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Medtronic Nets New Indications for Resolute Integrity Drug-Eluting Stent in Europe

May 15, 2012 11:57 am | News | Comments

As EuroPCR 2012 gets under way today, Medtronic, Inc. announced that the Resolute Integrity Coronary Stent System has received European regulatory approval for several new indications, making it the drug-eluting stent (DES) with the broadest range of approved indications...

Idaho Technology Receives FDA 510(k) Clearance for Expanded FilmArray Respiratory Panel

May 15, 2012 11:54 am | News | Comments

Idaho Technology, Inc., a privately held clinical diagnostics company dedicated to providing the world's fastest, highest-quality instruments for pathogen identification and DNA analysis, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of five...

New Score Can Tell Surgeons How They Perform on the Da Vinci Robot

May 15, 2012 11:45 am | News | Comments

A first of its kind assessment system has been developed by a team of researchers to more reliably predict whether surgeons are ready to operate on patients using the da Vinci robot. The new technology, called MScore, provides more precise analysis of actual surgical performance...


Boston Scientific Announces Positive Data From Lotus Transcatheter Aortic Valve Trial

May 15, 2012 11:43 am | News | Comments

Boston Scientific Corporation announces results from the REPRISE I feasibility trial, which evaluated the acute safety of the Lotus™ Aortic Valve System in patients with severe aortic valve disease.  The Lotus Aortic Valve System is the first transcatheter aortic valve replacement...

Fluke Biomedical launches speedy new ProSim SPOT Light SpO2 Functional Tester

May 15, 2012 11:40 am | News | Comments

Fluke Biomedical announced today the newest addition to their ProSim family of patient monitor quality-assurance testing and troubleshooting tools, the SPOT Light SpO2 Functional Tester. Citing a record 15-second preventive maintenance (PM) test for SpO2 patient monitor...

Upcoming Webinar on Hearing Aids: The Basic Information You Need to Know (5/23/12)

May 15, 2012 9:30 am | by U.S. Food & Drug Administration | News | Comments

Learn more Wednesday, May 23, 2012 at 2:00 p.m. ET, when FDA's Center for Devices and Radiological Health (CDRH) will host a 30-minute Webinar to discuss basic information on Hearing Aids.

Researchers Say Urine Dipstick Test is Accurate Predictor of Renal Failure in Sepsis Patients

May 15, 2012 5:53 am | News | Comments

Henry Ford Hospital researchers have found that the presence of excess protein in a common urine test is an effective prognostic marker of acute renal failure in patients with severe sepsis.Researchers analyzed data from 328 sepsis patients with no previous history...

Impending IEC 60601 Leaves Medical Companies Struggling with Rules on Sustainable Design

May 15, 2012 5:48 am | News | Comments

The issue of ‘sustainability’ is becoming increasingly important for the medical industry since the implementation of the ‘International standard for environmentally conscious design of electronic medical equipment’ (IEC 60601-1-9) introduced in 2007.


Boston Scientific and Philips Healthcare Announce Collaboration to Enhance Imaging Equipment Offering

May 15, 2012 5:45 am | News | Comments

Boston Scientific Corporation and Royal Philips Electronics announced a collaboration enabling Philips to sell Boston Scientific Imaging equipment in connection with its Allura Xper™ catheterization (cath) lab systems in territories throughout the world.

Increasing Use of Smart Pumps to help drive down 'Never Events'

May 15, 2012 5:35 am | News | Comments

Increased focus on providing optimum patient care in the most cost efficient way is fuelling demand for intelligent infusion devices termed “Smart Pumps.” A report from InMedica, a division of IMS Research (recently acquired by IHS Inc.), on the global market...

NovationAwards EarlySense’s Continuous and Contact-Free, Proactive Patient Monitoring System New Innovative Technology Status

May 15, 2012 5:33 am | News | Comments

EarlySense, a market leader in proactive patient care solutions, announced today that it has signed an agreement with Novation, the leading health care supply contracting company for the members of VHA Inc., UHC, and Provista LLC. Novation has awarded...

Stander's Medi HYDRA PAK Wins Innovation Award at Spring Medtrade 2012 Product Show

May 15, 2012 5:29 am | News | Comments

With an arsenal of new and unique products to start the 2012 year, Stander Inc., leading maker of senior home safety devices, entered the Spring Medtrade 2012 product show with high expectations. They left with bragging rights, as three of their products won major awards...

Stander's LifeStrength Wristband Wins Award for Innovation at Spring Medtrade 2012 Product Show

May 15, 2012 5:26 am | News | Comments

While negative ion technology has been questioned in the past, Stander's LifeStrength wristband blew skeptics away at the Spring Medtrade 2012 Product Show, winning the Innovation Award for Best New Product. The LifeStrength wristband was one of three award-winning Stander products.


