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Meeting Announcement: July 18, 2013 Dental Products Panel of the Medical Devices Advisory Committee

May 13, 2013 12:00 am | by U.S. Food & Drug Administration | Comments

On July 18, 2013, the committee will discuss and make recommendations on the proposed regulatory classification for dental devices known as Endosseous Dental Implants (Blade-form), one of the remaining preamendments Class III devices. The Class III blade-form endosseous dental implant is a device placed into the maxilla or mandible and composed of biocompatible material with sufficient strength to support a dental restoration.

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A Rise in the Number of the Aged in Asia-Pacific Widens the Market for Home Care Devices, Finds Frost & Sullivan

May 12, 2013 11:53 pm | by PR Newswire | Comments

KUALA LUMPUR, Malaysia, May 12, 2013 /PRNewswire/ -- Acknowledging the rapid aging of the population in Asia-Pacific, governments are encouraging patients to opt for home care by offering incentives, subsidies and tax cuts. While improving patients' quality of life, home care also...

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Landmark Study Demonstrates Lower Rate of Inappropriate Shocks in Patients with Sorin Dual Chamber ICD Devices

May 11, 2013 10:00 am | by The Associated Press | Comments

DENVER--(BUSINESS WIRE)--May 11, 2013--Sorin Group (MIL:SRN), (Reuters Code: SORN.MI), a global medical company and a leader in the treatment of cardiovascular diseases, announced findings from the landmark OPTION study 1 demonstrating that patients with Sorin dual-chamber implantable cardioverter...

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Background Noise in the Operating Room Can Impair Surgical Team Communication

May 10, 2013 4:43 pm | by American College of Surgeons | Comments

Ambient background noise—whether it is the sound of loud surgical equipment, talkative team members, or music—is a patient and surgical safety factor that can affect auditory processing among surgeons and the members of their team in the operating room (OR), according to a new study that appears in the May issue of the Journal of the American College of Surgeons.

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Data Show Medtronic-Exclusive LIA Software Detects Non-Medtronic Lead Issues at a Greater Rate Than Standard Impedance Monitoring

May 10, 2013 4:06 pm | by The Associated Press | Comments

MINNEAPOLIS and DENVER - May 10, 2013 - Data presented today at Heart Rhythm 2013, the Heart Rhythm Society's 34th Annual Scientific Sessions, show that Medtronic, Inc. (NYSE:MDT) Lead Integrity Alert (LIA) software detected pace/sense lead issues in non-Medtronic leads at a...

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Nanostim Announces Preliminary Results from LEADLESS Study in Late-Breaking Clinical Trial at Heart Rhythm 2013

May 10, 2013 3:42 pm | by The Associated Press | Comments

SUNNYVALE, Calif.--(BUSINESS WIRE)--May 10, 2013--Nanostim, Inc., a privately-owned developer of miniaturized, leadless cardiac pacemakers (LCP), today announced preliminary results from its LEADLESS study during the late breaking clinical trial presentations at Heart Rhythm 2013, the Heart Rhythm...

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Sorin Group Announces FDA Approval and U.S. Launch OF SMARTVIEW Remote Monitoring Solution for Patients with Implanted Cardiac Defibrillators

May 10, 2013 12:04 pm | by The Associated Press | Comments

DENVER--(BUSINESS WIRE)--May 10, 2013--Sorin Group (MIL:SRN), (Reuters Code: SORN.MI), a global medical company and a leader in the treatment of cardiovascular diseases, today announced it received FDA approval for and is beginning the U.S. launch of the SMARTVIEW™ remote monitoring solution for...

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Medtronic Issues Statement on iPad Interference Study

May 10, 2013 11:02 am | by Medtronic | Comments

Medtronic's current internal analysis and testing shows iPad technology presents no risk of electromagnetic interference with Medtronic implantable cardiac rhythm devices when used per manufacturer's instructions. However, as a precaution, patients implanted with a pacemaker or ICD are advised to follow Apple and Medtronic labeling recommendations and maintain a distance of six inches between the iPad and implanted device.

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Building Protocells from Inorganic Nanoparticles

May 10, 2013 11:00 am | by University of Bristol | Comments

Researchers at the University of Bristol have led a new enquiry into how extremely small particles of silica (sand) can be used to design and construct artificial protocells in the laboratory. The work is described in an article published in Nature Chemistry.

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Flawed Diamonds Promise Sensory Perfection

May 10, 2013 10:48 am | by Lawrence Berkeley National Laboratory | Comments

From brain to heart to stomach, the bodies of humans and animals generate weak magnetic fields that a supersensitive detector could use to pinpoint illnesses, trace drugs – and maybe even read minds. Sensors no bigger than a thumbnail could map gas deposits underground, analyze chemicals, and pinpoint explosives that hide from other probes.

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Biomaterial Shows Promise for Type 1 Diabetes Treatment

May 10, 2013 10:41 am | by Georgia Tech | Comments

Researchers have made a significant first step with newly engineered biomaterials for cell transplantation that could help lead to a possible cure for Type 1 diabetes, which affects about 3 million Americans. Georgia Tech engineers and Emory University clinicians have successfully engrafted insulin-producing cells into a diabetic mouse model, reversing diabetic symptoms in the animal in as little as 10 days.

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Operating Without Interrupting Warfarin Reduces Risk of Bleeding After Cardiac Device Surgery

May 10, 2013 10:21 am | by University of Ottawa Heart Institute | Comments

A new Canadian study shows that operating without interrupting warfarin treatment at the time of cardiac device surgery is safe and markedly reduces the incidence of clinically significant hematomas compared to the current standard of care. The new findings were released today at Heart Rhythm 2013, the Heart Rhythm Society's 34th Annual Scientific Sessions.

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Life Care Medical Devices Ltd Announces Addition Of Dublin, Ireland Based European Subsidiary

May 10, 2013 7:04 am | by The Associated Press | Comments

Life Care Medical Devices Ltd (OTCBB:LCMD) today announced the opening of their European subsidiary offices in Dublin, Ireland.  Life Care Medical Devices Ltd, Ireland will manage all aspects of the company's European business. "With a strong, solid history in the medical device arena,...

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Canada’s Sunnybrook Health Sciences Centre Joins Elekta and Philips Research Consortium on MRI-Guided Radiation Therapy

May 10, 2013 1:46 am | by The Associated Press | Comments

STOCKHOLM, Sweden--(BUSINESS WIRE)--May 10, 2013--Regulatory News: Elekta (NSE: EKTAb) and Royal Philips Electronics (NYSE: PHG, AEX: PHIA) announced today that Sunnybrook Health Sciences Centre (Toronto, Canada) will join their growing consortium to validate the clinical potential of MRI-guided...

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Globus Medical Launches FORTIFY® I Integrated Expandable Corpectomy System

May 9, 2013 7:06 pm | by The Associated Press | Comments

AUDUBON, Pa.--(BUSINESS WIRE)--May 9, 2013--Globus Medical, Inc. (NYSE: GMED), a leading spinal implant manufacturer, today announced the launch of FORTIFY ® I, an expandable corpectomy spacer with integrated screws for further stability in addition to supplemental fixation. “The FORTIFY ® I...

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