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Abiomed Announces Revenue of $38.3 Million, Up 19% and Record Impella Patient Usage, Up 26%

February 6, 2013 3:44 am | by GlobeNewswire | News | Comments

Abiomed, Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support technologies, today reported third quarter fiscal 2013 revenue of $38.3 million, up 19% compared to revenue of $32.2 million in the same period of fiscal 2012, on record quarterly patient usage, up 26% compared to the same period of fiscal 2012.

ZOLL Receives Shonin Approval from Japan to Market Intravascular Temperature Management Technology

February 6, 2013 12:05 am | by The Associated Press | News | Comments

CHELMSFORD, Mass.--(BUSINESS WIRE)--Feb 6, 2013--ZOLL Medical Corporation, a manufacturer of medical devices and related software solutions, has received Shonin approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) to enter the Japanese market with its Intravascular Temperature...

Webinar - What a UDI System can do for Patients and Consumers

February 6, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

Successful UDI implementation offers a number of potential benefits for patients and consumers, including faster detection of safety concerns associated with specific devices, more efficient communication between providers and patients regarding...

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Class II Special Controls Guideline: Temporary Mandibular Condyle Reconstruction Plate

February 6, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The FDA has developed this draft guideline as the special controls to support the reclassification of the temporary mandibular condyle reconstruction plate (TMCRP) from class III to class II (special controls), which is being issued as a proposed order..

Kips Bay Medical Announces the First U.S. Implant in the eMESH I Clinical Feasibility Trial

February 5, 2013 4:50 pm | by The Associated Press | News | Comments

MINNEAPOLIS--(BUSINESS WIRE)--Feb 5, 2013--Manny Villafaña, Chairman and CEO of Kips Bay Medical Inc. (NASDAQ:KIPS) announced that on February 5, 2013, the first U.S. patient was implanted with the eSVS ® Mesh at the Northeast Georgia Heart Center in Gainesville, Georgia. This implant was...

House majority leader Eric Cantor decries the medical device tax

February 5, 2013 4:27 pm | by Mass Device | News | Comments

House majority leader Eric Cantor's (R-Va.) comments on the medical device tax remind that the fight for repeal isn't over. House majority leader Eric Cantor (R-Va.) hasn't forgotten about the the medical device tax, a measure he once called a "draconian" burden on the U.S. medtech industry.

Thoratec Reports Fourth Quarter And Full Year Fiscal 2012 Financial Results

February 5, 2013 4:02 pm | by PR Newswire | News | Comments

PLEASANTON, Calif., Feb. 5, 2013 /PRNewswire/ -- Thoratec Corporation (NASDAQ: THOR), a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, today reported its financial results for the fourth quarter of 2012. "Thoratec...

Viracor-IBT Laboratories Acquires Assets of Cylex

February 5, 2013 3:54 pm | by PR Newswire | News | Comments

LEE'S SUMMIT, Mo., Feb. 5, 2013 /PRNewswire/ -- Viracor-IBT Laboratories, Inc. announced today that it has signed a definitive agreement to purchase the assets of Cylex™, Inc., a global life sciences company focused on the development, manufacturing and...

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GE Healthcare and NFL team up to fight sports-related brain injuries

February 5, 2013 3:20 pm | by Mass Device | News | Comments

Health technology giant GE Healthcare joins forces with the National Football Assn. to develop concussion detection systems and brain protection technologies to make football a safer sport. Technology giant GE (NYSE:GE) announced a new partnership with the National Football Assn. in pursuit of better concussion detection technology and materials that may better protect athletes from traumatic brain injuries.

William Blair boosts NxStage stake by 20%

February 5, 2013 2:59 pm | by Mass Device | News | Comments

William Blair & Co. added 20% to its stake in medical device company NxStage Medical, which makes home hemodialysis equipment. William Blair & Co. added 20% to its holdings in NxStage Medical (NSDQ:NXTM) last year, according to regulatory filings. The Chicago-based investment bank owned more than 3.8 million NXTM shares as of Dec. 31, 2012, up 19.5%...

New Modeling Approach Transforms Imaging Technologies

February 5, 2013 2:44 pm | by Purdue University | News | Comments

Researchers are improving the performance of technologies ranging from medical CT scanners to digital cameras using a system of models to extract specific information from huge collections of data and then reconstructing images like a jigsaw puzzle. The new approach is called model-based iterative reconstruction, or MBIR.

MicroRNA Molecule May Serve as Biomarker, Target for Brain Metastases in Breast Cancer Patients

February 5, 2013 1:00 pm | by AACR | News | Comments

Researchers have identified two molecules that could potentially serve as biomarkers in predicting brain metastases in patients with breast cancer, according to data published in Cancer Research, a publication of the American Association for Cancer Research. Currently, most deaths from breast cancer are a result of metastatic disease.

FDA Clears Sculptor Robotic Guidance Arm for Unicompartmental Knee Replacement Surgery

February 5, 2013 12:11 pm | by Stanmore Implants | News | Comments

Stanmore Implants, specialists in the design and manufacture of patient specific and modular orthopedic implants, announced today that it has received 510(k) clearance from the US Food and Drug Administration to market its Sculptor Robotic Guidance Arm™ for precision implant placement in unicompartmental knee surgery, also known as partial knee resurfacing.

