Powerful Medical has received FDA Breakthrough Device designation for its PMcardio STEMI AI ECG model, designed to rapidly detect signs of ST-elevation myocardial infarction (STEMI)
Alnylam Pharmaceuticals has secured U.S. Food and Drug Administration (FDA) approval for vutrisiran, a subcutaneous injection marketed as Amvuttra, to treat adult patients with transthyretin
MedCAD, based in Dallas, has received 510(k) clearance for its AccuStride Foot and Ankle System, a patient-specific precision device designed to assist surgeons in treating
MiRus has launched a U.S. multi-center early feasibility study for its Siegel transcatheter heart valve (THV), following first-in-human data from Chile last year. The first
JenaValve has announced promising results from an expanded cohort of 500 patients in the ALIGN-AR pivotal trial, evaluating its Trilogy transcatheter heart valve (THV) system
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