Ocular Therapeutix, the latest endeavor of serial entrepreneur Amar Sawhney, released positive findings from a Phase II study of its absorbable intracanalicular plug, designed to provide long-term drug therapy following eye surgery. Ocular Therapeutix enrolled 60 cataract surgery patients in a placebo-controlled, randomized clinical trial...
FDA Grants Prestigious Award to Pediatric Medical Device Consortium Led by Children’s Hospital Los AngelesOctober 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.
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.
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.
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.
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.
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, 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.
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...
Skyline Medical's STREAMWAY System Selected as Top Contender in LifeScience Alley's New Technology ShowcaseSeptember 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 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, 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.
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.
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.
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.
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.
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.
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.
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 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 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.
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.
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.
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 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.