Teleflex Incorporated (NYSE: TFX), a leading global provider of medical devices for critical care and surgery, has announced that its subsidiary Hotspur Technologies, Inc., which Teleflex acquired in June 2012, completed CE marking requirements to market the company’s Arrow ® GPSCath ® Balloon Dilatation Catheters to the European Union.
ZELTIQ® Aesthetics, Inc. (Nasdaq:ZLTQ), a medical technology company focused on developing and commercializing products utilizing its proprietary controlled-cooling technology platform, today announced that it prevailed in two major legal cases.
Covidien Nellcor Pulse Oximeters Receive FDA 510(k) Clearance with Labeling for Use in Newborn Screening for Critical Congenital Heart DiseaseMay 28, 2013 12:35 pm | by Covidien | Comments
Covidien’s new CCHD labeling was introduced as part of the FDA 510(k)-cleared labeling for motion tolerant Nellcor pulse oximeters. In 2011, the U.S. Department of Health and Human Services added CCHD screening to the Federal Recommended Uniform Screening Panel Guidelines.
The parents of a 10-year-old Pennsylvania girl who has been waiting for a lung transplant for a year and a half are calling for a change in the policy governing organ transplants that they say has prevented their increasingly sick daughter from getting life-saving surgery.
The Food and Drug Administration said Thursday it approved a new blood test from Roche to help doctors diagnose diabetes. The Cobas Integra 800 is a blood test that measures a patient's average blood sugar level over the previous three months. In particular, the test measures an oxygen-carrying blood component known as hemoglobin.
Obese mothers tend to have kids who become obese. Now provocative research suggests weight-loss surgery may help break that unhealthy cycle in an unexpected way — by affecting how their children's genes behave. In a first-of-a-kind study, Canadian researchers tested children born to obese women, plus their brothers and sisters who were conceived after the mother had obesity surgery.
Canadian drugmaker Valeant Pharmaceuticals has agreed to pay $8.7 billion to buy Bausch + Lomb, one of the world's best-known makers of contact lenses, in a massive expansion of Valeant's smaller ophthalmology business. Valeant said Monday that the cash deal will help it capitalize on increasing demand for contact lenses and other products because of aging populations, growing demand in emerging markets and increasing rates of diabetes.
New research is challenging medical guidelines that say people with a heart-zapping device in their chests should avoid intense sports like basketball and soccer in favor of golf or bowling. Lots of patients ignore that take-it-easy advice and stay in the game, and Monday's findings suggest vigorous exercise may be safe for many of them after all.
Although colonoscopy exams prevent many colon cancer deathsand are considered the most sensitive method for detecting colorectal cancers, the procedure is not completely effective in preventing cancer cases. EndoChoice has unveiled research that shows that its new Fuse system significantly improves the accuracy of this procedure and greatly reduces the number of adenomas missed by colonoscopists.
GE Healthcare (NYSE: GE) has introduced MAVRIC SL, a novel magnetic resonance (MR) imaging technique designed to address the growing clinical need to more accurately image soft tissue and bone in patients with MR Conditional-labeled implants, such as joint replacements and other instrumentation.
Human fetal stem cell grafts improve both motor and sensory functions in rats suffering from a spinal cord injury, according to research published this week in BioMed Central's open access journal Stem Cell Research and Therapy. This cell replacement therapy also improves the structural integrity of the spine, providing a functional relay through the injury site.
More than any other group, the high-tech industry got big wins in an immigration bill approved by the Senate Judiciary Committee last week, thanks to a concerted lobbying effort, an ideally positioned Senate ally and relatively weak opposition. The result amounted to a bonanza for the industry.
Aptus Endosystems, Inc. announced today that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its 28mm Tip Reach Heli-FX™ Guide. A line extension of the original Heli-FX System, the new product enhances treatment of wide neck abdominal aortic aneurysms (AAA).
OrSense Non Invasive Hemoglobin Monitor Shown Safe and Accurate for Pre-Donation Screening in Blood BanksMay 28, 2013 7:00 am | by Business Wire | Comments
OrSense Ltd., developer of monitors for non-invasive measurements of various blood parameters, announced today that its non-invasive Hemoglobin (Hb) NBM-200 monitor was the topic of multiple recent studies highlighting the clinical value of the device.
Boston Scientific Corporation has received CE Mark approval for use of the GUIDE™ DBS System, the world's first deep brain stimulation (DBS) visualization system. GUIDE DBS provides clinicians with 3D visualization information that simulates stimulation output, which may reduce programming time and enable more precise targeting of therapy.