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Devicemaker YFS Pharma did not investigate or keep detailed records of complaints it received about its Lubricity dry mouth sprayer, FDA investigators observed during an inspection of the company’s Buffalo, N.Y., facility. Read More
The Hemolung procedure takes up to five days in adults with acute, reversible respiratory failure for whom ventilation of carbon dioxide cannot be adequately or safely achieved using other available treatment options, the company said. Read More
GE has been offering the algorithm since November 2020 based on the FDA’s COVID-19 emergency guidance for imaging, citing its potential to help clinicians treating critically ill COVID-19 patients who require ventilation. Read More
An FDA inspection of a Philips Respironics facility in Pennsylvania has turned up problems that will delay the company’s replacement of millions of its ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines. Read More
HHS withdrew a temporary policy yesterday that directed the FDA not to enforce its premarket review requirements for laboratory developed COVID-19 tests — an emergency policy that was put in place to get tests quickly into use during the pandemic. Read More
It is important that viral transport media “are appropriately designed and validated prior to distribution to ensure that the transport medium will preserve the viral particles without meaningful degradation that could lead to inaccurate test results,” the agency said. Read More
EndoScreener demonstrated its efficacy in improving adenoma detection in more than 5,000 patients in six randomized controlled trials, the company said. Read More
Equipment operators and items brought into a plant are the two chief reasons for contamination in manufacturing clean rooms, said disinfecting expert Jim Polarine during an FDAnews webinar hosted last week. Read More