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FDA approves Butterfly Network’s ultrasound-on-a-chip based imaging system

Butterfly Network has secured approval from the US Food and Drug Administration (FDA) for its ultrasound-on-a-chip based imaging system.

Butterfly iQ for iPhone is claimed to be the world’s first ultrasound-on-a-chip based imaging system, which has been approved to cover 13 clinical applications.

Featuring around ten thousand sensors, the system can be paired with a HIPAA-compliant cloud that enables image storage and collaboration among clinicians, as well as connectivity with traditional hospital medical record systems.

The firm’s ultrasound-on-a-chip technology is said to aggregate the capabilities of three typical probes into a single ultra wide-band and 2D matrix array comprised of thousands of microelectromechanical systems (MEMS).

The sensors are directly covered on an integrated circuit encompassing the electronics of a high performance ultrasound system.

According to the company, the Butterfly iQ is covered by 33 issued patent uniquely melding micromachines and integrated circuits.

The company has developed deep learning-based artificial intelligence applications, which provides clinicians with both image acquisition and interpretation.

Butterfly Network's chief medical officer Dr John Martin said: "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.”

Butterfly Network founder and chairman Dr Jonathan Rothberg said: "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.”


Image: The FDA campus in New Hampshire Ave, Silver Spring, Maryland. Photo: courtesy of The U.S. Food and Drug Administration.