ResMed Respiratory Masks With Magnets Stay On Sale Despite Recall
The mask recall had been classified as "most serious" by the FDA because of the risk of injury or death. But ResMed argued the issue centers on a labeling matter and is not a product removal. Separately, a CRISPR gene therapy for sickle cell can be used on a different disorder, the FDA said.
ResMed said its respiratory masks containing magnets will remain on the market even though the U.S. Food and Drug Administration classified a recall of the product as most serious as their use could cause major injuries or death. The California-based medical device maker, which started the recall process on Nov. 20, said the classification was due to a correction in the labeling and is not a product removal. (1/16)
In other pharmaceutical news 鈥
A therapy based on CRISPR gene-editing technology that the Food and Drug Administration approved in December for sickle cell disease can be used for a second inherited blood disorder, the agency said on Tuesday. (Bettelheim, 1/17)
When Kelsey Brown met Mohammed, the 15-year-old Ugandan boy looked terribly worried. He was in the late stages of rheumatic heart disease, which kills about 400,000 people a year worldwide. His scheduled heart surgery to address the illness had been postponed a day. By this point, fluid that backed up from Mohammed鈥檚 heart into his lungs made it so hard to breathe that he had to sleep sitting upright. Brown, a cardiology fellow at Children鈥檚 National Hospital in Washington, assumed that he was anxious about undergoing the surgery. But Mohammed told her that he was not scared to face the procedure. (Johnson, 1/16)
The chemotherapy Christine Ko was prescribed for her breast cancer is pretty much a guarantee for losing your hair. The intervention her doctors offered to prevent the hair loss was a cold cap that, cooled to 32 degrees Fahrenheit, would turn her scalp into an icy crown. But, to her, it wasn鈥檛 much of an option. (Chen, 1/17)
Washington University has joined up with a New York investment firm to launch a new drug research and development business, the school announced Tuesday. Deerfield Management Co. has committed up to $130 million over the next decade. The new company will be called VeritaScience, a nod to the university鈥檚 motto, 鈥淧er Veritatem Vis,鈥 or 鈥淪trength Through Truth.鈥 (Merrilees, 1/16)
More than half of those responsible for registering clinical trials and reporting results fail to do so over confusion about key requirements, according to a new survey that highlighted ongoing difficulties in achieving transparency surrounding study data. (Silverman, 1/16)
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This week on the 麻豆女优 Health News Minute: A national shortage of Adderall leaves people with narcolepsy struggling to live normal lives. and researchers find little evidence that mental health courts are keeping those who need them most out of lockup. (1/16)
