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Class I Medical Device Recall: Thoratec Corporation, HeartMate II Left Ventricular Assist System (LVAS)

April 4, 2012 9:31 am | by U.S. Food & Drug Administration | News | Comments

Detachment of the bend relief from its intended position around the proximal outflow graft may allow the graft to kink or deform, resulting in reduction of blood flow from the HeartMate II LVAS pump, pump/graft thrombosis, or perforation of the outflow...

Research demonstrates bacterial contamination in pharmacy robots

April 4, 2012 7:35 am | News | Comments

Chicago -- Drug dispensing robots designed to quickly prepare intravenous medications in a sterile environment can harbor dangerous bacteria, according to a report in Infection Control and Hospital Epidemiology, the journal of the Society for Healthcare Epidemiology of America.

Mobile technology helps explore nicotine addiction

April 4, 2012 7:33 am | News | Comments

Some people quit smoking on the first try while others have to quit repeatedly. Using such mobile technology as hand-held computers and smartphones, a team of researchers from Penn State and the University of Pittsburgh is trying to find out why.

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Covidien Prevails in Patent Action against Applied Medical Resources

April 4, 2012 5:32 am | News | Comments

MANSFIELD, Mass.--(BUSINESS WIRE)--Covidien, a leading global provider of healthcare products, announced that it has prevailed against Applied Medical Resources Corp. in a patent action before the U.S. District Court, Central District of California.

Altuzan (bevacizumab): Counterfeit Product - Contains no Active Ingredient

April 3, 2012 2:31 pm | by U.S. Food & Drug Administration | News | Comments

The counterfeit product may have resulted in patients not receiving needed therapy.

Experts Weigh in on Considering Bariatric Surgery for Patients with Diabetes

April 2, 2012 7:47 am | News | Comments

Chevy Chase, MD— The Endocrine Society released a statement today emphasizing that while bariatric surgery may help obese patients lose weight and can lead to diabetes remission, it may not be the best option for every diabetic patient with obesity. The statement was written...

Florida Hospital Carrollwood Purchases Mazor Robotics’ Renaissance System

April 2, 2012 5:30 am | News | Comments

CAESAREA, Israel--(BUSINESS WIRE)--Mazor Robotics Ltd, the leader in innovative surgical robots and complementary products for spine surgery, today announced that Florida Hospital Carrollwood, a 120-bed community hospital in Tampa, FL, has purchased a Renaissance™ system.

Terumo Interventional Systems Introduces the Azur Detachable 35 Peripheral Framing Coil

April 2, 2012 5:11 am | News | Comments

SOMERSET, NJ – Terumo Interventional Systems, a strategic business unit of Terumo Medical Corporation, and one of the leading manufacturers of guidewires, catheters, sheaths, and embolization products, today announced the nationwide availability of the AZUR® D35 Framing Coil...

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Wingspan Stent & #8217;s Benefits Don & #8217;t Justify Risks, Panel Concludes

March 30, 2012 1:31 pm | by U.S. Food & Drug Administration | News | Comments

Stryker’s Wingspan stent could be yanked from the market if the FDA heeds March 23 recommendations of its Neurological Devices Panel.

Shuren Predicts CDRH & #8216;Death Spiral & #8217; Absent Timely MDUFA Passage

March 30, 2012 1:31 pm | by U.S. Food & Drug Administration | News | Comments

CDRH would move into a “death spiral” if Medical Device User Fee Act (MDUFA) legislation is not reauthorized this summer, director Jeffrey Shuren warned at a Senate Health, Education, Labor & Pensions (HELP) committee hearing Thursday.

Oticon, Inc. Introduces Invisible Hearing Device For People Who Want the Ultimate in Discretion

March 30, 2012 6:52 am | News | Comments

SOMERSET, N.J.--(BUSINESS WIRE)--Oticon, Inc. today introduced a tiny new hearing instrument that may make it easier for people with a strong preference for an “invisible” hearing solution to take the first step toward better hearing. On the opening day of the American Academy of Audiology AudiologyNOW!...

Siemens Aims to Improve Hearing Aid Acceptance with XCEL — the New Generation of BestSound Technology

March 30, 2012 6:49 am | News | Comments

BOSTON--(BUSINESS WIRE)--Siemens Hearing Instruments, Inc. today announced XCEL - the new generation of its clinically proven* BestSoundâ„¢ Technology. XCEL accelerates hearing aid acceptance by optimally balancing speech intelligibility and sound quality for each individual hearing...

