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The Orbis Microbubble Generator received Health Canada approval in early 2024 and has entered clinical use at major Canadian centers. The company’s novel injectable ultrasound contrast agent, ASI‑02, received FDA IND clearance in April 2025 to begin a multi-center Phase 3 trial assessing safety and efficacy versus standard manual bubble studies. Early results highlight improved workflow efficiency, more consistent microbubbles, better image quality, single operator usability, and potential to improve diagnostic accuracy over traditional methods[2][4][6].
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