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Ascom's Mobile Monitoring Gateway Achieves MDD Clearance

November 2, 2011 4:24 am | News | Comments

GOTHENBURG, Sweden--(BUSINESS WIRE)--Ascom Wireless Solutions, a leading supplier of mission critical on-site wireless communications announced today that they have received Medical Device Directive clearance by the Swedish Medical Products Agency for their Mobile Monitoring Gateway (MMG).

New Brain Aneurysm Treatment at Stanford Hospital Supplies Hope

November 2, 2011 4:22 am | News | Comments

STANFORD, Calif.--(BUSINESS WIRE)--If Barbara Maluo's brain aneurysm had been discovered a few months ago, she would have had few viable treatment options. She was one of the 10 to 15 percent of brain aneurysm patients diagnosed each year with aneurysms so large and wide...

Invuity Introduces Advanced Illuminated Surgical Devices for Spinal Procedures

November 2, 2011 4:18 am | News | Comments

CHICAGO, Nov. 2, 2011 /PRNewswire/ -- Invuity, a leading developer of state-of-the-art illuminated surgical technology, today announced that it will introduce a new line of surgical devices that provide surgeons enhanced visibility during spinal surgeries.


Solvay Announces Integra LifeSciences Agreement to Use Eviva® PSU in Integra's Brain Shunt Valves

November 2, 2011 4:06 am | News | Comments

ALPHARETTA, Ga., November 1, 2011– Implantable brain shunt valves from Integra LifeSciences Corporation, Plainsboro, N.J., a leading medical device manufacturer, are partially composed of Eviva® polysulfone (PSU) resin from Solvay Specialty Polymers USA, LLC. Eviva PSU resin is part of Solvay's...

DSM's Dyneema Purity® fiber selected for use in SpineWorks, LLC's new Universal Screw Persuader

November 2, 2011 3:52 am | News | Comments

DSM, a global leader in biomedical materials, today announced that its Dyneema Purity® ultra-high-molecular-weight-polyethylene fiber was selected for use in SpineWorks, LLC's novel Universal Screw Persuader (USP)System. The patent pending USP is a Class 1 disposable system...

Mazor Robotics Systems Guide Placement of Over 15,000 Spine Implants WorldwideMazor Robotics Systems Guide Placement of Over 15,000 Spine Implants Worldwide

November 1, 2011 9:37 pm | News | Comments

CAESAREA, Israel--(BUSINESS WIRE)--Mazor Robotics Ltd (TASE: MZOR), the pioneer in innovative surgical robots and complementary products for spine surgery, announced that its clinically proven technology has been used to guide placement of more than 15,000 spinal implants...

Stratatech Awarded $4.6-Million Clinical Trial Grant for ExpressGraftâ„¢ Antimicrobial Skin Substitute

November 1, 2011 8:46 pm | News | Comments

MADISON, Wis.--(BUSINESS WIRE)--Stratatech Corp., a leader in regenerative medicine, today announced that the company has been awarded a $4.6-million grant by the National Institute of Diabetes and Digestive and Kidney Diseases to support the first human clinical trial of Stratatech's ExpressGraftâ„¢ antimicrobial skin substitute.

ROX Medical Announces First Clinical Use of the ROX FLO2W Procedure for the Treatment of High Blood Pressure in Resistant Hypertension Patients

November 1, 2011 8:42 pm | News | Comments

SAN CLEMENTE, Calif.--(BUSINESS WIRE)--ROX Medical, Inc., a world leader in the development of unique minimally invasive medical devices for the treatment of advanced COPD and resistant hypertension, today announced the first clinical use of the ROX CO2UPLERTM at the Universitair Ziekenhuis Brussel...


Zynex Expands Product Line

November 1, 2011 8:39 pm | News | Comments

LONE TREE, Colo.--(BUSINESS WIRE)--Zynex, Inc. (OTCBB: ZYXI), a provider and developer of non-invasive medical devices for electrotherapy, stroke rehabilitation, neurological diagnosis and cardiac monitoring, announced that it has signed a private labeling and distribution agreement with ActivaTek...

Toshiba's Dual Plane X-Ray System Enables Faster and Easier Cardiac, Peripheral Interventions for Patients

November 1, 2011 8:34 pm | News | Comments

NEW ORLEANS--(BUSINESS WIRE)--Enabling clinicians to seamlessly transition between cardiac and peripheral intervention during a single procedure, InfinixTM DP-i cardiovascular X-ray system from Toshiba America Medical Systems, Inc. will be used in eight live cases at Peripheral Angioplasty...

Public Workshop - Using Scientific Research Data to Support Pediatric Medical Device Claims, December 5, 2011

November 1, 2011 12:31 pm | by U.S. Food & Drug Administration | News | Comments

The purpose of the public workshop is to receive public comment on the use of scientific research data, including published scientific literature, to extrapolate effectiveness claims from adults to children and between pediatric subpopulations in order...

Medtronic Receives First FDA Approval of Cobalt Chromium Balloon-Expandable Stent to Treat Narrowed Iliac Arteries

October 31, 2011 9:14 am | News | Comments

MINNEAPOLIS –– Oct. 31, 2011 –– Advancing the treatment of peripheral artery disease, Medtronic, Inc. (NYSE: MDT) today announced approval by the U.S. Food and Drug Administration (FDA) of the Assurant® Cobalt Iliac Balloon-Expandable Stent System.

