Ultrasound Transducer from Butterfly Network Receives FDA Approval for 13 Applications

The pocket-sized transducer based on ultrasound-on-a-chip technology plugs into iPhones.

Ultrasound imaging allows for noninvasive imaging of soft tissues such as muscles and tendons, glands, neonatal brains and many different organs. It used in both the diagnosis and treatment of many conditions and diseases. Current ultrasound instruments are unwieldy, however. They consist of at least three transducers and thus are large and typically wheeled around on a cart, which can be challenging in emergency rooms. In addition, according to the National Institute of Biomedical Imaging and Bioengineering, they use piezoelectric materials – generally crystalline ceramics – to generate and receive the ultrasound waves.

The US Food and Drug Administration has approved a new device from Butterfly Network that could change the way ultrasound is performed. The Company’s portable iQ ultrasound-on-a-chip technology integrates the capabilities of the three typical ultrasound probes into a single 2D matrix array comprising thousands of microelectromechanical systems. Overlaying this array is an integrated circuit with electronics like those found in high-performance ultrasound systems.

With the hand-held device, the result of a body scan can be seen on an iPhone. In addition, because the three transducers needed in a traditional machine are combined into one in the iQ system, there is no need to switch out transducers in order to image different parts of the body, which reduces the time required. As an added benefit, the images are stored in the cloud for access from multiple locations.

FDA approved the device for a total of 13 clinical applications (musculoskeletal, cardiac and peripheral vessel), the most ever for any one ultrasound transducer. Butterfly Network is pricing the device under $2000 and will begin shipping the product in 2018.

"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 Butterfly CEO and founder Jonathan Rothberg. "Two-thirds of the world's population has no access to medical imaging, … and today our team is doing something about it. And they are just getting started."

Added John Martin, M.D., Butterfly’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.”

Nigel Walker

Mr. Walker is the founder and managing director of That’s Nice LLC, a research-driven marketing agency with 20 years dedicated to life sciences. Nigel harnesses the strategic capabilities of Nice Insight, the research arm of That’s Nice, to help companies communicate science-based visions to grow their businesses. Mr. Walker earned a bachelor’s degree in graphic design with honors from London College of Communication, University of the Arts London, England.