An advisory committee for the U.S. Centers for Medicare & Medicaid Services endorsed a series of patient- and clinician-reported outcomes that might not be reflected in the evidentiary bases for currently available technologies. This development suggests some manufacturers will have to conduct new studies of their devices in order to sustain Medicare coverage.
The U.S. FDA posted an update on the early alert for the Novum IQ infusion pump by Baxter International Inc., which includes a suggestion that the administration set be moved half an inch farther down the line before doubling the bolus infusion rate.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Angiodynamics, Aptitude Medical, Carenexa, Longhorn, Matrix Medical, Molecular Testing Labs, MTL, Promega, Renovorx.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Stereotaxis.
While U.S. government cost-cutting seems to be the Trump administration’s priority that consumes all others, some Republican senators are pushing back – at least when it comes to the NIH. Fourteen senators wrote to Russell Vought, head of the White House Office of Management and Budget, to voice their concerns about the administration’s slow disbursement rate of the NIH’s fiscal 2025 funds.
Thoracic aortic dissection can progress to a highly lethal cardiac emergency, but it cannot usually be detected in early stages, so suitable biomarkers of progression are needed. Levels of C-reactive protein in serum rise during progression, but they also rise in infectious or autoimmune conditions, making the biomarker nonspecific.
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