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FDA Clearance for Butterfly iQ, Handheld Ultrasound Probe

FDA Clearance for Butterfly iQ, Handheld Ultrasound Probe

Dedicated to democratizing ultrasound, Butterfly Network’s dream becomes reality at the intersection of semiconductor engineering, artificial intelligence, and the cloud. Butterfly Network Inc. announced that it has received FDA 510(k) clearance for the world’s first Ultrasound-on-a-Chip based imaging system, the Butterfly iQ for iPhone. The clearance covers 13 clinical applications, the broadest ever for a single ultrasound transducer.
Dr. Jonathan Rothberg, founder, and chairman of Butterfly Network predicted the device’s impact would be not unlike the milestone development of camera phones. Jonathan Rothberg founded the company in 2011. He previously started and sold DNA sequencing companies 454 to Roche Diagnostics and Ion Torrent Systems to Life Technologies.
Butterfly Network develops handheld semiconductor-based ultrasound systems. Butterfly Network’s first product, the Butterfly iQ is the world’s first personal ultrasound system. It supports cardiac, abdominal and superficial imaging with a single wideband transducer connected to your iPhone. Butterfly Network’s Ultrasound-on-a-Chip technology modernizes ultrasound by delivering unparalleled diagnostic versatility at a price of under $2000 that any clinician can afford.
The device is designed for three different settings: the emergency room, the intensive care unit, and medical education. It’s not intended to replicate the quality of a larger imaging device but it’s designed with portability as a priority. Butterfly ushers in a new era of accessible, high-performance medical imaging. First of its kind 3-in-1 transducer provides maximum versatility and convenience. To image the entire body, a traditional ultrasound system requires a large, expensive cart or box which connects to three or more piezoelectric-based transducers, each costing thousands to tens of thousands of dollars. Butterfly’s Ultrasound-on-a-Chip technology combines the capabilities of the typical three probes into a single ultra wide-band, 2D matrix array comprised of thousands of microelectromechanical systems (MEMS). These sensors are directly overlaid on an integrated circuit encompassing the electronics of a high-performance ultrasound system. The acoustic bandwidth and processing power available from the MEMS and electronics fusion creates unprecedented diagnostic versatility, speeds, modes, and resolutions.

Ultrasound that learns

Butterfly Network has developed deep learning-based artificial intelligence applications that are tightly coupled to the hardware and assist clinicians with both image acquisition and interpretation. The more physicians use Butterfly devices, the better they will get. Improvements to acquiring and interpreting images will ultimately enable less skilled users to reliably extract life-saving insight from an ultrasound. Butterfly plans to release assistance and interpretation functionality in 2018 as a software add-on to the Butterfly iQ system.
I think the Butterfly iQ will revolutionize the medical field in many ways. Having access to the probe can save crucial time in diagnosing various diseases and start treatment as soon as possible. The traditional ultrasound machine can seem intimidating to patients but the probe is a small, portable device that can accompany a medical personnel anywhere including remote locations, with access to limited resources, that may require emergency medical assistance.

News & Image Source: Meet Butterfly iQ – Whole body imaging, under $2k, MedCity News


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