SOURCE: Butterfly Network, Inc.

October 27, 2017 01:10 ET

First Ultrasound-on-a-Chip receives broadest FDA 510(k) clearance

A window into the human body for less than $2,000 enabled by breakthrough Ultrasound-on-a-Chip technology

GUILFORD, CT--(Marketwired - October 27, 2017) - Butterfly Network Inc. announced today 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. By combining almost 10 thousand sensors, 40 times more than systems costing 100 times as much, Butterfly ushers in a new era of accessible, high-performance medical imaging.

"Offering a unique blend of affordability, diagnostic versatility, and assistive intelligence, Butterfly has the potential to impact human health more profoundly than any diagnostic device since the stethoscope, invented over 200 years ago. At less than $2,000, healthcare providers can purchase an easy-to-use, powerful, whole-body medical imaging system that fits in their pocket," said Dr. John Martin, Butterfly Network's Chief Medical Officer. "By removing the barrier of price, I expect Butterfly to ultimately replace the stethoscope in the daily practice of medicine. We can now provide a diagnostic system to address the millions of children that die of pneumonia each year and the hundreds of thousands of women that die in childbirth, and these are just two examples of the impact this technology will have."

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. Moving the ultrasound machine to a chip allows it to be produced at unprecedented scales, at prices and rates of improvements that obey Moore's law and will enable a series of future form factors.

Semiconductor fabrication reduces hardware costs 10 to 100 fold.
The Butterfly iQ's disruptively low price is enabled by breakthrough engineering and is covered by 33 issued patents uniquely melding micromachines and integrated circuits. Butterfly directly leverages the $3 trillion dollars that went into developing the global semiconductor supply chain, currently at the heart of the revolution in consumer electronics, telecommunications, computers, and smartphones.

"Just as putting a camera on a semiconductor chip made photography accessible to anyone with a smart phone and putting a computer on a chip enabled the revolution in personal computing before that, Butterfly's Ultrasound-on-a-Chip technology enables a low-cost window into the human body, making high-quality diagnostic imaging accessible to anyone," said Dr. Jonathan Rothberg, founder and chairman of Butterfly Network. "Two thirds of the world's population has no access to medical imaging, that's not ok, and today our team is doing something about it. And they are just getting started."

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. "Deep learning and ultrasound imaging are a perfect combination," said President Gioel Molinari. "As physicians use our devices in the field, they help improve the neural network models. 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 ultrasound." Butterfly plans to release assistance and interpretation functionality in 2018 as a software add-on to the Butterfly iQ system.

Cloud and Storage Solutions
The Butterfly iQ is paired with a HIPAA-compliant cloud which enables image storage and collaboration among clinicians as well as connectivity with traditional hospital medical record systems. Butterfly Cloud's fleet management capabilities offer healthcare administrators a top-down window into the utilization and return-on-investment of ultrasound in their facilities.

Learn more at www.butterflynetwork.com

ACEP
Butterfly Network will be demonstrating the iQ at the American College of Emergency Physicians (ACEP) conference in Washington DC. Attendees can visit at booth 1549 for a demonstration from Oct. 29 to Oct. 31. The Butterfly iQ will also be on display at the InnovatED section of the ACEP exhibition.

About
Butterfly Network has created and brought to market the first FDA-cleared device based on putting an ultrasound machine on a semiconductor chip. Pairing ultrasound-on-a-chip with the cloud and AI, they are on a mission to democratize medical imaging. Butterfly Network is a member of the 4Catalyzer life sciences incubator, founded by Dr. Jonathan Rothberg, best known for inventing next-generation DNA sequencing technology underlying the personal and precision medical revolution.

FDA Clearance Link

LINK TO DROPBOX MEDIA

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