iPhone-based “ultrasound on a chip” wins FDA clearance
According to the company, its Butterfly iQ product received FDA 510(k) clearance covering 13 clinical applications – the broadest ever for a single ultrasound transducer. Butterfly iQ combines almost 10,000 sensors – 40 times more than systems costing 100 times as much – and, says the company, promises “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,” says Dr. John Martin, Butterfly Network’s Chief Medical Officer. “At less than $2,000, healthcare providers can purchase an easy-to-use, powerful, whole-body medical imaging system that fits in their pocket.
“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.”
Compared to a traditional, large ultrasound system that connects to three or more expensive piezoelectric-based transducers, Butterfly’s ultrasound-on-a-chip technology offers similar capabilities in a single ultra-wide-band, 2D matrix array of thousands of microelectromechanical systems (MEMS) overlaid on an IC containing the electronics of a high-performance ultrasound system. According to the company, its technology offers “unprecedented diagnostic versatility, speeds, modes, and resolutions,” while at the same time reducing hardware costs 10 to 100 fold.
“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,” says 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.”
Butterfly IQ is FDA 510(k) cleared for diagnostic imaging across clinical applications spanning the whole body. These include abdominal, cardiac adult, cardiac pediatric, fetal/obstetric, gynecological, musculo-skeletal (conventional), musculo-skeletal (superficial), pediatric, peripheral vessel, procedural guidance, small organ, and urology.
The company has developed deep learning-based artificial intelligence applications that are tightly coupled to the hardware and designed to assist clinicians with image acquisition and interpretation. A software add-on to the Butterfly iQ system is planned for release in 2018 that will offer assistance and interpretation functionality.
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