Tag: FDA

Upvote Story 9
Sepsis is deadly, it’s expensive, and there are abundant initiatives underway that could lead to earlier detection, lowering costs, and saving lives. In May 2016, the Healthcare Cost and Utilization Project and the Agency for Healthcare Research and Quality released a report about the impact of sepsis on U.S. inpatient hospital costs. The study, which analyzed billings from 2013, revealed the following: Sepsis accounts for... Read More | Comment
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US regulators have approved the first therapy based on RNA interference (RNAi), a technique that can be used to silence specific genes linked to disease. The drug, “patisiran“, targets a rare condition that can impair heart and nerve function. The approval is a landmark for a field that has struggled for nearly two decades to prove its worth in the clinic. Researchers first discovered RNAi... Read More | Comment
Upvote Story 12
Intravenous Fish Oil (Omegaven) approved by FDA for use in total parenteral nutrition (TPN) in pediatric patients in the United States. Omegaven 10% Emulsion is a fish oil emulsion administered intravenously in patients who require parenteral nutrition lipid supplementation and cannot tolerate available lipid emulsions. In 2001, Children’s Hospital Boston started doing research on TPN to find out what part of TPN was causing liver... Read More | Comment
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FDA has approved Allergan’s supplemental New Drug Application (sNDA) to expand the approved use of AVYCAZ® (ceftazidime and avibactam) to include the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by the following susceptible Gram-negative microorganisms: Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Serratia marcescens, Proteus mirabilis, Pseudomonas aeruginosa, and Haemophilus influenzae in patients 18 years of age or older. This expanded use... Read More | Comment
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The FDA approved angiotensin-II (Giapreza) as a new intravenous vasopressor for septic shock and other forms of distributive shock. The first new FDA-approved vasopressor in decades, angiotensin-II could significantly change the management of severe septic shock. FDA based its expedited approval (under priority review) on the ATHOS-3 trial enrolling 321 patients with shock refractory to catecholamines like norepinephrine or epinephrine. Read More | Comment
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Intensivists have another antibiotic combination to treat severe infections caused by gram-negative bacteria with the FDA’s approval of Vabomere (meropenem, combined with the beta-lactamase inhibitor called vaborbactam). FDA approved Vabomere only for the treatment of complicated urinary tract infections (such as pyelonephritis). However, licensed U.S. physicians routinely prescribe FDA-approved drugs “off-label” for other indications, especially antibiotics. Read More | Comment
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FDA just cleared Butterfly Network’s iQ an iPhone-connected Ultrasound system, which claims it is the world’s first “ultrasound-on-a-chip” system. Butterfly iQ is FDA 510(k) cleared for diagnostic imaging across 13 clinical applications which span the whole body: Abdominal, Cardiac Adult, Cardiac Pediatric, Fetal/Obstetric, Gynecological, Musculo-Skeletal (Conventional), Musculo-Skeletal (Superficial), Pediatric, Peripheral Vessel, Procedural Guidance, Small Organ and Urology. Butterfly iQ will begin shipping to customers in... Read More | Comment
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Betrixaban, a factor Xa inhibitor, has been approved for the prophylaxis of venous thromboembolism (VTE) in at-risk adult patients hospitalized with an acute illness, according to an announcement from the Food and Drug Administration. Approval was based on results from a randomized, double-blind clinical trial in which over 7,000 hospitalized patients at risk for VTE received either extended-duration betrixaban (35-42 days) or short duration enoxaparin... Read More | Comment
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The FDA has approved labeling changes regarding the use of general anesthetic and sedation medicines in children younger than 3 years. General anesthetic and sedation drugs are necessary for patients, including young children and pregnant women, who require surgery or other painful and stressful procedures, the agency said. In the United States, surgeries in the third trimester of pregnancy requiring general anesthesia are performed only... Read More | Comment
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BioElectronics Corp. has received over-the-counter use market clearance from the FDA for ActiPatch for the adjunctive treatment of musculoskeletal pain related to plantar fasciitis of the heel and osteoarthritis of the knee. BioElectronics is an electroceutical company that develops wearable neuromodulation devices to safely mitigate neurologic diseases and improve quality of life. Its shortwave therapy technology uses low-power, pulsed electromagnetic fields to regulate electrical activity... Read More | Comment
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Since November 2015, approximately 25% of adults who receive annual seasonal influenza vaccination are immunized in pharmacies or retail health care settings. The growth in vaccine uptake at pharmacies has public health policy makers thinking about the next pandemic. Novel and unanticipated influenza viruses create pandemic potential, and manufacturers hurry to create new vaccines. This creates pressure to provide timely vaccine delivery as efficiently as... Read More | Comment
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With streams of data coming from equipment that monitors patients’ vital signs, the ICU seems the perfect setting to deploy artificially intelligent tools that could judge when a patient is likely to take a turn for the worse. "A lot of hospitals are interested in developing early warning systems that can predict life-threatening events like sepsis, cardiac arrest, and respiratory arrest," says Priyanka Shah of... Read More | Comment
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Clarius co-founder and CEO Laurent Pelissier believes the affordable, wireless device could revolutionize health care. The U.S. Food and Drug Administration approved the Clarius ultrasound scanner for use in December 2016, and Health Canada followed suit in January 2017. The company has applied for 14 patents to date relating to several aspects of the scanner, including its ability to generate high quality images and its... Read More | Comment
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When a patient has an aortic valve that requires replacement because the native valve is diseased, 2 types of valves can be used – mechanical valves or bioprosthetic valves, also known as tissue valves. Bioprosthetic valves are less durable than mechanical values but generally do not require the long-term use of anticoagulation; they are often recommended in older patients. Mechanical valves require therapeutic anticoagulation because... Read More | Comment
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A group of researchers are asking the Food and Drug Administration (FDA) to reduce maximum storage limit for red blood cells from 6 weeks to 5 weeks, as long as there are sufficient blood supplies available. The researchers at New York Presbyterian enrolled 60 healthy adult volunteers, who had a single standard, autologous, leukoreduced, packed red cell transfusion after 1, 2, 3, 4, 5, or... Read More | Comment