www.fdanews.com/articles/184188-butterfly-network-receives-510k-clearance-for-chip-based-imaging-system
Butterfly Network Receives 510(K) Clearance for Chip-Based Imaging System
October 31, 2017
Butterfly Network received FDA 510(k) clearance for its ultrasound-on-a-chip based imaging system, the Butterfly iQ for iPhone.
The clearance covers 13 clinical applications for a single ultrasound transducer. The technology combines the capabilities of the typical three probes into a single ultra wide-band, 2D matrix array comprised of thousands of microelectromechanical systems.
The artificial intelligence applications are tightly coupled to the hardware to assist clinicians with image acquisition and interpretation.