Findings from two international, randomized, double-blind, phase III, placebo-controlled trials published in the September issue of Gastroenterology revealed that the oral second-generation thrombopoietin agonist avatrombopag (Doptelet) when given once a day, notably decreased the requirement for platelet transfusion...
Adherium, the makers of inhaler sensors, has received 510(k) US-FDA clearance for the sales of its Hailie sensor, previously known as Smartinhaler. The individual versions of this device were previously cleared for use with the asthma inhalers like Ventolin HFA, ProAir HFA, and Flovent HFA.
The US-FDA has warned against medical device manufacturers for developing cosmetic vaginal rejuvenation procedures to treat vaginal atrophy, laxity, itching/dryness, pain during sex or urination and reduced sexual sensation.
Endomag received premarket approval from the FDA for Magtrace, the novel non-radioactive dual-tracer for lymphatic plotting in breast cancer patients which facilitates the implementation of magnetic detection during sentinel lymph node biopsy procedures to spot sentinel lymph nodes for surgical excision.
Various synthetic cannabis products such as “spice” and K2 have been contaminated with a rat poison ingredient that affects the blood supply. Hundreds of people in 10 states in the USA have been diagnosed with symptoms like seizures and severe bleeding after using these products, as declared by US-FDA.
A phase 2 study on BAN2401, a monoclonal antibody that hits soluble amyloid beta oligomers, showed that it limits cognitive decline in patients with slight cognitive injury or premature Alzheimer’s dementia on two scales and removed brain amyloid in 81% of patients in the trial.
Healthy.io, of Israel, gains FDA 510(k) approval for Dip.io, it's domestic urinalysis kit that transforms a smartphone into a clinical-standard diagnostic machine. It is the first and only smartphone-based urine analysis to be cleared as a Class 2 device.
At the beginning of this month, the U.S. Food and Drug Administration (FDA) announced to withdraw drugs containing valsartan, which treat high blood pressure and heart failure. The drugs were withdrawn due to the presence of N-nitrosodimethylamine (NDMA), which might lead to cancer.
Bayer announced on last Friday that it would stop the sales of its Essure birth control system in the United States by the end of this year due to a steady decline in its sales making the product no longer justifiable. Bayer insisted that its decision to discontinue Essure sales is only for business reasons and not for any safety or efficacy concerns.
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