A new review program will be launched jointly by the FDA and the Department of Defense to expedite safety and efficacy review of medical products and devices judged to be essential for lifesaving treatments of US military personnel, with high-priority products for review to include cold-stored platelets, cryopreserved platelets and freeze-dried plasma. At least one workshop will be held by the agency and the department this year to inform FDA guidance on determining "unmet medical needs for battlefield settings," according to an initial blueprint for the initiative.
Jennifer Opprecht had spinal surgery that used donated bone to create a spacer in place of her C-6 vertebra. "Instant relief," Opprecht said of the surgery. "My neurosurgeon told me that if I didn't have the surgery, I was on my way to paralysis. It really saved my life."
A retrospective study in the journal The Oncologist found that many lymphoma patients age 70 and older who received stem cell transplants had positive outcomes. Out of 107 patients, 65% survived at least two years after their transplants, while no disease progression was experienced by 58% of the patients.
A campaign to vaccinate almost 20 million Brazilians against yellow fever will be conducted in February and March, and the World Health Organization has recommended that all travelers to Sao Paulo state be vaccinated for the disease.
Researchers have discovered how the dengue virus replicates itself in an infected person while not setting off the body's defense mechanisms, according to findings published in the Journal of Virology. The investigators found that "the virus takes over the machinery and makes a ton of itself, but so slowly and inefficiently that it doesn't set off any of the sensors the host cell uses to detect when something is awry," said senior study investigator Christopher Nicchitta of Duke University School of Medicine.
The Ugandan government said tests have confirmed a case of Crimean-Congo hemorrhagic fever in a 9-year-old boy. The child is hospitalized and the virus has cleared, according to health officials.
Robust quality controls are essential when using matrix-assisted laser desorption/ionization time-of-flight mass spectrometry in clinical microbiology labs, a recent document from the Clinical and Laboratory Standards Institute says. "As more laboratories abandon traditional methods in favor of MALDI-TOF MS, those that make the switch absolutely need to follow best practices for quality control by adhering to recommendations given by instrument manufacturers, regulatory agencies, and other guidelines," notes Lori Bourassa, assistant director of the clinical microbiology division at the University of Washington Medical Center.
A bill that would eliminate the medical device tax was unveiled by Sens. Ed Markey and Elizabeth Warren, both D-Mass. The No Taxation on Device Innovation Act would end oil company tax breaks projected to be worth $29 billion over the next 10 years to offset the cost of the device tax repeal.
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