Understanding Barriers to Medical Device Quality

October 31, 2011 4:30 am | by U.S. Food & Drug Administration | News | Comments

Provides an in-depth look at challenges industry and the FDA face in implementing well-integrated, best-quality manufacturing practices. The report also presents recommendations on ways industry and the FDA can work to remove the perceived barriers to...


FDA Ban on OTC Inhalers Under Senate Assault

October 28, 2011 2:31 pm | by U.S. Food & Drug Administration | News | Comments

An FDA ban on over-the-counter asthma inhalers containing chlorofluorocarbons would be voided by a bill introduced by Sen. Pat Roberts (R-Kan.).

Guidance Threatens Huge Jump In 510(k) Filings, AdvaMed Warns

October 28, 2011 2:31 pm | by U.S. Food & Drug Administration | News | Comments

The FDA stands to receive 300 to 500 percent more 510(k) submissions if the agency implements a draft guidance on when to file a 510(k) for a change to an existing device, AdvaMed says.

Spinal USA Gets FDA Approval for Two New Spinal Treatment Products

October 28, 2011 10:46 am | News | Comments

PEARL, Miss.--(BUSINESS WIRE)--Spinal USA, LLC announced today that it will introduce two new additions to the company's portfolio of spinal treatment solutions at this year's meeting of the North American Spine Society (NASS) in Chicago, IL, November 1-5.

Physician Prescriptions for ZOLL LifeVest Top 50,000

October 28, 2011 10:33 am | News | Comments

CHELMSFORD, Mass.--(BUSINESS WIRE)--ZOLL Medical Corporation (NasdaqGS: ZOLL), a manufacturer of medical devices and related software solutions, announced today that more than 50,000 patients at high risk of sudden cardiac arrest (SCA) have been prescribed the LifeVest® Wearable Defibrillator.

Disposable vs. Durable

October 28, 2011 10:03 am | by David Fink | Articles | Comments

A question must be addressed at the start of any new medical device product development process, “Will the device or a component be disposable or be durable?” With safety being of paramount importance, cost and “green” considerations also enter into the equation. This article examines both options and the considerations that must be taken into account for each.

Lighthouse Imaging Announces Patent for Endolume Endoscopic Test Device

October 28, 2011 7:53 am | News | Comments

PORTLAND, MAINE -- Lighthouse Imaging Corporation ( ) announces that a key element of its Endolume testing device has been issued Patent #8040496 from the US Patent and Trademark Office. Endolume is a portable handheld device...

ICUS Applauds FDA Modification of Boxed Warnings on Certain Ultrasound Contrast Agents; Cite Patient Benefit

October 28, 2011 7:46 am | News | Comments

WASHINGTON--(BUSINESS WIRE)--International Contrast Ultrasound Society (ICUS) today applauded the FDA's decision to modify the U.S. product label for DEFINITY® Injectable Suspension, an ultrasound contrast agent. Ultrasound contrast agents are approved in the U.S. for cardiac imaging...

FDA Advisory Panel Makes Recommendation on Investigational Medtronic Phased RF Ablation System for Treatment of Persistent or Long-Standing Persistent Atrial Fibrillation

October 28, 2011 7:44 am | News | Comments

MINNEAPOLIS--(BUSINESS WIRE)--Medtronic, Inc. (NYSE: MDT) today announced that the U.S. Food and Drug Administration's (FDA) Circulatory Systems Devices advisory panel voted against the Medtronic Phased RF Ablation System, the first atrial fibrillation ablation therapy under investigation...

Boston Biomedical Associates helps AtriCure's Synergy Ablation System win a Recommendation from FDA Expert Advisors

October 28, 2011 7:39 am | News | Comments

NORTHBOROUGH, Mass.--(BUSINESS WIRE)--Boston Biomedical Associates today announced that AtriCure, Inc., a medical device company and a leader in cardiac surgical ablation systems and devices for the exclusion of the left atrial appendage, received a vote of approval support...

Avinger Debuts Kittycat 2 Catheter and Juicebox in US and EU Markets, Two Innovative Tools for the Treatment of Peripheral Artery Disease (PAD)

October 27, 2011 11:57 am | News | Comments

REDWOOD CITY, Calif.--(BUSINESS WIRE)--Avinger, Inc., a medical device manufacturer of innovative, multi-functional catheters for treating patients with Peripheral Artery Disease (PAD), announces today the release of two new products, Kittycat 2, a smaller more refined ultimate support catheter, and Juicebox...

SpineOvations Receives European Patent for Treatment of Ligaments and Tendons

October 27, 2011 11:55 am | News | Comments

SAN DIEGO--(BUSINESS WIRE)--SpineOvations, a San Diego-based medical technology company focused on the development of new and innovative products, announced today that it has been granted a patent in Europe for its novel injectable composition technology for treatment and repair of any ligaments and tendons in the human body.

Stealth Therapeutics' Invisiportâ„¢ Implantable Arm Port Receives FDA Clearance

October 27, 2011 11:53 am | News | Comments

MADISON, Wis.--(BUSINESS WIRE)--Stealth Therapeutics Inc. announced today that the company has received clearance from the U.S. Food and Drug Administration (FDA) to market its Invisiportâ„¢ product. The Invisiport offers a less invasive, patient-friendly alternative to traditional chest ports...

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