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.
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.
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.
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.
PDI Prevantics® Skin Antiseptics: Proven to Help Facilities Reduce CLABSI Rates and Associated Costs
PDI, a leader in infection prevention products and solutions, continues to reinforce the importance of a complete infection prevention program for skin antisepsis. Prevantics® products are the first and only 3.15% Chlorhexidine Gluconate (w/v) and 70% Isopropyl Alcohol (v/v) formula which has been proven to deliver seven days of continued antimicrobial activity, aligning with dressing change protocols at many healthcare facilities.
The crowdfunding campaign for PosturePulse, a biofeedback posture-improving belt, is in full effect on the popular crowdfunding platform Kickstarter. Backers have already pledged over $7,700 to show their support for the biofeedback belt. The $75,000 funding goal for the campaign was set in order to mass-produce and distribute the product. PosturePulse is a small device worn on the lower back that silently vibrates if the wearer slouches for more than seven seconds. Using an accelerometer, the same kind of motion-accurate chip used in gaming controllers and cell phones, PosturePulse takes several measurements per second to determine the precise angle of the wearer's back. When continuously worn, this feedback belt coaches users to always sit or stand upright.
Philips Lifeline introduces response app to connect seniors with access to help in the event of an emergency
Royal Philips have introduced the Philips Lifeline response app, the company's latest innovation designed to empower seniors to live independently while aging well. Offering a direct connection to the company's leading U.S.-based call center, the mobile app gives seniors 24-hour access to emergency assistance. In a recent survey by Philips and the Global Social Enterprise Initiative (GSEI) at Georgetown University's McDonough School of Business, 96 percent of senior respondents said it is important to be as independent as possible as they get older. The Philips Lifeline response app for Android and iOS smartphones enables them to take peace of mind with them when they are on the go.
AliveCor Receives First FDA Clearance to Detect a Serious Heart Condition in an ECG on a Mobile Device
AliveCor, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted the company clearance for its algorithm to detect atrial fibrillation (AFib), the most common form of cardiac arrhythmia. AliveCor's automated analysis process (algorithm) instantly detects if patients are experiencing AFib through real-time electrocardiogram (ECG) recordings taken on the mobile phone based AliveCor® Heart Monitor, so physicians can intervene before potentially life-threatening conditions, like strokes, occur. Through AliveCor's ECG analysis service, patients can confirm their results with a U.S. board-certified cardiologist or a personal physician.
Emergency Medical Products (EMP), a leading distributor of emergency medical equipment and supplies, announced the addition of the Guardian Angel Personal Safety Device to its growing line of medical supplies and equipment. Guardian Angel is a wearable (approximately 6 oz.) lighted device, designed to provide immediate visibility and recognition for emergency responders of all kinds.
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