Butterfly iQ+ is a general-purpose second-generation, diagnostic ultrasound imaging system developed by Butterfly Network, a digital health company based in the US.
Classified as a Class IIa portable ultrasound system, Butterfly iQ+ is used for diagnostic ultrasound imaging and assessment of adult and paediatric patients’ anatomical structures and fluid for clinical applications such as procedural guidance, foetal or obstetric treatment, cardiac assessment, peripheral vessels, urology and ophthalmic treatments.
Butterfly launched the first ultrasound system, Butterfly iQ, using semiconductor technology, in 2018. Leveraging the advantages of Moore’s Law, the company introduced its second-generation Butterfly iQ+ in 2020 and the third-generation iQ3™ in 2024, both featuring enhanced processing power and performance.
The Butterfly iQ was launched to the International Space Station aboard the SpaceX Dragon cargo resupply payload in June 2021. The Translational Research Institute for Space Health (TRISH) is facilitating the inaugural user demonstration of the product in space.
The technology has been recognised by awards including TIME’s Best Inventions, Fast Company’s World Changing Ideas, CNBC Disruptor 50 and MedTech Breakthrough Awards.
Regulatory approvals for the Butterfly iQ+ ultrasound system
The Butterfly iQ® for iPhone received the US Food and Drug Administration (FDA) 510(k) clearance for human use in October 2017, becoming the world’s first approved ultrasound-on-a-chip-based imaging device.
Butterfly iQ® obtained CE Mark approval in April 2019, allowing licenced medical professionals in the UK, Europe, Australia and New Zealand to receive the ultrasound system. Health Canada cleared the device in March 2020.
In August 2021, Butterfly Network entered an exclusive strategic collaboration with Caption Health, an artificial intelligence (AI)-based ultrasound software developer, to incorporate a comprehensive AI-guided solution on the Butterfly iQ+ platform for early diagnosis and management of diseases.
The FDA approved Butterfly iQ3, a next-generation handheld point-of-care ultrasound system (POCUS), in January 2024. It is the third version of the world’s first semiconductor-based single-probe, whole-body ultrasound system Butterfly iQ.
Butterfly iQ+ ultrasound system details
Butterfly iQ+ is an easy-to-use, battery-powered ultrasound system integrated with a commercial off-the-shelf mobile platform for a simple user interface. The device is powered by next-generation, patented Ultrasound-on-Chip™ semiconductor technology, which allows high-resolution cardiac myocardial boundaries and flow dynamics to be observed.
Butterfly iQ+ comprises three components, namely compatible Apple® or Android mobile devices, the Butterfly iQ application on the compatible device, and a probe that facilitates connection with the mobile device to generate and receive ultrasound signals.
The device has several modes of operation: B-Mode, B-Mode + M-Mode, B-Mode + Colour Doppler, and B-Mode + Power Doppler.
The device’s state-of-the-art Needle Viz™ technology provides enhanced needle-controlling capabilities for healthcare professionals, improving accuracy in dual-imaging mode and more complex in-plane guided procedures.
Management and storage solutions
The Butterfly iQ utilises a Health Insurance Portability and Accountability Act (HIPAA)-compliant Cloud for unlimited image storage, communication among clinicians and connection with standard hospital medical record systems.
The Butterfly Cloud supports ultrasound fleet management, providing healthcare administrators with a top-down view of ultrasound use and return on investment in their facilities.
Benefits of the Butterfly iQ+ ultrasound system
The Butterfly iQ+ is an innovative low-noise device with reduced power consumption. Its optimised electronics are integrated with a power-efficient field-programmable gate array chip, which offers a 20% longer battery life and improved thermal performance while doubling scanning time.
The system offers sharp images with faster processing ability, while its true-to-form colour flow enhances the clarity of haemodynamic flow.
The Butterfly iQ’s patented on-chip digital micro-beamforming technology enables 15% higher frame rates and 60% faster pulse repetition frequency. The device can optimise 1.75D array beamforming for an 85% reduction in elevation beamwidth.
The system has military-grade durability and can endure drops of up to 4ft and electric shocks of up to 100G. It meets IP67 industry standards and can resist dust and water.
