Eleven pages is relatively short for a modern U.S. FDA draft guidance, but two trade associations nonetheless had questions about the FDA draft for transfers of 510(k) devices, such as how the agency defines the holder of the 510(k).
A research team from Pusan National University has developed a novel deep learning model coined Moglo-Net, designed to enable three-dimensional reconstruction of images from hand-held ultrasound procedures.
Kingsley Chin, the CEO of Spinefrontier Inc., has been sentenced to a year of supervised release for his role in the payment of less than $5,000 in consulting fees to a surgeon who provided no consulting services.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 10x Genomics, Cardio Partners, Codex Genetics, Hashkey, IVD Medical, Pacific Edge, Real Heart, Rescuestat, Scale Biosciences.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Nyoxah, Thermo Fisher Scientific.
Billing it as a necessary reform to protect tax dollars from frivolous government spending, redundancy and waste, U.S. President Donald Trump issued a new executive order (EO) requiring his political appointees to sign off on grants and awards from agencies such as the NIH and to monitor those awards over time to ensure they’re being used properly.
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