Bioness Announces FDA Clearance of Smaller Leg Cuff for Use with its L300 Foot Drop System

May 15, 2012 5:24 am | News | Comments

Bioness Inc. today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market a smaller leg cuff for use with the company’s L300® Foot Drop System. The L300 is a neuromodulation technology designed to treat foot drop...

PneumRx, Inc. Receives FDA Approval to Commence Pivotal Clinical Trial of RePneu Lung Volume Reduction Coil System

May 15, 2012 5:22 am | News | Comments

PneumRx, Inc., a medical device company dedicated to bringing innovation and improvements to the treatment of lung disease, today announced that it has received FDA approval to commence a 30-site pivotal clinical trial to support a PMA application for the RePneu LVRC System.

Hydromorphone Hydrochloride Injection 1 MG/ML, (C-II) 1 ML Fill In 2.5 ML Carpuject: Recall - May Contain More Than the Intended Fill Volume

May 14, 2012 9:30 am | by U.S. Food & Drug Administration | News | Comments

An overdose of Hydromorphone may result in life-threatening consequences, including respiratory depression (slowed breathing or suspension of breathing), low blood pressure, and reduced heart rate including circulatory collapse.

Curetis AG Achieves CE-Marking for Unyvero Solution and Initiates Commercialization

May 14, 2012 5:15 am | News | Comments

Curetis AG, an innovative molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic products for infectious diseases, today announced that the company has achieved the CE marking for its Unyvero™ suite of instruments...

Study Shows Robotically Enhanced PCI IS Safe and Feasible for Many Patients

May 14, 2012 5:04 am | News | Comments

A robotic system can safely assist interventional cardiologists in performing percutaneous coronary interventions (PCI) while significantly reducing the physician's exposure to radiation and improving precision and control, according to results of the PRECISE study...

Study of First-in-Class Watchman Device Shows 75% Reduction in Stroke Risk in Patients with Atrial Fibrillation not Eligible for Oral Anticoagulation Therapy

May 14, 2012 4:58 am | News | Comments

Boston Scientific Corporation announces results from the ASA Plavix (ASAP) Study, which studied the WATCHMAN® Left Atrial Appendage Closure (LAAC) device. The data showed a reduction in the risk of ischemic stroke by 75 percent in patients with atrial fibrillation...

Industry: IRS Needs to Better Define & #8216;Taxable Use & #8217; in Excise Tax Rule

May 11, 2012 2:30 pm | by U.S. Food & Drug Administration | News | Comments

Internal Revenue Service guidelines on the 2.3 percent medical device tax should make clear that manufacturers won’t have to pay taxes on products from which they derived no direct benefit, such as demonstration products and replacement parts provided free of charge, AdvaMed said in...

MDUFA Moves to House Floor, Decision Summaries for Some 510(k)s Likely

May 11, 2012 2:30 pm | by U.S. Food & Drug Administration | News | Comments

An omnibus FDA user fee bill passed last week by the House Energy and Commerce Committee includes a variety of measures aimed at reforming the medical device regulatory process, including a provision requiring the FDA to withdraw its controversial guidance on when manufacturers should...

Researchers Use Light to Switch On Gene Expression

May 10, 2012 10:49 am | News | Comments

Imagine being able to control genetic expression by flipping a light switch. Researchers at North Carolina State University are using light-activated molecules to turn gene expression on and off. Their method enables greater precision when studying gene function, and could lead...

Discovery in cell signaling could help fight against melanoma

May 10, 2012 10:43 am | News | Comments

The human body does a great job of generating new cells to replace dead ones but it is not perfect. Cells need to communicate with or signal to each other to decide when to generate new cells. Communication or signaling errors in cells lead to uncontrolled cell growth...

iCAD Announces First European Patients Treated with Xoft Radiation Therapy System

May 10, 2012 10:34 am | News | Comments

iCAD, Inc., an industry-leading provider of advanced image analysis, workflow solutions and radiation therapy for the early identification and treatment of cancer, announced the first European patients have been treated with the Xoft Axxent® Electronic Brachytherapy System.

FDA Safety Communication: Chronic Cerebrospinal Venous Insufficiency Treatment in Multiple Sclerosis Patients

May 10, 2012 6:30 am | by U.S. Food & Drug Administration | News | Comments

The FDA is alerting people with MS to the risks of serious injuries and death associated with procedures to treat chronic cerebrospinal venous insufficiency (CCSVI). Furthermore, the benefits of these experimental procedures have not been proven...

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