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Abbott’s MitraClip cut the rate of hospitalizations while improving survival for heart failure patients with severe secondary mitral valve regurgitation (MR) in a five-year study at multiple U.S. medical centers.
To help prevent the approval of AI medical devices that “mirror or exacerbate” existing health disparities, the FDA should develop a “distinct regulatory process” for artificial intelligence (AI)-driven software as a medical device (SaMD), say several academic researchers.
BlueStar Telehealth reported that its in-home remote patient monitoring program (RPM) using SmartMeter’s iBloodPressure cellular-connected blood pressure devices saw improvements in all patients with uncontrolled hypertension.
In a postmarket study, IRRAS’s IRRAflow fluid exchange system more effectively removed blood from chronic subdural hematomas (cSDH) and reduced catheter-related infections when compared to passive drainage alone, researchers reported in the journal Operative Neurosurgery.
aragonix Technologies’ LUNGguard donor lung preservation system recently saw its first use for a pediatric case in which donor lungs procured overnight were preserved with the system, allowing for next day transplant surgery.