Posts tagged: cleared
TMED7 protein can shut down immune system after infection has been cleared
Scientists from Trinity College Dublin have discovered a new 'off switch' in our immune response which could be boosted in diseases caused by over-activation of our immune system, or blocked to improve vaccines.
Bloodstream Malaria Infection Cleared In Mice
University of Iowa researchers and colleagues have discovered how malaria manipulates the immune system to allow the parasite to persist in the bloodstream. By rescuing this immune system pathway, the research team was able to cure mice of bloodstream malaria infections. The findings, which were published in the Advance Online ...
Toshiba debuts 510(k) cleared Aplio 500 ultrasound system
Toshiba America Medical Systems, Inc., launched the Aplio 500 ultrasound system, enabling clinicians to diagnose like never before, using the most advanced visualization tools in the industry.
In Hereditary Parkinson’s Disease Mitochondria Can’t Be Cleared Out When Damaged, Leading To Death Of Neurons
Current thinking about Parkinson's disease is that it's a disorder of mitochondria, the energy-producing organelles inside cells, causing neurons in the brain's substantia nigra to die or become impaired. A study from Children's Hospital Boston now shows that genetic mutations causing a hereditary form of Parkinson's disease cause mitochondria to ...
Abbott’s Genetic Test For Acute Myeloid Leukemia Prognosis Cleared By FDA
Abbott (NYSE: ABT) announced it has received 510(k) clearance from the U.S. Food and Drug Administration for a new in vitro diagnostic test to aid in determining the prognosis of patients with acute myeloid leukemia (AML), one of the most common types of leukemia in older adults. Abbott's Vysis EGR1 ...
Mesoblast cleared to begin first phase 2 clinical trial for wet AMD
Regenerative medicine company Mesoblast Limited (ASX: MSB) today announced that it has received regulatory clearance from the Singapore Health Sciences Authority (HSA) to commence the first Phase 2 trial of its proprietary allogeneic (off-the-shelf) adult stem cell therapy for patients with proliferation of leaky blood vessels in the eyes – ...
ICU Medical introduces FDA cleared Neutron needlefree catheter patency device with constant neutral pressure
ICU Medical, Inc. announced it is launching the Neutron™ needlefree catheter patency device with constant neutral pressure today at the Association for Vascular Access Annual Scientific Meeting in San Jose, CA.
Blood Test And Algorithm For Ovarian Cancer Developed By Oncologist, Cleared By FDA
Approval last week by U.S. Food and Drug Administration (FDA) clears the path for nationwide use of tools that show the greatest specificity in estimating the risk of ovarian cancer in women with a pelvic mass. The FDA granted 510(k) clearance for marketing and use of a combination of blood ...
Breakthrough CardioHealth(R) Station Cleared By FDA To Take Center Stage At The Annual Scientific Sessions Of The American College Of Cardiology 2011
CardioNexus Corporation an affiliated company of Panasonic Healthcare Co. Ltd., will introduce Panasonic CardioHealth® Station at the 2011 Annual Scientific Sessions of the American College of Cardiology. The device, which has just received clearance from the U.S. Food & Drug Administration, is an automated and portable cardiovascular imaging device which ...
Artimplant: Artelon(R) CMC Soft Cleared For Marketing In Europe
In collaboration with Small Bone Innovations (SBi), Artimplant has developed a new product in the Artelon® Spacer range with a similar user-friendly textile design to Artelon® Tissue Reinforcement (ATR). The product, Artelon® CMC Soft, has been granted CE-approval by the certification body Lloyd's and has thus been granted clearance for ...
Medtronic Facilities Cleared By FDA; MRI Safe Pacemakers Ready
Medtronic, manufacturer of the recently approved Revo MRI safe pacemaker, has just been cleared by the U.S. Food and Drug Administration after receiving a warning letter following an August 2009 inspection of the company's Mounds View facility, which serves as the headquarters of the Cardiac Rhythm Disease Management business. In ...