In March 2014, Siemens officially presented Unity 3, the latest version of their diagnostic and fitting system for hearing care professionals. Presented at at the American Academy of Audiology's AudiologyNOW! conference in Orlando, Florida, The system combines all of the hearing care professional’s work steps in a single, time-saving process: from computer-assisted hearing ability measurement to the individual fitting of the selected hearing aids.
SynCardia Systems, Inc., which manufactures the world's only FDA (United States), Health Canada and CE (Europe)-approved Total Artificial Heart, has won the 2014 New Economy Award for Best Medical Device Company. The New Economy, a London-based quarterly publication that covers topics of innovation worldwide, announced the award to SynCardia in its recently released autumn 2014 issue, which also is available online. A listing of all winners by category will appear in its winter edition.
VisionCare Ophthalmic Technologies, Inc., a developer of advanced visual prosthetic devices for the treatment of age-related macular degeneration (AMD), today announced the U.S. Food and Drug Administration approved the Implantable Miniature Telescope for use in patients living with bilateral end-stage age-related macular degeneration who are age 65 or older. The telescope implant is the only FDA approved surgical device for end-stage AMD and is Medicare eligible.
Cynosure® recently announced that PicoSure®, the world's most advanced laser technology for tattoo removal, benign pigmented lesions and acne scars, is now FDA-cleared for the treatment of fine lines and wrinkles. New results from PicoSure clinical studies show a dramatic improvement in pigment and wrinkles:
Dale Medical Products Launches IV-ARMOR™, An Innovative Solution To Reducing Problematic IV Occlusions
Dale Medical Products is launching an innovative solution to a longstanding clinical challenge: IV occlusions. Until now, patients requiring IV lines had to either limit their mobility or risk having an occlusion due to kinked tubing. Dale's new IV-ARMOR™, a flexible, protective overlay, maximizes continuous IV flow even during patient movement. Dale's IV-ARMOR helps maintain IV patency without the need for a stiff immobilizing device. The protective overlay covers the IV site comfortably, allowing patients greater freedom to move naturally and clinicians the ability to access the site easily for inspection.
RDT is pleased to announce that, following CE and other market approvals, it has received 510k clearance by the US Food and Drug Administration for the addition to the Tempus Pro medical monitor of: 12 Lead ECG recording interpretation, real-time arrhythmia detection, ST and QT monitoring and alarming (unique to a fully-featured pre-hospital transport monitor) an additional two channels of invasive blood pressure (four in total), Masimo rainbow® SET® co-oximetry, video laryngoscope and ultrasound.
Pathology Associates Medical Laboratories, a leading healthcare solutions provider and one of the nation's top reference laboratories, recently unveiled their website for Cinch™, the company's new consumer-based product line that empowers individuals to reveal their health through easy access to laboratory testing and information. With more consumers looking for ways to proactively manage their health, many have turned to the internet for help in accessing medical resources to help them make smart decisions. Cinch provides these consumers a simple solution to providing laboratory test ordering and resulting online.
ScanMed of Resonance Innovations LLC is proud to introduce a world's first to the MRI market: The PROCURETM Coil. The latest product in ScanMed's Game-Changer Coil Line is the The PROCURE™ Coil (Prostate, Rectum, Ovaries, Cervix, Uterus, Reproductive). The PROCURETM features a first-of-a-kind, lightweight SemiFlexTM design that facilitates effortless and accurate positioning. Similar to wearing a diaper, this dedicated MRI coil positions the multiple antenna elements as close as possible to the target anatomies regardless of patient size. The enclosure for the antenna set is made of flexible liquid impermeable, biocompatible materials.
ACIST Medical Systems, Inc., a Bracco Group company, pioneer and global market leader of advanced imaging modalities for cardiology, showcased the first-ever HDi™ High-Definition Intravascular Ultrasound System in two live cases at the Transcatheter Cardiovascular Therapeutics meeting in Washington, D.C. The cases were presented from Medstar Washington Hospital Center (Washington, D.C.) and New York-Presbyterian Hospital/Columbia University Medical Center (New York, NY). The HDi features an intuitive touch screen with 60MHz image quality, high-speed pullback, a deliverable Kodama® HD-IVUS catheter and the ACIST HDi console. HD-IVUS is a reinvention of intravascular imaging.
Quantel Medical today announced CE Mark approval for its Vitra™ PDT photodynamic therapy laser platform, for the treatment of polypoidal choroidal vasculopathy (PCV) and central serous retinopathy (CSR). Quantel, the sole manufacturer of this laser technology, plans to begin commercializing the laser platform immediately in countries requiring CE registration.
Denton Vacuum, LLC, a leading manufacturer of thin film technology products, has introduced Vitua, the first automated TEM sample preparation system specifically designed and characterized for high resolution rotary shadow casting of large organic molecules.TEM organic molecule imaging presents unique challenges. Small samples, such as DNA or complex proteins, are difficult to image using traditional staining techniques. Moreover, TEM processing inevitably degrades stained samples making follow-up characterization impossible.
Livongo Health, has announced the availability of Livongo for Diabetes, its new consumer digital health platform that provides real-time information, personalized tools and a connected support network to empower people with diabetes to live better. Diabetes is a 24/7 disease that takes significant effort to manage and there is no right answer for everyone. It requires a simple approach that focuses on the individual. Livongo for Diabetes translates the unique story each person's body tells into actionable information that empowers people managing a chronic condition to live better.
Leica Biosystems, a global leader in automation and workflow solutions for anatomic pathology, announced the launch of Aperio PeerReview, a complete digital pathology software solution for toxicological pathologists conducting peer review studies in pre-clinical trials. With barcode-driven automated integration of LIMS data and images, combined with customized viewing functionality, specific for toxicological pathology, Aperio PeerReview helps to reduce costs and improve efficiency in pre-clinical testing.
Astute Medical, Inc. announced today that it has received 510(k) clearance through the Food and Drug Administration's (FDA's) de novo classification process for its first biomarker-based immunoassay known as the NephroCheck® Test System, clearing the path to commence sales in the coming weeks.