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Conceptus Announces Enrollment of First Patient in European Clinical Trial for Next Generation Essure

February 5, 2013 11:34 am | by GlobeNewswire | News | Comments

Conceptus, Inc., developer of the Essure® procedure, the leading surgery-free permanent birth control method, announced today that it has initiated enrollment in its European clinical study designed to support the company's CE Mark application for its next generation Essure device.

Comparative Effectiveness Program Accepting Suppliers to Join Hospitals in Improving Healthcare Safety and Efficiency

February 5, 2013 10:05 am | by The Associated Press | News | Comments

CHARLOTTE, N.C.--(BUSINESS WIRE)--Feb 5, 2013--The Premier healthcare alliance is accepting applications for the fourth wave of its QUEST® Comparative Effectiveness & Innovation Program ( QCEIP ), a voluntary program designed to evaluate products and clinical intervention in real-world...

Roche's ACCU-CHEK Blood Glucose Meters Rank Highest in Overall Satisfaction in Study

February 5, 2013 10:00 am | by PR Newswire | News | Comments

INDIANAPOLIS, Feb. 5, 2013 /PRNewswire/ -- Adults living with diabetes in the United States reported highest satisfaction using Roche Diabetes Care's ACCU-CHEK products compared with other blood glucose meter manufacturers, according to the inaugural J.D. Power and Associates 2012...

Cook Medical Study of Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions Exceeds 50% Enrollment

February 5, 2013 9:03 am | by The Associated Press | News | Comments

BLOOMINGTON, Ind.--(BUSINESS WIRE)--Feb 5, 2013--With more than 100 patients enrolled, Cook Medical has exceeded 50 percent enrollment in the Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions trial. The first-of-its-kind, prospective, multicenter study is evaluating the retrograde...

T2 Biosystems Announces Patent Covering T2Hemostasis

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

LEXINGTON, Mass.--(BUSINESS WIRE)--Feb 5, 2013--T2 Biosystems, a company developing direct detection products enabling superior diagnostics, today announced the U.S. Patent and Trademark Office has issued patent 8,344,731 (the ‘731 patent), “NMR device for the detection of analytes”. The patent...

The Better Way Back(R), a NuVasive(R) Patient Education Program, Reaches 1,000 Patient Ambassadors

February 5, 2013 8:30 am | by The Associated Press | News | Comments

NuVasive, Inc. (NASDAQ: NUVA), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, is pleased to announce that The Better Way Back®, a NuVasive supported patient education program, has reached over 1,000 active...

Aethlon Medical Note: Thank You Shareholders

February 5, 2013 8:05 am | by PR Newswire | News | Comments

SAN DIEGO, Feb. 5, 2013 /PRNewswire/ -- Aethlon Medical, Inc. (OTCQB: AEMD), today released the following note authored by its Chairman and CEO, Jim Joyce. In our quest to innovate life-saving therapeutics, we have persevered through untold challenges to create a single...

Awarepoint Launches New Bed & Bay Sensor After Successful Beta Implementation at Christiana Care Health System

February 5, 2013 8:00 am | by The Associated Press | News | Comments

Awarepoint Corporation, the largest real-time location system (RTLS) corporation dedicated exclusively to healthcare, announces the launch of its new Bed and Bay Sensor that enables precise tracking of mobile equipment and patient and caregiver interactions in locations with...

MGC Diagnostics Corporation Announces National Jewish Health Selects the Company as Preferred Provider for Cardiopulmonary Diagnostic Instrumentation

February 5, 2013 8:00 am | by PR Newswire | News | Comments

SAINT PAUL, Minn., Feb. 5, 2013 /PRNewswire/ -- MGC Diagnostics Corporation (NASDAQ: MGCD) (formerly Angeion Corporation), a global medical technology company, today announced that National Jewish Health has selected MGC Diagnostics as its preferred provider of cardiopulmonary...

Breg Introduces Post-operative Knee Brace and Other New Orthopedic Products

February 5, 2013 8:00 am | by PR Newswire | News | Comments

CARLSBAD, Calif., Feb. 5, 2013 /PRNewswire/ -- Breg, Inc., a premier provider of sports medicine products and services, announced today four new products that will advance the orthopedic practice. The highlight of the new introduction is a next generation post-operative knee...

Oticon Medical Certified as Medicare Durable Medical Equipment Supplier

February 5, 2013 7:30 am | by The Associated Press | News | Comments

SOMERSET, N.J.--(BUSINESS WIRE)--Feb 5, 2013--Oticon Medical today announced that the company has obtained accreditation as a Medicare Durable Medical Equipment Supplier from the Centers for Medicare & Medicaid Services (CMS). Oticon Medical is now accredited to bill the Medicare Part B...

Pacemaker Payment Plans, Courtesy of Medtronic

February 5, 2013 7:29 am | by Mass Device | News | Comments

Medtronic offers patients in India the option to pay off a pricey cardiac implants in installments. Medtronic's (NYSE:MDT) India division is offering patients an "easy monthly installment" plan to help families cope with the high cost of cardiac implants. The EMI program is available in 60 hospitals in 18 cities and applies to a handful of medical devices...

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