The device improves cardiac assessment by allowing images to be captured and interpreted easily in care settings including hospitals, clinics and homes.
The system’s Needle Viz technology helps clinicians make quick decisions at the bedside by allowing bladder volume to be calculated automatically in four seconds, using the AI-based Auto Bladder Volume tool.
Needle Viz also aims to improve clinicians’ confidence for central line placements, vascular access, blocking regional nerves, musculoskeletal injections and other guided procedures.
Butterfly iQ3 ultrasound system details
The Butterfly iQ3 ultrasonic device features a user-friendly ergonomic design, smaller probe faces, a more powerful battery, lighter and better weight distribution, and doubled data processing speed to improve image resolution, sensitivity and penetration. It also has quicker 3D capabilities to enable two new automatic image capture modes: iQ Slice™ and iQ Fan™.
A 17% smaller probe face offers improved intercostal access for cardiac and lung imaging, as well as enhanced vascular access. The probe, 7% shorter and with an ergonomically distributed weight, reduces strain on scanners, ensuring precise and comfortable scans.
Three configurable control buttons allow for seamless navigation and quick scans. The device offers a charge time 2.5 times faster than that of the Butterfly iQ+, along with up to two hours of continuous scanning thermal run time.
With the fastest digital data transfer in the world, Butterfly iQ3 is based on the next-generation P4.3 Ultrasound-on-Chip™ technology which improves frame rates and frequency, and adds new 3D imaging capabilities. The result is superior image clarity and quicker micro-beamforming for advanced 3D capabilities, such as iQ Slice™ and iQ Fan™. The tools complement Butterfly’s existing features, including more than 20 anatomical presets, six imaging modes and AI-powered imaging tools such as Auto Bladder Volume Capture, Auto B-Line Counter, NeedleViz and a range of calculation tools.
The next-generation P4.3 chip was developed with Taiwan Semiconductor Manufacturing (TSMC) through the integration of innovative complementary metal-oxide-semiconductor-micro-electro-mechanical systems technologies.
Butterfly iQ3 offers an innovative “no focus” rubber lens, allowing medical professionals to easily recognise anatomy, monitor small structures and make more accurate diagnostic decisions.
The Auto B-Line Counter determines the maximum number of B-lines that can appear in a single frame of a movie using the Instant Percent approach. Auto B-line Counter is available on all Butterfly iQ, iQ+ and iQ3, and can be accessed in the Lung Preset while scanning in B-Mode.
Butterfly iQ Slice and iQ Fan details
Butterfly’s patented Ultrasound-on-Chip™ technology enabled the first automated, sequential ultrasound capturing mode on a portable device.
iQ Slice™ effortlessly directs the beam to scan an organ, capturing up to 46 ultrasonic sections simultaneously from a wide angle. The imaging mode is designed to simplify and expedite the process of acquiring high-quality images, eliminating the need for expert handling. The collected data can be promptly assessed and measured at the bedside by skilled scanners or forwarded to a specialist for in-depth analysis, mirroring the functionality of a CT or MRI.
Butterfly iQ Fan™ is a specific lung tool that expands on the basic iQ Slice technology to give physicians real-time, back-and-forth virtual fanning, making it simpler to see A-lines and other lung problems. With iQ Fan™, the user is no longer required to manually fan the probe and can instead focus on analysing the images.
Clinical trials on Butterfly iQ3 ultrasound system
In a blind study conducted by third-party vendor Intellisurvey, 475 physicians from more than eight specialities compared Butterfly iQ3 images to those of GE Vscan Air™ CL. The majority across all categories rated iQ3’s overall image quality higher than that of GE Vscan Air CL.
Butterfly Network’s collaborative initiatives for Butterfly iQ system distribution
Sientra and Butterfly Network partnered to enhance breast implant diagnostic surveillance in patients in April 2021. The partnership enables plastic surgeons to screen and evaluate patients with implants to provide real-time, in-office diagnostic screening, using the Butterfly iQ+ and Ultrasound-on-Chip™ technology.
In November 2021, Abdul Latif Jameel Health and Butterfly Network announced a strategic distribution partnership to bring the Butterfly iQ+ ultrasound device to approximately two billion people in the Middle East, North Africa, Turkey and India.