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- FDA Announces First Participant Selected for TEMPO for Digital Health Devices PilotThe U.S. Food and Drug Administration today announced the first manufacturer selected for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot.fda press · 8d ago↗ source
- FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol in Adults with High CholesterolThe U.S. Food and Drug Administration approved Lipfendra (enlicitide), the first oral inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9), as an adjunct to diet and exercise to reduc…fda press · 13d ago↗ source
- Heart Pump Recall: Abiomed Removes Impella CP Sets with SmartAssistSpecific Impella CP Sets are out of specification; use may result in low purge pressure events from the onset of the case