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FDA Grants Prestigious Award to Pediatric Medical Device Consortium Led by Children’s Hospital Los Angeles

October 1, 2013 3:52 pm | by Business Wire | News | Comments

The U.S. Food and Drug Administration’s Office of Orphan Products Development has awarded a grant of up to $1.5 million over five years to the Southern California Center of Technology and Innovation in Pediatrics (CTIP), a consortium established by Children’s Hospital Los Angeles and the University of Southern California (USC) for the development of pediatric medical devices.

The Mount Sinai Hospital to Use Surgical Theater™ Technology for Brain Surgery Cases

October 1, 2013 2:58 pm | by PR Newswire | News | Comments

Surgical Theater, LLC, creator of the Surgical Rehearsal Platform (SRP), has announced the sale of its cutting-edge technology to The Mount Sinai Hospital, making it the first hospital in New York to utilize the SRP for complicated brain tumor and cerebral-vascular cases.

Cost of Robotic vs. Conventional Mitral Valve Repair Surgery Similar

October 1, 2013 10:12 am | by Mayo Clinic | News | Comments

The total hospital cost of mitral valve repair surgery—from the time a patient is admitted to the hospital until release—is similar, whether performed through small port incisions using robotic equipment or via the conventional open-chest method, a Mayo Clinic study of 370 patients found.

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510(k) Clearance for Modular Lateral Interbody Spinal Fusion Device

September 30, 2013 12:22 pm | by PR Web | News | Comments

Vertebral Technologies, Inc. (VTI) is pleased to announce the InterFuse Lateral (InterFuse L™) a modular lateral lumbar interbody fusion device has received 510(k) clearance from the FDA. The InterFuse L™ uses VTI’s patented modular insertion technique to provide a large lateral footprint through a significantly smaller lateral access channel.

Photos of the Day: Funding Regeneration

September 30, 2013 11:47 am | by Rice University | News | Comments

Implants made of biocompatible material will help heal soldiers wounded in the battlefield and civilians as well through research at Rice University and The University of Texas Health Science Center at Houston. The implants hold open a space for a more permanent repair.

DoD Grant Will Push Regenerative Medicine

September 30, 2013 11:34 am | by Rice University | News | Comments

A $75 million Department of Defense grant to improve technologies to treat soldiers injured on the battlefield and advance care for the public will involve bioengineers at Rice University and the University of Texas Health Science Center at Houston (UTHealth).

OmniGuide Surgical Introduces ELEVATE™ ENT System

September 30, 2013 10:43 am | by Business Wire | News | Comments

OmniGuide Surgical, a leading developer of advanced energy surgical products, today announced the market introduction of the ELEVATE ENT System, a new product for ENT surgeons. The latest innovation, utilizing OmniGuide’s proven CO 2 laser technology, will be on display in booth # 2140 at the American Academy of Otolaryngology (AAO) meeting in Vancouver from September 29 through October 2, 2013.

Foundry to Fast Track Nanoimprinted Products

September 30, 2013 9:36 am | by A*STAR IMRE | News | Comments

A new Nanoimprint Foundry, led by Singapore A*STAR's Institute of Materials Research and Engineering (IMRE), will bridge the gap between laboratory-based nanotechnologies and real-world products. The pioneer initiative brings together...

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Skyline Medical's STREAMWAY System Selected as Top Contender in LifeScience Alley's New Technology Showcase

September 27, 2013 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, has been selected as one of only 10 companies in the running for the opportunity to showcase its product to the 2013 LifeScience Alley Conference on November 20, 2013 in Minneapolis, Minn.

OmniGuide raises $15M for BeamPath surgical laser

September 26, 2013 5:25 pm | by Mass Device | News | Comments

OmniGuide Surgical said it raised a $15 million funding round for its BeamPath surgical layer. The Cambridge, Mass.-based medical device company said it plans to use the round to expand BeamPath's footprint in the gynecological market and launch new ear, nose & throat products.

NuVasive Announces First Patients in Japan Treated With Precept Posterior Fixation System

September 26, 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, announced today that the first surgeries were performed in Japan using the Precept® posterior fixation system.

Sector Snap: Mako deal lifts medical device makers

September 25, 2013 2:01 pm | by The Associated Press | News | Comments

Shares of medical device makers rose Wednesday after Stryker Corp. agreed to buy robotic surgery system maker Mako Surgical for $1.41 billion. Stryker will pay $30 per share for Mako, an 86 percent premium based on the stock's latest closing price.

Engineers Develop a Stretchable, Foldable Transparent Electronic Display

September 25, 2013 9:51 am | by University of California - Los Angeles | News | Comments

OLED technology is used today in screens for many smartphones and some televisions. The new ultra-stretchable OLED material developed at UCLA could lead to foldable and expandable screens for new classes of smartphones and other personal electronic devices; new minimally invasive medical tools; and many other applications.

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Stryker Buying Mako Surgical for about $1.41B

September 25, 2013 9:39 am | by The Associated Press | News | Comments

Stryker will spend $1.41 billion to acquire Mako Surgical and all of its robotic assisted surgery technology. The medical device maker will pay $30 per Mako share, an 86 percent premium to its $16.17 closing price Tuesday. The companies put the deal's value at about $1.65 billion.