Lantos Technologies Launches World's First 3D Direct Ear Scanner

March 30, 2012 6:45 am | News | Comments

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Lantos Technologies today announced the launch of its 3D digital scanner for fast and painless measurement of the ear canal. The small, hand-held portable scanner using Lantos' patented dual-wavelength algorithm technology is the first platform...

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Global Market for Home Medical Equipment to Reach $26.2 Billion in 2016

March 30, 2012 6:31 am | News | Comments

Wellesley, Mass. – According to a new technical market research report, GLOBAL MARKETS AND TECHNOLOGIES FOR HOME MEDICAL EQUIPMENT (HLC054C) from BCC Research, the global market for home medical equipment was valued at $18.9 billion...

Cutting Edge Spine announces commercial availability of new family of PEEK-OPTIMA- based spinal interbody systems

March 30, 2012 5:46 am | News | Comments

Cutting Edge Spine, LLC., Waxhaw, NC - Cutting Edge Spine (CES), an emerging leader in the supply of interbody implant systems for surgery of the spine, today announced commercial availability of the E-Vol System of spinal fusion devices. A 510k cleared family of spinal interbody systems...

Celexa (citalopram hydrobromide) - Drug Safety Communication: Revised Recommendations, Potential Risk of Abnormal Heart Rhythms

March 28, 2012 5:31 am | by U.S. Food & Drug Administration | News | Comments

Revised drug label clarifying dosing and warning recommendations.

Guidance: Class II Special Controls Guidance Document: Full Field Digital Mammography System

March 27, 2012 11:30 am | by U.S. Food & Drug Administration | News | Comments

FDA has developed this guidance as the special control to support classification of full-field digital...

New FDA guidance on considerations used in device approval, de novo decisions

March 27, 2012 7:30 am | by U.S. Food & Drug Administration | News | Comments

FDA has published a first-of-a-kind guidance for medical device manufacturers, describing how the benefits...

Pilot Would Reduce Audit Frequency Using Harmonized Regulations

March 23, 2012 2:31 pm | by U.S. Food & Drug Administration | News | Comments

Starting June 5, devicemakers audited according to internationally harmonized regulatory standards could be spared some annual FDA inspections, under a pilot program described in a final guidance.

U.S. Supreme Court Prometheus Ruling May Limit Future Research

March 23, 2012 2:31 pm | by U.S. Food & Drug Administration | News | Comments

Last week’s U.S. Supreme Court decision on the patent eligibility of a diagnostic could have ramifications for in vitro diagnostic (IVD) devicemakers, limiting investment in novel tests because of uncertainty about what is and is not patentable, a U.S. patent attorney tells D&DL.

Parker Medical and LMA Vitaid Announce Canadian Distribution Agreement

March 23, 2012 12:30 pm | News | Comments

LMA Vitaid in Ontario, Canada and Parker Medical in Highlands Ranch, Colorado are pleased to announce an exclusive distribution agreement under which LMA Vitaid will sell and distribute the full line of Parker Medical's innovative airway management products throughout Canada.

Medgenics Cleared to Initiate Phase IIa Anemia Study of EPODURE Biopump in Dialysis Patients in Israel

March 23, 2012 10:58 am | News | Comments

MISGAV, Israel and SAN FRANCISCO--(BUSINESS WIRE)--Medgenics, Inc., the developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced receipt of clearance from the Israeli Ministry of Health...

Canon U.S.A. Showcases the RK-F2 Full Auto Ref-Keratometer at Vision Expo East

March 23, 2012 10:53 am | News | Comments

NEW YORK--(BUSINESS WIRE)--Canon U.S.A., Inc., a leader in digital imaging solutions, will demonstrate the benefits of using its digital imaging and workflow management solutions, including the Canon RK-F2 Full Auto Ref-Keratometer, during Vision Expo East, March 23 – 25, at the Jacob K. Javits...

St. Jude Medical Announces Next-Generation PressureWire for FFR Measurement

March 23, 2012 10:50 am | News | Comments

ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc., a global medical device company, today announced it has received U.S. Food and Drug Administration (FDA) clearance for multiple enhancements to its PressureWireâ„¢ Fractional Flow Reserve (FFR) measurement guidewire.

US Medical Innovations, LLC Announces the First Worldwide Clinical Application of the Canady Vieira Hybrid Plasma Scalpel

March 23, 2012 10:40 am | News | Comments

TAKOMA PARK, Md.--(BUSINESS WIRE)--US Medical Innovations, LLC announces the first clinical applications of the Canady Vieira Hybrid Plasma Scalpel. On December 9, 2011 the FDA issued a 510K premarket notification of the Canady Vieira Hybrid Plasma Scalpel.

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