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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...

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.

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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...

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...

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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.

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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.

Argatroban Injection 50 mg/50 mL (1 mg/mL): Recall - Potential for Visible Particulates

March 23, 2012 10:30 am | by U.S. Food & Drug Administration | News | Comments

Risk of embolization/infarction to organs and potential organ complications.

CDRH Learn (New Module - ISO 13485:2003 Voluntary Audit Report Submission Pilot Program)

March 23, 2012 8:31 am | by U.S. Food & Drug Administration | News | Comments

This presentation explains FDA's new voluntary audit report submission pilot program, which is based on ISO 13485, an international standard utilized in the medical-device sector in many places around the world.

Itamar-Medical Launches Next-Generation, Cardiovascular Health Assessment Platform

March 22, 2012 11:41 am | News | Comments

CAESAREA, Israel--(BUSINESS WIRE)--Itamar-Medical, the leading provider of diagnostic devices for cardiovascular disease and sleep apnea based on its proprietary PAT® signal technology, will unveil its cardiovascular healthcare assessment platform, EndoPAT-MF, at the upcoming...

Meridian Companies Announces 'LipoLaser' Lawsuit Ends

March 22, 2012 11:39 am | News | Comments

VANCOUVER, British Columbia--(BUSINESS WIRE)--Meridian Companies (“Meridian”), a medical device company focused on the manufacturing and distribution of wellness and medical devices, is pleased to announce that the lawsuit between Meridian and Erchonia Corporation (Erchonia) has ended.

Fenwal, Applied Science Sign Agreement for HemoFlow 400 Blood Monitor and Mixer in Europe

March 22, 2012 11:37 am | News | Comments

LAKE ZURICH, Ill.--(BUSINESS WIRE)--Fenwal, Inc. announced today it has begun marketing, selling and distributing the HemoFlow 400 blood collection monitor/mixer in Europe under a new agreement with the device's manufacturer, Applied Science, Inc.

NeuroLogica Corporation Receives CE Mark Approval for BodyTom

March 22, 2012 11:35 am | News | Comments

DANVERS, Mass.--(BUSINESS WIRE)--NeuroLogica Corporation announced today it has received CE Mark approval for its most recent product BodyTomâ„¢, a portable, full body, multi-slice CT scanner. CE Mark approval allows BodyTom â„¢ to be sold in the European Union.

Toshiba's Newest Ultrasound Systems Offer Breakthrough Imaging Technologies and Advanced Cardiac Capabilities

March 22, 2012 11:33 am | News | Comments

CHICAGO--(BUSINESS WIRE)--Improving the ability to diagnose cardiac disease with advanced ultrasound imaging, Toshiba America Medical Systems, Inc. will showcase the newest additions to its ultrasound product line, AplioTM 500 and Aplio 300 at this year's American College of Cardiology...

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