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Endologix wins IDE approval for aneurysm sealing system

January 3, 2014 3:17 pm | by Mass Device | News | Comments

Endologix said it won FDA Investigational Device Exemption for its Nellix endovascular aneurysm sealing system, paving the way for a U.S. clinical trial. The EVAS Forward-IDE study is expected to enroll 180 patients at 30 sites throughout...

Robotic surgery complaints become FDA complaints

January 2, 2014 5:05 pm | by Mass Device | News | Comments

As patient complaints mount in lawsuits against Intuitive Surgical and its da Vinci robot-assisted surgical platform, physicians and researchers are shifting some of the blame to the FDA's postmarket surveillance systems as an inadequate...

Novel Noninvasive Therapy Prevents Breast Cancer Formation in Mice

January 2, 2014 10:03 am | by Wyss Institute for Biologically Inspired Engineering at Harvard | News | Comments

A novel breast-cancer therapy that partially reverses the cancerous state in cultured breast tumor cells and prevents cancer development in mice, could one day provide a new way to treat early stages of the disease without resorting to surgery...

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AtriCure Completes Acquisition of Estech

January 2, 2014 9:00 am | by Business Wire | News | Comments

AtriCure, Inc., a leading Atrial Fibrillation medical device provider, today announced the completion of the previously announced acquisition of Endoscopic Technologies, Inc. d/b/a Estech. Estech develops and markets a portfolio of innovative...

Skyline Medical's STREAMWAY System Provides New Option for Radiology

January 2, 2014 8:30 am | by PR Newswire | News | Comments

Skyline Medical Inc., formerly BioDrain Medical, producer of the FDA-approved STREAMWAY System for automated, direct-to-drain surgical fluid disposal, formally introduced its flagship system to radiologists, radiology administrators and...

CSA Medical closes $16M financing round

December 31, 2013 10:59 am | by Mass Device | News | Comments

CSA Medical said it raised $16 million, closing a series C financing round led by Ascension Ventures. The Baltimore-based medical device company manufactures advanced spray cryotherapy technology that flash freezes unwanted tissue inside the...

Stryker Announces Definitive Agreement to Acquire Patient Safety Technologies, Inc. for $120 Million

December 31, 2013 9:06 am | by The Associated Press | News | Comments

Stryker Corporation announced today a definitive agreement to acquire Patient Safety Technologies, Inc. for $2.22 per share, with an aggregate purchase price of $120 million. Patient Safety Technologies conducts its business through its wholly...

Endologix Receives IDE Approval for the Nellix EndoVascular Aneurysm Sealing System

December 30, 2013 10:04 am | by Globe Newswire | News | Comments

Endologix, Inc., developer and marketer of innovative treatments for aortic disorders, announced today that it has received Investigational Device Exemption approval from the United States Food and Drug Administration to begin a pivotal...

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Symmetry Medical Amends Credit Agreement and Eliminates Mezzanine Debt

December 27, 2013 4:45 pm | by Globe Newswire | News | Comments

Symmetry Medical Inc., a leading global source of innovative medical device solutions, including surgical instruments, orthopedic implants, and sterilization cases and trays, announced today that it has amended its credit agreement, enabling...

Research to Revolutionize Indications for Knee Surgery

December 27, 2013 9:22 am | by University of Helsinki | News | Comments

The Finnish Degenerative Meniscal Lesion Study compared surgical treatment of degenerative meniscal tears to placebo surgery. A year after the procedure the study participants, both those in the group who underwent surgery and the ones in...

California Family Celebrates Three Heart Transplants

December 24, 2013 12:42 pm | by Gillian Flaccus, Associated Press | News | Comments

Deanna Kremis remembers the exhilarating day her young sons first had the energy to race each other up a flight of stairs. The brothers, then ages 7 and 10, could barely walk before having heart transplants just a month apart. As they flew...

Johns Hopkins Review Throws Doubt on Wound Care Treatment

December 24, 2013 12:06 pm | by Johns Hopkins Medicine | News | Comments

A systematic review of 66 research papers focused on the treatment of skin ulcers suggests that most are so technically flawed that their results are unreliable. And even of those that pass muster, there is only weak evidence that some... 

$3.5M Awarded for Commercialization of Medical Devices for Children

December 23, 2013 9:09 am | by Georgia Tech | News | Comments

The Atlantic Pediatric Device Consortium (APDC) has been awarded $3.5 million over five years by the U.S. Food and Drug Administration to assist scientists, clinicians and entrepreneurs in bringing medical devices for children to the market...

