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Hospital for Special Surgery Taps Accelarad for Medical Image Sharing

March 5, 2013 10:00 am | by The Associated Press | News | Comments

ATLANTA--(BUSINESS WIRE)--Mar 5, 2013--Accelarad, a leading provider of secure, cloud-based medical imaging solutions, and creators of SeeMyRadiology.com, announced today that Hospital for Special Surgery (HSS) has selected Accelarad’s medical imaging solution to improve medical image sharing and...

CircuLite® Receives Conditional IDE Approval for SYNERGY® Circulatory Support System Feasibility Trial

March 5, 2013 9:00 am | by The Associated Press | News | Comments

CircuLite®, Inc. today announced that it has received conditional approval from the United States Food and Drug Administration (FDA) of an Investigational Device Exemption (IDE) for its lead product, the SYNERGY® Circulatory Support System, a minimally-invasive device designed to reverse the symptoms of heart failure in ambulatory chronic heart failure patients.

Misonix BoneScalpelT Highlighted In New Clinical Paper Aimed At Face And Jaw Surgery

March 5, 2013 7:01 am | by The Associated Press | News | Comments

Misonix, Inc. (NasdaqGM: MSON), an international surgical device company that designs, manufactures and markets innovative therapeutic ultrasonic products for spine surgery, skull-based surgery, neurosurgery, wound debridement, cosmetic surgery, laparoscopic surgery and other surgical ...

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Data Standards and Terminology Standards for Information Submitted to CDRH

March 5, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The Center for Devices and Radiological Health (CDRH) encourages manufacturers to use data and terminology standards in pre-market submissions and post-market reports for medical devices. The FDA can review and analyze data and information more quickly...

Innovative HiFocus Mid-Scala Electrode from Advanced Bionics Receives Approval in Canada

March 4, 2013 5:00 pm | by The Associated Press | News | Comments

VALENCIA, Calif.--(BUSINESS WIRE)--Mar 4, 2013--Advanced Bionics (AB), a global leader in cochlear implant technology and a company of the Sonova Group, announced today that it received Health Canada approval for the HiFocus™ Mid-Scala* electrode. Last month, AB received TÜV approval for...

Neuro Devices Maker Recalls Implanted Electrodes over Brain Damage Concerns

March 4, 2013 2:29 pm | by Mass Device | News | Comments

Wisconsin-based medical device maker Ad-Tech Medical Instrument Corp. launched a wide-reaching recall of its Macro Micro Subdural Electrodes over concerns that the implanted devices could cause damage to the brain. The recall extends to devices manufactured from June 2006 to March 2012, according to an FDA notice.

Lower Extremity Functional Electrical Stimulation Cycling Promotes Physical & Neurological Recovery in Chronic Spinal Cord Injury

March 4, 2013 2:27 pm | by Bio-Medicine.Org | News | Comments

BALTIMORE , March 4, 2013 /- A new study by Kennedy Krieger Institute's International Center for Spinal Cord Injury (Epub ahead of print) finds that long-term lower extremity functional electrical stimulation (FES) cycling, as part of a rehabilitation regimen, is associated with substantial improvements in individuals with chronic spinal cord injury (SCI).

Peripheral Artery Disease: Mercator MedSystems Wins CE Mark for Catheter Systems

March 4, 2013 12:12 pm | by Mass Device | News | Comments

Mercator MedSystems touted European regulatory approvals for a pair of micro-infusion catheters for the treatment of peripheral artery disease. The San Leandro, Calif.-based medical device company received CE Mark approval in the European Union to market its Cricket and Bullfrog catheters, which are designed to inject therapeutic agents safely through blood vessel walls into deep tissues.

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Cardiovascular Systems to Present Pivotal Orbit II Coronary Data at the 2013 American College of Cardiology Conference

March 4, 2013 11:00 am | by The Associated Press | News | Comments

ST. PAUL, Minn., & SAN FRANCISCO--(BUSINESS WIRE)--Mar 4, 2013--Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), will present data from its ORBIT II study of coronary artery disease at the 2013 American College of Cardiology (ACC) conference in San Francisco, Mar. 9–11, 2013. This marks the...

Medtronic Approved to Update Resolute Integrity Stent’s CE Mark Labeling on Dual Antiplatelet Therapy

March 4, 2013 10:27 am | by Medtronic | News | Comments

Of relevance to the clinical practice of interventional cardiology, Medtronic announced that it has received regulatory approval to update the CE mark labeling for the Resolute Integrity drug-eluting stent with new information on one month of dual antiplatelet therapy, the shortest minimum duration referenced on the label for any device of its kind.

Welch Allyn Will Showcase the EarlySense Contact-Free Patient Monitoring and Electronic Vitals Documentation Systems at HIMSS13

March 4, 2013 10:24 am | by Welch Allyn | News | Comments

Welch Allyn, a leading medical diagnostic device company that specializes in helping clinicians improve patient outcomes, will showcase the EarlySense Vitals Surveillance System at the Healthcare Information and Management Systems Society (HIMSS) trade show this week at the Ernest N. Morial Convention Center in New Orleans.

Analogic Completes Acquisition of Ultrasonix

March 4, 2013 10:22 am | by GLOBE NEWSWIRE | News | Comments

Analogic Corporation, enabling the world's medical imaging and aviation security technology, announced today that it has completed the acquisition of Ultrasonix Medical Corporation for a purchase price of approximately $83 million, subject to a final adjustment as provided in the purchase agreement.

