Tag: FDA
Diagnostic Imaging on iPhone
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... read more
FDA approves betrixaban for VTE prophylaxis
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.... read more
FDA Approves Label Changes for Pediatric General Anesthetic and Sedation Drugs
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... read more
Drug-Free Musculoskeletal Pain Therapy Given Clearance by FDA
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... read more
Pharmacists Can Make a Difference During Influenza Pandemics
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... read more
In Hospital ICUs, AI Could Predict Which Patients Are Likely to Die
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... read more
This Handheld Ultrasound Scanner Could Be the Next Stethoscope
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,... read more
Transcatheter Aortic Valve Replacement in Younger Individuals
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... read more
FDA Recommendation: Reduce Max Storage Limit of RBCs
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... read more
Metformin Associated with Reduced Mortality in CKD, CHF, and CLD
Metformin is currently the suggested initial treatment for type 2 diabetes mellitus in the United States. In the past, the U.S. Food and Drug Administration (FDA) did not recommend metformin for patients with chronic kidney... read more
New Warning for Anesthetic Use in Children and Pregnant Women
The FDA issued a warning that repeated or lengthy use of general anesthetics and sedatives during surgeries or procedures in children aged <3 years or in pregnant women during their 3rd trimester may affect the development... read more
Pulmaquin Looks Promising for Treating Lung Infections in Non-CF Bronchiectasis Patients
Aradigm has announced top-line results from two Phase 3 clinical trials of Pulmaquin (inhaled ciprofloxacin) for the treatment of patients with non-cystic fibrosis bronchiectasis (non-CF BE) who have chronic lung infections... read more
Physicians at RSNA make case for contrast enhanced ultrasound
The procedure, which was OK'd by the FDA this year for liver screening, but is currently not approved in the U.S. for cardiac disease shows particular value in imaging children who may otherwise have to undergo a CT... read more
Value of Expedited Drug Approvals for Cancer Care
This study examines potential benefits of cancer drugs approved by the FDA on the basis of surrogate endpoints.... read more
How to prevent spread of the skin infection impetigo
Impetigo is a contagious skin infection that's preventable and can be treated with antibiotics, the U.S. Food and Drug Administration says. Impetigo can strike anytime but is more common during warm weather months. More... read more
FDA Approves Defibrillator That Automatically Adjusts Pacing
The FDA has cleared the Claria MRI Quad Cardiac Resynchronization Therapy Defibrillator (CRT-D) SureScan device (Medtronic) for patients with heart failure.... read more
Hepatitis B Drug Combination Approved
Tenofovir-alafenamide combination approved by the FDA for chronic hepatitis B infection.... read more
New discovery paves way for pancreatic cancer treatment
Patients suffering from pancreatic cancer may soon face better treatment options due to the latest discovery by Dr. Reginald Hill, who's research focuses on drugs that are already approved by the FDA.... read more
FDA Approves Carnexiv Injection for Seizures
The FDA has approved Carnexiv (carbamazepine) injection as a short-term replacement therapy for oral carbamazepine formulations for adults with certain seizure types.... read more
FDA approves new device for prevention of recurrent strokes in certain patients
FDA approved the Amplatzer PFO Occluder device which reduces the risk of a stroke in patients who previously had a stroke believed to be caused by a blood clot that passed through a small hole in the heart, called a patent... read more
FDA to radiologists: stop using any Multidata Systems devices
At least two devices distributed in U.S. without FDA approval. There have been at least two Multidata medical devices that the company manufactured and distributed in the United States for which FDA never received nor reviewed... read more
FDA Approves Zinplava to Reduce Recurrence of Clostridium difficile Infection in Adult Patients
FDA Approves Merck's ZINPLAVA (bezlotoxumab) to Reduce Recurrence of Clostridium difficile Infection (CDI) in Adult Patients Receiving Antibacterial Drug Treatment for CDI Who Are at High Risk of CDI Recurrence.... read more
