Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Lifesignals, Medtronic, Stereotaxis, Microport.
Former U.S. FDA Commissioner Margaret Hamburg has added her voice to concerns that the incoming Trump administration’s pledge to slim down federal agencies will damage public health. “These are certainly challenging times,” Hamburg told delegates at the World Science Forum, Budapest, Hungary, meeting to discuss issues dominating the interface between science and policy.
President-elect Donald Trump’s nomination of Robert F. Kennedy Jr. as U.S. Secretary of Health and Human Services (HHS) grabbed headlines globally, but the political jostling to come will determine whether Kennedy can secure the seat.
Ultromics Ltd. received clearance from the U.S. FDA for Echogo Amyloidosis, its artificial intelligence-enhanced software that helps with the early diagnosis of cardiac amyloidosis, enabling timely intervention that can significantly improve patients' quality of life and extend survival.
Nine out of 10 people with chronic kidney disease have no idea their kidneys are impaired, largely because of a lack of routine testing for albuminuria, one of the earliest biomarker for the disease.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amprion, Delve Bio, Fellow Health, Humancyte, Cnside Diagnostics, Veravas.
Researchers developed a novel electrochemical biosensor technology capable of assessing symmetric dimethylarginine to detect early kidney disease, which could be adapted to detect other biomarkers for conditions like cancer.
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