Wireless Tech Broadens Healthcare Horizons

September 23, 2013 4:59 pm | by Melissa Barnes, Associate Editor, MDT | Articles | Comments

In the field of medical technology, wireless devices are seeing some of the most broad-reaching growth. This is due mostly in part to the wide range of applications that wireless medicine encompasses. Mobi Health News reports that the top ten areas wireless medicine has directly benefited include: Alzheimer’s, asthma, breast cancer, COPD, depression, diabetes, heart failure, hypertension, obesity, and sleep disorders.

FDA expands clearance for Intuitive Surgical's FireFly imaging system

September 23, 2013 2:27 pm | by Mass Device | News | Comments

Intuitive Surgical said the FDA expanded the 510(k) clearance for its FireFly fluorescence imaging system to use during gallbladder surgery using its da Vinci robotic surgery device. The device uses a video camera and fluorescent dye to show blood flow in vessels and tissue, by causing blood to appear green and bloodless tissue as gray, according to a press release.

Worldwide Medtech Sales Forecast to Reach $455 Billion by 2018

September 23, 2013 9:00 am | by Business Wire | News | Comments

The medical device and diagnostics market is set to grow at 4.5 percent per year (CAGR) between 2012 and 2018, totalling $455 billion in 2018, according to the newly-released EvaluateMedTech World Preview 2013, Outlook to 2018: The Future of Medtech report from market intelligence firm Evaluate Ltd.

Teleflex comes under fire after a surgical tool is left in a patient's neck

September 23, 2013 7:29 am | by Mass Device | News | Comments

A patient injured during throat surgery accused medical device maker Teleflex of liability in a personal injury suit after a piece of one of the company's surgical devices broke off and was left in his neck during throat surgery. Patient Michael Kellerman says that Teleflex sold a faulty product...

Integra LifeSciences Announces First Implantation of Titan Reverse Shoulder System

September 23, 2013 4:45 am | by GlobeNewswire | News | Comments

Integra LifeSciences Holdings Corporation today announced the first implantation of its Integra Titan Reverse Shoulder System, in the United States. The system, which is used in the treatment of shoulder replacement surgery, was implanted by William Geissler, M.D., Professor of Orthopaedic Surgery at the University of Mississippi Medical Center.

Vital Access Corp. Announces First U.S. Commercial Implantation Of VWING Vascular Needle Guide

September 20, 2013 4:42 pm | by PR Newswire | News | Comments

Vital Access today announced the first U.S. commercial implantation of their VWING Vascular Needle Guide, in a patient presenting with cannulation challenges and with difficulties in achieving ideal dialysis access due to the depth and tortuosity of their AV fistula.

Hoopes Vision Surgeon First in Utah to Implant New Light Adjustable Artificial Lens

September 20, 2013 4:19 pm | by PR Newswire | News | Comments

On September 4th, Dr. Phillip C. Hoopes, Jr., a surgeon at Hoopes Vision, successfully placed a light adjustable intraocular lens implant in a cataract patient as part of a new FDA clinical study. The surgery, which took place at Hoopes Vision's on-site surgery center, EyeSurg of Utah, was the first of its kind to take place in Utah.

FDA panel approves Ocular Therapeutix' ReSeal, with reservations

September 20, 2013 2:12 pm | by Mass Device | News | Comments

An FDA advisory panel voted yesterday that Ocular Therapeutix's ReSure topical hydrogel post-op sealant is safe, but split on questions of efficacy and whether the benefits of the treatment outweigh its risks. The FDA's Ophthalmic Devices Panel voted 9-1, with 1 abstention, that the ReSure sealant is safe; 5-3, with 3 abstentions, that it is effective; and 5-1, with 5 abstentions, that its benefits outweigh its risks.

Procedure Uses Novel ‘Paper-Clip’ Style Device to Treat High Blood Pressure

September 20, 2013 12:10 pm | by University of Leicester | News | Comments

Researchers at the University of Leicester and Glenfield Hospital have successfully used a novel “paper-clip” sized vascular coupling device to tackle resistant high blood pressure. The operation was carried out on Monday 16 September at Glenfield Hospital by Professor André Ng, Professor of Cardiac Electrophysiology at the University of Leicester and Consultant Cardiologist at Glenfield Hospital.

Sapheon Submits First Module of PMA Application for VenaSeal Sapheon Closure System

September 20, 2013 12:01 am | by The Associated Press | News | Comments

Sapheon Inc. announced today that it submitted the first module of the pre-market approval (PMA) application for the VenaSeal® Sapheon Closure System to the U.S. Food and Drug Administration (FDA). The submission places Sapheon on track for timely FDA review and expected product launch in the first half of 2015.

Sapheon Submits First Module of PMA Application for VenaSeal Sapheon Closure System

September 20, 2013 12:01 am | by Business Wire | News | Comments

Sapheon Inc. announced today that it submitted the first module of the pre-market approval (PMA) application for the VenaSeal® Sapheon Closure System to the U.S. Food and Drug Administration (FDA). The submission places Sapheon on track for timely FDA review and expected product launch in the first half of 2015.

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