FDAnews Device Daily Bulletin
Feb. 27, 2012 | Vol. 9 No. 40
Clinical trial sponsors and sites have less than a month before the FDA begins enforcing a new rule that requires informed consent documents to include a specific statement that trial information will be made public on ClinicalTrials.gov, a new guidance states.
Integra subsidiary Theken Spine was handed a Form 483 for failure to submit 11 of 35 complaints involving products made at its Akron, Ohio, facility.
Smiths Medical is issuing a recall for several lots of its Bivona Neonatal, Pediatric and Flextend tracheostomy tubes on reports that if excessive force is used to detach the accessory, the tracheostomy tube may dislodge from the patient.
Mindchild Medical announced the formation of a clinical advisory board (CAB) for its MERIDIAN non-invasive fetal heart monitor.
Osseon Therapeutics announced that its newest product for vertebral augmentation treatment, the Osseoflex SB (steerable balloon), received CE Mark approval for commercial release in the European Union.
GE and AirStrip Technologies have announced that AirStrip patient monitoring, a tool that streams live patient data to iPads and iPhones of critical care physicians, is now available in the U.S.
A Pennsylvania federal jury awarded nearly $37 million to the University of Pittsburgh after finding that Varian Medical Systems willfully infringed a patent for a device used in radiation cancer treatments.
GE, InDevR Scientists Developing Breakthrough Device to Improve Diagnosis of Flu at the Point-of-Care
With the peak of flu season upon us, scientists at GE Global Research, the General Electric Company’s central technology development arm, have been awarded a program through the Defense Advanced Research Projects Agency to develop a breakthrough medical device that can diagnose the flu and other infectious diseases such as malaria, E. coli and salmonella at the point-of-care.
Although vital information for diagnosing and treating disease can be obtained by separating complex mixtures of cells, such as those found in a blood sample, researchers may need to search through billions of other cells in order to collect rare cells, such as fetal cells, tumor cells or stem cells.
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