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Lloydspharmacy Partners With Proteus Biomedical to Launch Innovative Digital Health Product

January 16, 2012 5:10 am | News | Comments

REDWOOD CITY, Calif.--(BUSINESS WIRE)--UK community pharmacy chain Lloydspharmacy and US company Proteus Biomedical, Inc., a pioneer in digital health, have today announced an exclusive strategic collaboration to commercialize and launch Heliusâ„¢, a digital health product...

Air Techniques' Polaris Given 'Top Intraoral Camera of 2012' Award

January 16, 2012 5:06 am | News | Comments

MELVILLE, N.Y.--(BUSINESS WIRE)--Air Techniques, Inc., a leading dental equipment manufacturer, announced today that its Polaris Intraoral Camera has been awarded Top Intraoral Camera of 2012 by THE DENTAL ADVISOR. Polaris offers superior optics and a broad focal range...

Evaluation of Automatic Class III Designation (De Novo) Decision Summaries: K102333 added

January 14, 2012 9:31 am | by U.S. Food & Drug Administration | News | Comments

The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the "De Novo" classification option as an alternate pathway to classify certain new devices that had automatically been placed in Class III due to lack of a predicate.


FDA Asks TV Mesh Manufacturers to Conduct Postmarket Studies

January 13, 2012 1:31 pm | by U.S. Food & Drug Administration | News | Comments

Surgical mesh manufacturers have until Feb. 3 to submit their plans to the FDA for conducting postmarket studies under Section 522 of the 1938 FD&C Act.

MDUFA Agreement Progresses, But Sticking Points Remain

January 13, 2012 1:31 pm | by U.S. Food & Drug Administration | News | Comments

FDA-industry negotiations to reauthorize the Medical Device User Fee Act (MDUFA) went down to the wire last week, as CDRH seemed destined to miss a Jan. 15 due date for sending a commitment letter to Congress.

Adcetris (brentuximab vedotin): Drug Safety Communication - Progressive Multifocal Leukoencephalopathy and Pulmonary Toxicity

January 13, 2012 7:31 am | by U.S. Food & Drug Administration | News | Comments

New Boxed Warning and Contraindication highlighting these risks added to product labeling.

US Trauma Device Market to Show Moderate Growth Reaching Nearly $3.8 Billion by 2016

January 13, 2012 5:30 am | News | Comments

TORONTO--(BUSINESS WIRE)--According to Millennium Research Group (MRG), the global authority on medical technology market intelligence, the United States trauma device market, will grow at a steady pace through 2016. Pricing pressures from the increasing influence of group...

Data from St. Jude Medical's ASSERT Implantable Device Monitoring Study Published in New England Journal of Medicine

January 13, 2012 5:26 am | News | Comments

ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, a global medical device company, today announced the publication of results from the ASSERT cohort study in the New England Journal of Medicine (NEJM). The ASSERT study, or ASymptomatic AF and Stroke Evaluation...


MagnaCare Announces Partnership with Telcare, Developers of Only Wireless Blood Glucose Meter (BGM) on the Market

January 13, 2012 5:23 am | News | Comments

NEW YORK & BETHESDA, Md.--(BUSINESS WIRE)--MagnaCare, a health plan management company, announced today its partnership with Bethesda, M.D.-based Telcare, Inc. in order to provide a unique level of quality care to its clients living with diabetes. Through this partnership...

Carestream Health Earns 47 U.S. Patents in 2011 for Advances in Radiology, Dental and Molecular Products

January 13, 2012 5:20 am | News | Comments

ROCHESTER, N.Y.--(BUSINESS WIRE)--Carestream and its subsidiaries were awarded 47 patents in 2011 for innovations in its radiology imaging and healthcare IT, dental imaging and molecular imaging products from the U.S. Patent and Trademark Office. These new patents include...

Endosense Launches TactiCath 75 Force-Sensing Catheter, Announces New Results of EFFICAS I Clinical Study

January 13, 2012 5:14 am | News | Comments

GENEVA--(BUSINESS WIRE)--Endosense, a pioneer and leader in force-sensing technology focused on improving the efficacy and safety of catheter ablation for the treatment of cardiac arrhythmias, has announced the European launch of the TactiCath 75 force-sensing ablation catheter...

RaySearch Laboratories: RayStation 2.5 released

January 13, 2012 5:08 am | News | Comments

STOCKHOLM--(BUSINESS WIRE)--Regulatory News: RaySearch Laboratories AB announces that version 2.5 of RaySearch's RayStation® treatment planning system has been released for clinical use in Europe and USA and is pending regulatory approval in Canada.

