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In this week’s Pathways Picks: EU lawmakers seek to clarify MDR/IVDR, not AI Act, as controlling authority over AI-enabled devices; MDR certifications grow; FDA issues guide on patient preference information; active South Korea agency approves first generative AI device and expands real-world evidence use; and more updates from Europe, the US, and South Africa.
Addressing heart failure, Levron Cardiovascular synchronizes the body's "respiratory" pump with the heart beat, to shift fluid out of the lungs and boost outflow from the left ventricle. In essence, the concept turns a physiological interaction that normally exists in the body into a therapeutic advantage. A companion article to "Innovating Heart Failure: Start-Ups Harness Natural Pathways."
The treatment of low back pain is beginning to move toward a more stratified, personalized model of care. Scientific and technological advances are creating opportunities for new entrants in the market. Excerpted from our recent feature article.