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pSivida Announces Second Tech Evaluation Agreement with its BioErodible Durasert Technology

March 13, 2012 12:08 pm | News | Comments

WATERTOWN, Mass.--(BUSINESS WIRE)--pSivida Corp., a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today announced that it has entered into a technology evaluation agreement for its bioerodible Durasertâ„¢ drug delivery technology...

Interventional Cardiology Device Markets in Pakistan, Saudi Arabia, South Africa and Turkey to Grow to $461 Million by 2016

March 13, 2012 12:05 pm | News | Comments

TORONTO--(BUSINESS WIRE)--According to Millennium Research Group (MRG), the global authority on medical technology market intelligence, the interventional cardiology (IC) market in Pakistan, Saudi Arabia, South Africa and Turkey will reach a value of more than $460 million by 2016.

Federal Circuit Decides Masimo, Represented by Knobbe Martens, Is The First Inventor of Additional Breakthrough Patient Care Technology

March 13, 2012 11:55 am | News | Comments

IRVINE, Calif.--(BUSINESS WIRE)--Knobbe Martens today announced that the Federal Circuit affirmed a decision by the U.S. Patent and Trademark Office (USPTO) holding that Masimo was the first to invent breakthrough measure-through-motion pulse oximetry technology.

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Hospira Receives FDA Clearance for Symbiq 3.13 Infusion Pump

March 13, 2012 11:48 am | News | Comments

LAKE FOREST, Ill., -- Hospira, Inc., the world's leading provider of injectable drugs and infusion technologies, announced today that the company has received regulatory clearance from the U.S. Food and Drug Administration (FDA) for the Symbiq™ 3.13 infusion device, the enhanced version...

2000°F Inert Atmosphere Heavy-Duty Box Furnace

March 12, 2012 6:10 am | The Grieve Corporation | Product Releases | Comments

No. 954 is an electrically-heated 2000°F(~1093°C) inert atmosphere heavy-duty box furnace from Grieve, currently used for heat treating titanium at the customer’s facility. 57 KW are installed...

New Evidence Supports Positive Outcomes of Cooled Radiofrequency Therapy for Low Back Pain

March 12, 2012 5:16 am | News | Comments

Kimberly-Clark Health Care today announced the results of a randomized controlled trial on the use of cooled radiofrequency (RF) to treat sacroiliac joint (SIJ) pain in the lower back. The results were published in the March edition of Pain Medicine, official journal of the American Academy...

Asahi Kasei Announces Agreement to Acquire ZOLL Medical

March 12, 2012 5:12 am | News | Comments

Asahi Kasei, through a U.S. subsidiary, will make a cash tender offer to purchase all of the outstanding shares of ZOLL common stock for $93 per share. The purchase price represents a premium of 29.6% over ZOLL's volume weighted average closing stock price over the 30 trading day period...

Synthes Slapped With Wrongful Deaths Suit, FDA Warning Letter

March 9, 2012 1:31 pm | by U.S. Food & Drug Administration | News | Comments

Swiss devicemaker Synthes faces trouble from two sides, with an FDA warning letter posted just days after the company was sued by the families of two patients who died on the operating table during illegal clinical trials.

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OIG Finds No Basis to Prosecute & #8216;FDA Nine & #8217; Over Personal Emails

March 9, 2012 1:31 pm | by U.S. Food & Drug Administration | News | Comments

After consulting with Justice Department prosecutors, the HHS Office of Inspector General (OIG) has found nothing to substantiate the FDA’s claim that it began monitoring nine employees’ emails only after hearing that confidential industry information had been leaked to the...

Gerber Good Start Gentle Powdered Infant Formula: Recall - Off-Odor

March 9, 2012 8:30 am | by U.S. Food & Drug Administration | News | Comments

Reports of gastrointestinal complaints.

BSD Medical Sells MicroThermX Microwave Ablation System to Appleton Medical Services

March 9, 2012 5:10 am | News | Comments

SALT LAKE CITY--(BUSINESS WIRE)--BSD Medical Corporation, a leading provider of medical systems that utilize heat therapy to treat cancer, announced today that the Company continues an aggressive rollout of its successful MicroThermX® Microwave Ablation System equipment rental program throughout the U.S.

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

March 8, 2012 10:45 am | by The Associated Press | 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...

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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.

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

March 8, 2012 5:30 am | by U.S. Food & Drug Administration | 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 | by U.S. Food & Drug Administration | 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 | by U.S. Food & Drug Administration | 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.

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

March 6, 2012 7:32 am | by U.S. Food & Drug Administration | 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 | by U.S. Food & Drug Administration | 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...

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...

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