Advertisement
Device Sectors
Subscribe to Device Sectors
View Sample

FREE Email Newsletter

NAMSA Opens Office near Frankfurt for EU Clinical Trial & Regulatory Support

March 8, 2012 10:45 am | News | Comments

NAMSA Opens Office near Frankfurt for EU Clinical Trial & Regulatory Support NORTHWOOD, Ohio--(BUSINESS WIRE)--Mar 8, 2012-- NAMSA, a leading medical device research organization, recently announced the opening of its newest office near Frankfurt, Germany. Staff with regulatory and quality...

Avinger Enrolls First U.S. PAD Patient in CONNECT II Global Clinical Trial

March 8, 2012 5:43 am | News | Comments

Avinger, Inc., a medical device manufacturer of innovative, multi-functional catheters for treating patients with Peripheral Artery Disease (PAD), announces the enrollment of the first U.S. patient in the CONNECT II global clinical trial. Dr. Ian Cawich of Arkansas Heart Hospital...

German Left Atrial Appendage Device Market to Challenge Novel Anticoagulants

March 8, 2012 5:39 am | News | Comments

According to Millennium Research Group (MRG), the global authority on medical technology market intelligence, procedures for Left Atrial Appendage (LAA) devices, intended to minimize stroke risk in patients with atrial fibrillation, have grown by over 200 percent in Germany since 2010.

Advertisement

Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Norovirus Serological Reagents

March 8, 2012 5:30 am | News | Comments

This special controls guidance document was developed to support the classification into class II (special controls) of norovirus serological reagents. These devices detect norovirus antigens in human fecal specimens as an aid in the diagnosis of...

Irish Hospital Uses Elekta's Clarity 3D Ultrasound to Guide Prostate Cancer Radiotherapy

March 8, 2012 5:30 am | News | Comments

Soft tissue imaging with 3D ultrasound both at therapy simulation and just before treatment has transformed prostate radiotherapy at University Hospital Galway (UHG). The majority of radiotherapy patients with prostate cancer who visit the clinic will benefit from a new technology...

Summary Information for: ION? Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire Delivery Systems)

March 7, 2012 6:30 am | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for ION? Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire Delivery Systems) (P100023S015).

Summary Information for: Resolute MicroTrac Zotarolimus-Eluting Coronary Stent System (Resolute MicroTrac) and Resolute Integrity Zotarolimus-Eluting Coronary Stent System (Re...

March 7, 2012 4:30 am | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for Resolute MicroTrac Zotarolimus-Eluting Coronary Stent System (Resolute MicroTrac) and Resolute Integrity Zotarolimus-Eluting Coronary Stent System (Resolute Integrity) (P110013).

Mayo Clinic Announces Collaboration on New Progranulin Blood Test for Dementia

March 6, 2012 8:20 am | News | Comments

Mayo Clinic today announced that Mayo Medical Laboratories has signed an agreement with A&G Pharmaceutical, Inc. and will receive a non-exclusive license to certain patent rights and proprietary antibody reagents for the detection and measurement of progranulin in blood.

Advertisement

Consumer Information on: Breast Companion & #xae; Software System - P100007

March 6, 2012 7:32 am | News | Comments

The Breast Companion® Software System is a computer-aided report-generating system intended to improve the ACR BI-RADS® (American College of Radiology, Breast Imaging Reporting and Data System) assessment of ultrasound images of lesions of the...

Summary Information for: Breast Companion & #xae; Software System

March 6, 2012 7:32 am | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for Breast Companion® Software System (P100007).

Medtronic Receives CE Mark for Pacemaker Lead That Will Expand Patient Access to MRI Technology

March 6, 2012 4:54 am | News | Comments

Medtronic, Inc. today announced the receipt of CE Mark (Conformité Européenne) and launch of the CapSure Sense MRI™ SureScan® pacing leads, which are approved for use during Magnetic Resonance Imaging (MRI). Medtronic introduced the first MR-Conditional pacemaker system in the world in 2008 and in the U.S. in 2011.

Covidien Revascularization Device Receives FDA Clearance

March 6, 2012 4:52 am | News | Comments

Covidien, a leading global provider of healthcare products, today announced that the Solitaireâ„¢ FR revascularization device has been cleared by the U.S. Food and Drug Administration. The Solitaire FR device is intended to restore blood flow to the brain in patients suffering acute ischemic stroke by mechanically removing blood clots from blocked vessels.

