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Presentation of Preliminary Results From Boston Scientific PREVAIL Clinical Trial Now Available

March 9, 2013 9:29 am | by Bio-Medicine.Org | News | Comments

Boston Scientific Corporation (NYSE: BSX ) announces the preliminary analysis of the PREVAIL clinical trial data is now available on TCTMD.  PREVAIL evaluates the safety and efficacy of the WATCHMAN® Left Atrial Appendage (LAA) Closure device in patients with nonvalvular atrial...

STENTYS Self-Apposing® Stent Demonstrates Lowest Mortality Rate Among Large Heart Attack Trials

March 9, 2013 9:00 am | by The Associated Press | News | Comments

PRINCETON, N.J. & PARIS--(BUSINESS WIRE)--Mar 9, 2013--STENTYS (FR0010949404 – STNT), a medical technology company commercializing in Europe the world's first and only Self-Apposing ® Stent to treat acute myocardial infarction (AMI), announced today one-year results of the APPOSITION III...

DNA Sequencing Giant Illumina Joins Hunt for Autism Blood Test

March 8, 2013 4:37 pm | by Massachusetts Institute of Technology | News | Comments

Illumina will work with SynapDx’s to find a blood-test that could allow treatment to start earlier. Massachusetts startup SynapDx announced on Wednesday that it will work with DNA sequencer manufacturer Illumina  to develop early detection tools for autism spectrum disorders, according to a release.

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Jury Deems J&J's Depuy ASR XL Hip Implant Defective in Design, Orders $8.3M in Damages

March 8, 2013 2:20 pm | by Mass Device | News | Comments

A California jury ruled against Johnson & Johnson and its DePuy subsidiary in finding that the company's ASR XL metal-on-metal hip implant was defectively designed. The decision marks the highly anticipated close of the 1st of more than 10,750 such lawsuits against J&J.

Report: Boston Scientific Issues Alert on Its Lead-Free S-ICD Defibrillator

March 8, 2013 1:43 pm | by Mass Device | News | Comments

Boston Scientific recently issued a warning on its lead-free implantable defibrillators over concerns that a fuse malfunction could prevent the devices from delivering life-savings shocks. The company has received reports of four instances in which a fuse inside the subcutaneous ICD was activated inappropriately.

Information Update - Important Information for Hospira Infusion Pump Users

March 8, 2013 12:15 pm | by PR Newswire | News | Comments

OTTAWA, March 8, 2013 /CNW/ - Health Canada is informing Canadians and Canadian health care practitioners that Hospira Inc., a drug and medical device manufacturer, is voluntarily stopping all new sales of its intravenous infusion pumps while it addresses issues in its quality...

EXTENSION® Showcases First-of-its-Kind Enterprise Care Team Collaboration and Communication Solution at AONE

March 8, 2013 11:36 am | by The Associated Press | News | Comments

FORT WAYNE, Ind.--(BUSINESS WIRE)--Mar 8, 2013--EXTENSION, INC., the developer of award-winning critical alerting and alarm management software for hospitals, announced today that it will continue its national unveiling of EXTENSION Engage™ - a unified care team collaboration solution – at the...

Hernia: Covidien's Biologic Mesh Product Hits a Wall

March 8, 2013 11:23 am | by Mass Device | News | Comments

Covidien's biologic hernia mesh product has hit a "brick wall," according to CFO Charles Dockendorff, but does that mean the company is looking to move on from the product it dropped more than $80 million to acquire? Dockendorff, responding to a question from CitiGroup analyst Matthew Dodds at the investment bank's recent investor's conference...

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Diabetes: LifeScan Nabs First FDA-Cleared Mobile Health Blood Glucose Monitoring System

March 8, 2013 9:12 am | by Mass Device | News | Comments

LifeScan, has received regulatory clearance from the FDA for its OneTouch VerioSync blood glucose monitoring system, the first monitoring system to integrate with the Apple app store. The app, called the OneTouch Reveal, is available on iPhone, iPad or iPod touch.

St. Jude Medical Announces First Implant in Pivotal Phase of Clinical Trial Evaluating AMPLATZER Cardiac Plug for the Prevention of Stroke in Patients with Atrial Fibrillation

March 8, 2013 8:00 am | by The Associated Press | News | Comments

ST. PAUL, Minn.--(BUSINESS WIRE)--Mar 8, 2013--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the first patient implant in a new pivotal trial evaluating the company’s AMPLATZER ™ Cardiac Plug (ACP) for the prevention of stroke. The AMPLATZER ™ Cardiac Plug...

Cardiac Dimensions® Completes Patient Enrollment in TITAN II Clinical Trial

March 8, 2013 8:00 am | by PR Newswire | News | Comments

KIRKLAND, Wash., March 8, 2013 /PRNewswire/ -- Cardiac Dimensions®, Inc. today announced that it has completed enrollment in its TITAN II clinical trial, a follow-up to the landmark TITAN clinical trial of the Company's CARILLON® Mitral Contour System®....

Endeavor Power Corporation Introduces Its Proprietary FDA Cleared Target System Platform Technology

March 8, 2013 8:00 am | by PR Newswire | News | Comments

CAMBRIDGE, Mass., March 8, 2013 /PRNewswire/ -- Endeavor Power Corporation ("Endeavor Power" or the "Company") (OTCQB: EDVP) introduces its proprietary FDA Cleared Target System Platform Immunoassay Testing Technology ("Target System"). Endeavor Sciences, Inc. ("Endeavor"), the...

