register: Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Correction
The FDA is correcting a notice that appeared in the Federal Register of Friday, December 7, 2012 (77 FR 73034). The product name in the document was incorrect. This document corrects that error.
Source: Food and Drug Adminstration (FDA): CDRHNew - December 13, 2012 Category: Medical Equipment Source Type: news

Class I Medical Device Recall: Ethicon, Inc., SURGIFLO Hemostatic Matrix and SURGIFLO Hemostatic Matrix Kit Plus FlexTip with Thrombin
Reason for Recall: There is an issue within the packing process where a cut could potentially breach the double Tyvek pouch of the packaging. This product may cause serious adverse health consequences, including death.
Source: Food and Drug Adminstration (FDA): CDRHNew - December 13, 2012 Category: Medical Equipment Source Type: news

Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Design Considerations for Devices Intended for Home Use; Availability
The FDA is announcing the availability of the draft guidance entitled "Design Considerations for Devices Intended for Home Use.' This document is intended to assist manufacturers in designing and developing home use medical devices that comply with...
Source: Food and Drug Adminstration (FDA): CDRHNew - December 13, 2012 Category: Medical Equipment Source Type: news

CDRHLearn Course List (New Module - Medical Device User Fee Amendments 2012 - MDUFA III Overview)
New course in the Overview of Medical Device Regulations section.
Source: Food and Drug Adminstration (FDA): CDRHNew - December 13, 2012 Category: Medical Equipment Source Type: news

Roche pressed to refund UK
MPs have called for an inquiry into wasteful spending on drugs, medical devices and implants not supported by full clinical trial data
Source: FT.com - Drugs and Healthcare - December 12, 2012 Category: Pharmaceuticals Source Type: news

A Higher Security Standard for EHRs
“A new, voluntary, private-sector certification program aims to help assure healthcare organizations that electronic health record and health information exchange software, as well as medical devices, meet tough security and interoperability requirements. ICSA Labs, a unit of Verizon, in January will begin testing health IT products to certify that they meet the security and interoperability standard [...]
Source: ICMCC: The International Council on Medical and Care Compunetics - December 12, 2012 Category: Information Technology Authors: Lodewijk Tags: News Certification Health Information Exchange Interoperability Security Standards Source Type: news

Making Medical Devices Safer at Home
Source: Food and Drug Administration Related MedlinePlus Page: Medical Device Safety
Source: MedlinePlus Health News - December 12, 2012 Category: Consumer Health News Source Type: news

BroadcastMed Spotlights KCI ABThera Open Abdomen Negative Pressure Therapy System
ORLive.com, BroadcastMed’s premiere surgical broadcasting website, is proud to present a webcast on the KCI ABThera Open Abdomen (OA) Negative Pressure Therapy (NPT) System
Source: Medical Design Online News - December 12, 2012 Category: Medical Equipment Source Type: news

Industry Sponsorship Leads To Bias In Reported Findings Of Clinical Trials
Studies reporting the results of industry sponsored clinical trials present a more favourable picture of the effects of drugs and medical devices than those reporting on non-industry sponsored trials, according to a new Cochrane systematic review. The researchers call for a rethink of the way that industry bias is handled in medical guidelines and reviews. The outcomes of clinical trials influence the recommendations that doctors make about drugs and other medical interventions...
Source: Health News from Medical News Today - December 12, 2012 Category: Consumer Health News Tags: Clinical Trials / Drug Trials Source Type: news

Foam Technology Helps Stop Battlefield Internal Bleeding
The U.S. military is exploring the use of foam injections as a method to stop internal bleeding of soldiers who are injured during battle. This modern technology could potentially be put to use in the civilian world, aiding in car accident injuries and other serious mishaps that occur far from a hospital. Today, Arsenal Medical Inc. declared that it has been given a Phase II contract from the Defense Advanced Research Projects Agency (DARPA) to back development of its new product to manage intra-abdominal hemorrhage in soldiers who have been hurt on the front lines...
Source: Health News from Medical News Today - December 12, 2012 Category: Consumer Health News Tags: Medical Devices / Diagnostics Source Type: news