Amedica Announces Launch of New Facet Joint Implant

March 6, 2012 4:50 am | News | Comments

Amedica Corporation, a spinal and reconstructive implant and instrument manufacturer, focused on proprietary silicon nitride (Si3N4) ceramic technologies, announced today the launch of a new spinal implant called Procetâ„¢. Procet has been designed to treat patients who suffer from low back pain...

Advertisement

Houston Medical Robotics, Inc. Receives FDA 510(k) Clearance for Euclid Tier 1 Mini Access System

March 6, 2012 4:48 am | News | Comments

Houston Medical Robotics, Inc. announces that it has received U.S. Food and Drug Administration 510(k) clearance to market the Euclidâ„¢ Tier 1 Mini Access System. The Euclidâ„¢ Tier 1 Mini Access System is a portable, hand-held device that integrates commercially available...

Preventing Protein Build Up on In-Vivo Devices and Biosensors

March 5, 2012 11:32 am | Articles | Comments

Biosensors are critical components of diagnostic devices. They are tiny, integrated circuit chips that transmit readings from within the body to an external component that displays data for physicians and patients. Biosensors have many applications including important roles in continuous glucose monitors, sensors that monitor cell health, and magnetic sensors associated with microlabels and microfluidic cartridges, just to name a few. A big obstacle facing biosensors that are implanted into the body is longevity.

Summary Information for: Ovation Abdominal Stent Graft System

March 5, 2012 5:31 am | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for Ovation Abdominal Stent Graft System (H100008).

Consumer Information on: OVATION Abdominal Stent Graft System - H100008

March 5, 2012 5:31 am | News | Comments

The OVATION abdominal stent graft system is used to treat abdominal aortic aneurysms during endovascular repair (EVAR). An aneurysm is a diseased, bulging, weak section of an artery wall; in this case the aorta. The main portion of the OVATION abdominal..

Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators (AEDs): Class I Recall - Defective Compo...

March 2, 2012 2:31 pm | News | Comments

Unexpected component failure may lead to AEDs not delivering defibrillation therapy, causing serious adverse health consequences, including death.

Class I Medical Device Recall: Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators - AEDs

March 2, 2012 7:30 am | News | Comments

The affected AEDs contain a component that may fail unexpectedly due to a defect. If the component were to fail during a rescue attempt, the AED may not deliver defibrillation therapy causing serious adverse health consequences

SurModics' Hydrophilic Coating on Medtronic's Resolute IntegrityT Drug-Eluting Stent Delivery System

March 1, 2012 11:45 am | News | Comments

SurModics' Hydrophilic Coating on Medtronic's Resolute IntegrityT Drug-Eluting Stent Delivery System EDEN PRAIRIE, Minn.--(BUSINESS WIRE)--Mar 1, 2012-- SurModics, Inc. (Nasdaq: SRDX), a leading provider of surface modification and in vitro diagnostic (IVD) technologies to the healthcare...

Statins and HIV or Hepatitis C Drugs: Drug Safety Communication - Interaction Increases Risk of Muscle Injury

March 1, 2012 11:30 am | News | Comments

Protease inhibitors and statins taken together may raise the blood levels of statins and increase the risk of myopathy, kidney damage, and kidney failure, which can be fatal.

Cannulated Bar Tubular Materials

March 1, 2012 5:33 am | Product Releases | Comments

Banner Medical has announced a long term exclusive agreement with Veridiam, Inc. (formerly Carpenter Special Products) of San Diego, California. Under this agreement...

Safety tips for intense pulsed light therapy

March 1, 2012 4:31 am | News | Comments

Article originally published in Nursing2012, February issue. DEVICE SAFETY INTENSE PULSED LIGHT (IPL) therapy is indicated for use in surgical, aesthetic, and cosmetic applications. IPLs use flashlamps, computercontrolled power supplies, and bandpass...

Statin Drugs - Drug Safety Communication: Class Labeling Change

February 28, 2012 8:30 am | News | Comments

New adverse event and liver enzyme monitoring information in statin labels and updated drug interactions information in lovastatin label.

X
You may login with either your assigned username or your e-mail address.
The password field is case sensitive.
Loading