Butterfly iQ/iQ+ Ultrasound System
Butterfly Network, Inc.The Butterfly iQ/iQ+ Ultrasound System is a portable, handheld ultrasound device that helps healthcare professionals visualize and measure anatomical structures and fluids in both adult and pediatric patients. It supports multiple clinical applications including lung, cardiac, abdominal, and musculoskeletal imaging. The system integrates AI-powered software called Auto B-line Counter that automatically detects and counts B-lines in lung ultrasound images, aiding clinicians in diagnosing and monitoring lung conditions.
Intended Use
The Butterfly iQ/Butterfly iQ+ Ultrasound System is indicated for use by trained healthcare professionals to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients for multiple clinical applications, including lung imaging.
Technology
The system is a handheld ultrasound device with a single probe and broad imaging capabilities compatible with commercial mobile devices. It includes an AI-enabled software algorithm, Auto B-line Counter, that automatically detects and counts lung B-lines from ultrasound images integrated into the Butterfly iQ/iQ+ mobile application.
Performance
Performance testing demonstrated that the AI Auto B-line Counter algorithm performs as well as expert human annotators in detecting and counting B-lines, based on a validation dataset of 6000 de-identified ultrasounds from diverse clinical sites and a clinical evaluation on 99 subjects showing consistent accuracy across demographic and clinical subgroups. The algorithm passed analytical and non-clinical testing supporting safety and effectiveness without added risk.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/10/2022
1 year, 2 months - 2
FDA Approval
3/31/2023
Other devices from Butterfly Network, Inc.
- Butterfly iQ3 Ultrasound System2024 • 510K
- Auto 3D Bladder Volume Tool2020 • 510K
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