Lanx Announces Initial Launch of ALTA Stand-Alone System for Anterior Cervical Fusion

March 4, 2013 10:15 am | by GLOBE NEWSWIRE | News | Comments

Lanx, Inc., a privately held global spine company focused on developing and commercializing innovative devices for fusion surgery, today announced the initial launch of the ALTA(TM) Stand-Alone ACDF System for a less invasive approach to anterior cervical fusion.

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Asian Portable Heart Monitor Demand Drives Expansion of Global Diagnostic Cardiology Device Market

March 4, 2013 10:08 am | by IMS Research | News | Comments

Pumped up by rising demand in Asia for portable heart monitors, the global market for diagnostic cardiology devices is set to expand by 12 percent from 2011 to 2016, according a new report from IMS Research, now part of IHS. Worldwide market revenue for diagnostic cardiology devices is projected to rise to $882 million in 2016, up from $786 million in 2011.

FDA Clears Philips' MicroDose SI Mammography System

March 4, 2013 9:29 am | by Mass Device | News | Comments

Technology giant Philips won FDA clearance for its MicroDose SI full-field mammography system, which the company hopes to leverage as a platform new mammogram imaging applications. The system promises reduced radiation dosages in producing high quality images, 5-minute exam times and ergonomic design with curved and warmed breast support.

EarlySense Introduces Innovative, Contact-Free, Patient Safety Monitoring System for Avoiding Adverse Events to the HIMSS Convention in New Orleans, March 3-7, 2013

March 4, 2013 9:15 am | by The Associated Press | News | Comments

NEW ORLEANS & WALTHAM, Mass.--(BUSINESS WIRE)--Mar 4, 2013--EarlySense Ltd., the market leader in Proactive Patient Care Solutions™, announced today that it will be demonstrating the company’s contact-free, continuous, patient safety monitoring solution at the Healthcare Information and...

Larry Cohen Appointed CEO of Exalenz Bioscience

March 4, 2013 8:30 am | by The Associated Press | News | Comments

MODIIN, Israel--(BUSINESS WIRE)--Mar 4, 2013--Exalenz Bioscience (TASE: EXEN), a developer of a unique medical device intended for the diagnostics and management of disease of the digestive tract and the liver, has reported today the appointment of Larry Cohen as the company's CEO.

Virtua and Alere Form Alliance for Care Coordination

March 4, 2013 8:01 am | by The Associated Press | News | Comments

Virtua, a healthcare delivery leader in southern New Jersey, and Alere Inc. (NYSE: ALR), a global leader in health information solutions, announced today a strategic alliance to provide health information systems and home-based, biometric monitoring devices to support care coordination ...

Capital BlueCross Announces Designation of IPG as their Implantable Device Benefit Management Partner

March 4, 2013 8:00 am | by The Associated Press | News | Comments

ATLANTA--(BUSINESS WIRE)--Mar 4, 2013--Capital BlueCross and IPG, the leading nationwide provider of implantable Device Benefit Management™ (DBM) solutions, are pleased to announce an exclusive agreement to provide a comprehensive DBM program to participating facilities in Capital BlueCross’...

Cerapedics Announces 10,000th Patient Treated With i-FACTOR™ Peptide Enhanced Bone Graft

March 4, 2013 7:45 am | by The Associated Press | News | Comments

WESTMINSTER, Colo.--(BUSINESS WIRE)--Mar 4, 2013--Cerapedics, Inc. (Westminster, CO), a medical device company pioneering the use of peptide enhanced bone grafting materials in spine, trauma and orthopedic surgery, is pleased to announce it has surpassed another significant milestone with more...

Types of Communication During the Review of Medical Device Submissions - Draft Guidance for Industry and Food and Drug Administration Staff

March 4, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

During the review of a premarket submission, FDA?s practice has been to communicate with applicants1 through either a formal communication (such as a Major Deficiency Letter or an additional information request issued through a letter, or through phone...

Email to On-line Distributors About Unlawful Marketing of Decorative Contact Lenses

March 4, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The purpose of this Email is to provide you with important information about regulatory requirements and safety concerns associated with the sale, marketing, and distribution of decorative or cosmetic contact lenses in the United States.

ResurFX Fractional Non-Ablative Laser Module to Be Unveiled by Lumenis at the American Academy of Dermatology's Annual Meeting

March 2, 2013 2:30 pm | by The Associated Press | News | Comments

At the 71st Annual Meeting of the American Academy of Dermatology (AAD), the ResurFX* module will be launched for international sales by Lumenis Ltd., the world's largest developer and manufacturer of advanced medical lasers for aesthetic, surgical, and ophthalmic applications.

Are Surgical Robots Worth It?

March 1, 2013 4:47 pm | by Massachusetts Institute of Technology | News | Comments

The FDA looks into the safety of the da Vinci system in light of increased adverse incidents.Surgical robots allow surgeons to perform a variety of less invasive operations because their miniaturized instruments can work through small incisions in the body and are more dexterous than traditional laparoscopic tools (see “The Slow Rise of the Robot Surgeon”). 

Hospira Announces Executive Changes

March 1, 2013 2:32 pm | by Bio-Medicine.Org | News | Comments

LAKE FOREST, Ill. , March 1, 2013 /-  Hospira, Inc. (NYSE: HSP) , the world's leading provider of injectable drugs and infusion technologies, today announced that Royce R. Bedward has been appointed corporate vice president, general counsel and secretary, effective immediately. In his new role, Mr. Bedward will oversee the company's legal department, including litigation...

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