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.
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.
Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, among other core businesses, announced today the commercial availability of its 510(k) cleared QuickClip Pro™ hemostasis clip designed for bleed control and defect closure during GI endoscopy procedures. Unlike prior generation clip fixing devices, the QuickClip Pro combines both superior rotational control to ensure precise placement along with the addition of open and close capabilities for easy repositioning.
CompactCath, Inc., a medical device company committed to improving the quality of life for people with bladder conditions announced today that it received FDA 510(k) Clearance to market its intermittent urinary catheter. This innovative compact, pre-lubricated and easy-to-use intermittent urinary catheter will enable people to catheterize regularly while maintaining their privacy and discreetness. The modern packaging and disposal mechanism eliminate the inconvenience of carrying, concealing, and disposing of traditional catheters. CompactCath's FDA clearance is a big step forward for users looking for a modern, friendly and reliable catheter alternative.
Cepheid today announced the release of Xpert® TV, an on-demand molecular test for rapid, accurate and reproducible identification of Trichomoniasis (TV) infections in both males and females. The test will be marketed as a CE-IVD product under the European Directive on In Vitro Diagnostic Medical Devices, bringing the total number of CE-IVD tests available to nineteen. Xpert TV runs on Cepheid's GeneXpert® System, the world's leading molecular diagnostic platform with more than 7,000 systems installed worldwide.
Ortho Development® Corporation (ODEV) has received FDA clearance for the Alpine™ Hip Stem, the latest addition to its growing hip replacement product line. The Alpine Hip Stem is intended for use in total hip arthroplasty and hemiarthroplasty procedures. Alpine was developed based on the clinically-proven, conical tapered hip stem philosophy.
ResMed has introduced the Astral™ 100 and Astral™ 150 devices in the United States. The Astral platform is ResMed's new generation of portable, lightweight, and user-friendly life support ventilators. The new Astral life support ventilators offer unparalleled mobility and ease of use for patients suffering from neuromuscular disease, chronic obstructive pulmonary disease (COPD), and other adult and childhood respiratory disorders. The U.S. launch comes on the heels of Astral's successful introduction to European and select Asia-Pacific markets earlier this year.
InnoPharma, Inc. today announced the approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for decitabine for injection, a generic version of Eisai Inc.'s DACOGEN®. InnoPharma developed the generic formulation of decitabine for injection and entered into an agreement with Sandoz, Inc., pursuant to which Sandoz will sell, market and distribute decitabine for injection in the United States. According to IMS data, aggregate U.S. sales of DACOGEN were approximately $251 million for the twelve months ending in April 2014.
Royal Philips (NYSE: PHG, AEX: PHIA) today announced the launch of Affiniti, a new ultrasound system designed to enable global hospitals and health systems to overcome the demands of increasing patient volumes and cost pressures. Making its debut at the European Society of Cardiology (ESC) Congress 2014 in Barcelona this week, Affiniti provides innovative technology to help radiology/ultrasound departments facing more patients with fewer resources deliver high quality patient care.
Nonin Medical, Inc., the inventor of finger pulse oximetry and a leader in noninvasive medical monitoring, today announced that the Food and Drug Administration (FDA) has cleared the Nonin Model 3231 OEM/eHealth finger pulse oximeter for use in the United States. The finger pulse oximeter plugs into a telemedicine hub or kiosk through a USB connector and measures oxygen saturation and pulse rate in pediatric to adult patients. The Model 3231 received EU certification last year.