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NuVasive(R) Manufacturing, LLC., Expands U.S. Workforce to Drive Speed of Innovation(R)

December 20, 2013 4:30 pm | by The Associated Press | News | Comments

NuVasive, Inc., a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, announced today that NuVasive Manufacturing, LLC., (NML) will expand its workforce by more than 25 percent...

Study Shows Robotic-Assisted Prostate Surgery Reduces Hospital Readmission and Complication Rates Compared to Open Surgery

December 19, 2013 8:45 pm | by GlobeNewswire | News | Comments

A national, multi-institutional database study found readmission and complication rates were significantly lower for robotic-assisted prostate surgery than for open prostate surgery. The full study results were published in the November 19...

Newly Insured Bring New Opportunities and Challenges

December 19, 2013 4:12 pm | by Michael Frank, Healthcare Industry Expert, PA Consulting Group | Blogs | Comments

The medical device sector has emerged from the winter of the great recession into a much more price sensitive market. Pressure is mounting to reduce cost of devices where there are cheaper alternatives. While the 2.3% medical device excise...

The Pulse: Prosthetics with Feeling & One Hour AIDS Detection

December 19, 2013 4:05 pm | by Eric Sorensen, Coordinator of Multimedia Development | Videos | Comments

This week on The Pulse, we are giving feeling to prosthetics, detecting AIDS in an hour, improving inhaler technology, and stopping hemorrhaging in trauma patients. This episode features…          

World's First Implant After FDA Approval for Groundbreaking Epilepsy Treatment

December 19, 2013 12:39 pm | by The Associated Press | News | Comments

On Dec. 18, Keck Medicine of USC became the world's first medical center to implant a responsive brain device newly approved by the Food and Drug Administration (FDA) to treat epilepsy, with potential to help millions of people worldwide...

ZipLine® Medical Clinical Study Data Presented at Mt. Sinai “Winter Symposium”: ZipLine Produces Suture-Like Outcomes with Significant Surgical Time-Savings

December 19, 2013 11:29 am | by Business Wire | News | Comments

Preliminary clinical study results from a randomized, controlled, prospective clinical study comparing the ZipLine Surgical Skin Closure to traditional stitches for skin cancer excision were presented at the 16th Annual Mount Sinai Winter Symposium...

First Cancer Operation Room with a Navigator Is Created

December 19, 2013 10:59 am | by Universidad Carlos III de Madrid | News | Comments

A team of researchers from Gregorio Marañón Hospital, the company GMV and the Universidad Carlos III de Madrid (UC3M) have started the first cancer operation room with a navigator. This image-guided system will allow for increased intraoperative...

Photo of the Day: Newly Designed Cancer OR

December 19, 2013 10:57 am | by Universidad Carlos III de Madrid | News | Comments

The system, presented at Gregorio Marañón Hospital, permits real-time interaction with the body of the patient (with its different tissues and cancer) as well as the radiotherapy applicator used to radiate the area affected by the tumor. This...

FDA: Intuitive Surgical recalls are Class II

December 18, 2013 4:38 pm | by Mass Device | News | Comments

A pair of recalls affecting more than 110,000 components of Intuitive Surgical's flagship da Vinci surgical robot pose only a slight risk of serious consequences, the FDA said this week. Intuitive notified customers Nov. 15 of the potential...

RapidFIRE: Squishy Skulls for Simulating Brain Surgery

December 18, 2013 10:32 am | by Alex Shanahan, Multimedia Production Specialist | Videos | Comments

Researchers at the University of Malaya, in Malaysia, have developed a unique, multi-material model to help train and better the practice of novice neurosurgeons. With two components, the 3D-printed skull gives trainees...    

Encision Announces New President and CEO

December 18, 2013 7:00 am | by The Associated Press | News | Comments

Encision Inc., a medical device company owning patented surgical technology that prevents stray electrosurgical burns in minimally invasive surgery, today announced the appointment of Greg Trudel as its new President and CEO. A proven manager...

NuVasive(R) Announces the U.S. Launch of ALIF ACR(TM)

December 17, 2013 8:39 am | by The Associated Press | News | Comments

NuVasive, Inc., a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, is excited to announce the United States launch of ALIF ACR™ (Anterior Lumbar Interbody Fusion - Anterior...

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