This episode examines three FDA five ten kay clearances demonstrating distinct device integration strategies. HeartLung’s AI-CVD platform extracts ten measurement domains from forty million routine CT scans annually without workflow modification. Leadoptik’s Last Inch Assessment system embeds silicon metamaterial depth imaging directly into biopsy tools with fifty times greater resolution than current modalities. BD’s EnCor EnCompass system provides cross-modality compatibility across stereotactic, ultrasound, and MRI guided breast biopsy procedures through adjustable vacuum strength and three sixty degree sampling capability. Each clearance addresses procedural economics and reimbursement pathways through different technical architectures for clinical AI integration.