Ad-Tech Brain Implant Recall Gets FDA's Highest-Risk Status

March 8, 2013 7:29 am | by Mass Device | News | Comments

Federal healthcare regulators gave Ad-Tech Medical Instrument Corp.'s wide-reaching brain implant recall Class I status, the highest-risk category for medical device recalls. Late last year the Wisconsin-based medical device maker recalled its Macro Micro Subdural Electrodes over concerns that the implanted devices could cause damage to the brain.

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Philips Delivers New Innovations to Make Imaging Accessible to More Patients

March 8, 2013 3:27 am | by Bio-Medicine.Org | News | Comments

Royal Philips Electronics is introducing three new imaging systems to help radiology departments increase both the number of patients and range of clinical exams they can handle. Philips is continuing the Imaging 2.0 journey to deliver greater collaboration and integration, increased patient focus and improved economic value.

Draft Guidance for Industry and Food and Drug Administration Staff - Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex

March 8, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The purpose of this guidance is to make recommendations on the appropriate language to include in the labeling of a medical product to convey that natural rubber latex was not used as a material in the manufacture of the product or product container...

First Telescopic Implant in Connecticut for Macular Degeneration

March 7, 2013 10:57 pm | by PR Newswire | News | Comments

CHESHIRE, Conn., March 7, 2013 /PRNewswire-iReach/ -- Dr. Randolph Kinkade has been recently interviewed on WFSB's Your Health and WTNH's Health News discussing this new technology.  Dr. Kinkade, a Connecticut optometrist, is a founding member of the International Academy of Low...

Breakthrough in Artificial Intelligence-Based Robotics Neurosurgery

March 7, 2013 2:37 pm | by Bio-Medicine.Org | News | Comments

Imaging and robotic technologies have the potential to help neurosurgeons perform precise, fast and more comprehensive testing of brain tissue during surgery, identification of cancer type, grade and tumor margins and help them navigate through the brain, according to Akash Singh , PhD. Akash Singh , PhD, performs his scientific...

The Brain Activity Map

March 7, 2013 2:26 pm | by Massachusetts Institute of Technology | News | Comments

Researchers explain the goals and structure of a new brain-mapping project. A proposed effort to map brain activity on a large scale, expected to be announced by the White House later this month, could help neuroscientists understand the origins of cognition, perception, and other phenomena.

Funding: Nevro Corp. Lands $48M in Support of Spinal Cord Stimulation Tech

March 7, 2013 1:12 pm | by Mass Device | News | Comments

Menlo Park, Calif.-based Nevro Corp. raised $48 million in a Series C financing round in support of its high-frequency spinal cord stimulation technology, including investments from Covidien Ventures and Johnson & Johnson Development Corp. Nevro develops and markets the Senza HF-SCS system for treatment of chronic pain and other disorders.

Crystal Clinic Orthopaedic Center Purchases Carestream Digital Radiology Systems to Streamline Workflow

March 7, 2013 1:00 pm | by The Associated Press | News | Comments

ROCHESTER, N.Y.--(BUSINESS WIRE)--Mar 7, 2013--Crystal Clinic Orthopaedic Center (CCOC), a partnership with Summa Health System (Akron, Ohio), purchased a CARESTREAM Vue PACS and 14 Carestream and Quantum DR systems to streamline workflow and help its 34 orthopaedic and two plastic surgeons...

CellAegis Devices Receives Marketing Authorization from Health Canada for the autoRICT Device to Provide Non-Invasive Remote Ischemic Conditioning (RIC)

March 7, 2013 12:34 pm | by The Associated Press | News | Comments

CellAegis Devices, Inc. announced today that it has received marketing authorization from Health Canada that allows for the commercial introduction in Canada of the Company's autoRICT Device for Remote Ischemic Conditioning (RIC). Health Canada has granted a Medical Device Class III license...

FDA Considers Patent Extension for Edwards' Sapien TAVI Heart Implant

March 7, 2013 10:29 am | by Mass Device | News | Comments

Federal healthcare regulators review Edwards Lifesciences request for an extension to patents for its Sapien transcatheter aortic valve implantation system, the only such device on the U.S. market. Drawings from Edwards Lifesciences' U.S. Patent No. 5,411,552.

Medtronic Submits IDE to FDA for U.S. Randomized Clinical Trial for Uncontrolled Hypertension Patients with Systolic Blood Pressure Between 140-160 mm Hg

March 7, 2013 10:19 am | by The Associated Press | News | Comments

Medtronic, announced today that the company has submitted an Investigational Device Exemption to the U.S. FDA to study the Symplicity renal denervation system for the treatment of uncontrolled hypertension in patients with systolic blood pressure between 140-160 mm Hg despite treatment with three or more anti-hypertensive medications of different classes.

Avinger Announces Primary Investigators for Upcoming VISION Trial

March 7, 2013 10:00 am | by The Associated Press | News | Comments

REDWOOD CITY, Calif.--(BUSINESS WIRE)--Mar 7, 2013--Avinger, Inc., designer of therapeutic devices incorporating intravascular imaging, and pioneer of the lumivascular approach to treating vascular disease, announces the designation of the primary investigators for its upcoming global VISION...

FDA Updates Guidance on Pulse Oximeter Applications

March 7, 2013 9:29 am | by Mass Device | News | Comments

The FDA issued new guidance governing premarket notification submissions for pulse oximeters. The new guidelines apply to all 510(k) submissions for the non-invasive blood oxygen level and pulse rate measuring devices. In the guidance, published March 4, the FDA specified new rules for identifying, testing and assuring safety for the systems.

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