Biosense Webster Completes Enrollment in Ground-Breaking SMART-AF Trial

January 13, 2012 5:05 am | News | Comments

DIAMOND BAR, Calif.--(BUSINESS WIRE)--Biosense Webster Inc., a worldwide leader in the diagnosis and treatment of cardiac arrhythmias, announced the completion of enrollment in their latest ground-breaking clinical trial, the SMART-AF Investigational Device Exemption (IDE) study.


Biosense Webster Announces FDA approval of the THERMOCOOL SF Catheter in the United States

January 13, 2012 5:03 am | News | Comments

DIAMOND BAR, Calif.--(BUSINESS WIRE)--Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of cardiac arrhythmias, announced the FDA approval of the new THERMOCOOL® SF irrigated ablation catheter in the United States. The THERMOCOOL® SF NAV Catheter...

Biomet Receives FDA Clearance for Two New Products: E1 Humeral Bearing for the Comprehensive Reverse Shoulder System and the Comprehensive Segmental Revision System

January 13, 2012 5:00 am | News | Comments

WARSAW, Ind.--(BUSINESS WIRE)--Biomet, Inc., a global leader in the manufacture of orthopaedic and biotechnology products, today announced clearance of two new products by the United States Food and Drug Administration (FDA): the E1® humeral bearing for use with the...

Circadiance to Launch New Respiratory Supply Products

January 13, 2012 4:52 am | News | Comments

PITTSBURGH /PRNewswire/ -- One of the premier providers of innovative supplies for continuous positive airway pressure (CPAP) products, Circadiance celebrates the completion of its fifth year with a variety of planned new product launches. These launches promise to build upon...

Bedford Laboratories Polymyxin B For Injection USP And Vecuronium Bromide For Injection: Recall - Glass Particles

January 12, 2012 8:31 am | by U.S. Food & Drug Administration | News | Comments

Particulate matter in injections can be harmful when introduced into the bloodstream.

Innovation Pathway

January 12, 2012 6:30 am | by U.S. Food & Drug Administration | News | Comments

The Innovation Pathway aims to shorten the overall time it takes for the development, assessment, and review of breakthrough medical devices.

Bacterial Infections: New Laboratory Method Uses Mass Spectrometry to Rapidly Detect Staph Infections

January 12, 2012 5:19 am | News | Comments

Researchers from the Georgia Institute of Technology and the Centers for Disease Control and Prevention (CDC) have developed a new laboratory test that can rapidly identify the bacterium responsible for staph infections. This new test takes advantage of unique isotopic...

Riverain Technologies' Temporal Comparison X-ray Software Receives FDA Clearance

January 12, 2012 5:15 am | News | Comments

DAYTON, Ohio--(BUSINESS WIRE)--Riverain Technologies announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA) for its Temporal Comparison software. This software electronically compares current and prior chest X-ray images and...

GE Healthcare to Enhance EP Portfolio of Offerings through Biosense Webster Agreement

January 12, 2012 5:08 am | News | Comments

WAUKESHA, Wis.--(BUSINESS WIRE)--GE Healthcare announced today a long-term agreement with Biosense Webster, Inc., in which the companies will co-distribute their leading electrophysiology (EP) systems - including GE's CardioLab* EP Recording Systems and Biosense Webster's...

Optovue and Carl Zeiss Meditec Have Reached Settlement in Their Current Patent Infringement Disputes

January 12, 2012 5:05 am | News | Comments

FREMONT, Calif. & DUBLIN, Calif.--(BUSINESS WIRE)--Optovue Inc. and Carl Zeiss Meditec Inc. announced today that they have signed a settlement agreement resolving two pending Federal District Court patent infringement cases. Under the terms of the agreement, the companies dismissed...

Ford Collaborates with Microsoft, Healthrageous and BlueMetal Architects for In-Car Health and Wellness Research

January 12, 2012 4:54 am | News | Comments

LAS VEGAS – Ford, Microsoft, Healthrageous and BlueMetal Architects announced an alliance today to research technology to help people monitor and maintain health and wellness while on the move. The alliance was unveiled during the “Doctor in Your Car” keynote address...

Consumer Information on: Berlin Heart EXCOR & #xae; Pediatric Ventricular Assist Device (VAD) - H100004

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

The EXCOR® Pediatric VAD is a blood pump that vibrates rhythmically and is designed to assist patients who cannot pump enough blood with their own natural heart. The device can be used in patients who cannot effectively pump blood with their left and/or..

Parkinson treatment shows positive results in clinical testing

January 11, 2012 5:09 am | News | Comments

GAINESVILLE, Fla. - Researchers from the University of Florida and 14 additional medical centers reported results today in the online version of The Lancet Neurology journal indicating that deep brain stimulation - also known as DBS - is effective at improving motor symptoms...

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