Butterfly Network Inc. (“Butterfly,” “the Company”) (NYSE: BFLY), a digital health company transforming care with portable semiconductor-based ultrasound technology and intuitive software, announced the commercial launch of its third-generation handheld point-of-care ultrasound (POCUS) system, Butterfly iQ3 in Europe. Butterfly iQ3 is powered by the Company’s most advanced semiconductor chip, enabling unparalleled image quality and new advanced 3D capabilities: iQ Slice and iQ Fan.
Butterfly iQ3 is CE marked, certified under European Union Medical Device Regulation (EU MDR), and it is fully compliant with the Restriction of Hazardous Substances (RoHS) Directive without relying on the lead exemption that traditional piezoelectric crystal-based ultrasound devices require due to hazardous levels of lead in their transducers.
Joseph DeVivo, Butterfly Network’s President, Chief Executive Officer, and Board Chairman, commented, “After witnessing the enthusiastic uptake of Butterfly iQ3 in the United States and Canada over the past few months, we’ve been eager to receive the regulatory approval to introduce this high-performance device in Europe. We’re confident that the enhanced image quality and advanced features of Butterfly iQ3 will bring significant value to healthcare providers across Europe, supporting them in delivering quality patient care. Our mission to democratize ultrasound continues, and we are excited to continue seeing the promise of Butterfly iQ3 benefit new regions.”
Butterfly iQ3 brings best-in-class high-resolution image quality with twice the processing power compared to Butterfly iQ+ and a novel “no focus” rubber lens, enabling providers to intuitively identify anatomy, observe small structures, and ultimately make more confident diagnostic decisions. In a blind survey distributed by third-party vendor Intellisurvey, 475 clinicians across more than eight specialties compared Butterfly iQ3 images to GE Vscan Air™ CL, with the majority across all categories ranking iQ3’s overall image quality better than that of GE Vscan Air™ CL.*
“I was privileged to have a preview of the Butterfly iQ3 and am thoroughly impressed with the improvements so far and the positive impact they will have on patient care in my practice,” said Dr. Zack Ferguson, Specialty Registrar in Acute Internal Medicine at West Middlesex Hospital. “Notably, the enhancement in echo image quality on the new Butterfly iQ3 represents a significant advancement from the prior iQ models, and the biplane mode for cannulation has already proven beneficial in managing patients with challenging IV access.”
