White paper

Imaging with Integrity: Committing to Cleaner Ultrasound Technology

For many years, traditional ultrasound equipment has relied on the use of lead-based piezoelectric crystals to deliver high-quality imaging. Piezoelectric crystals contain up to 65% lead1—well above the 0.1% limit set by the European Union’s Restriction of Hazardous Substances (RoHS) directive.

With the introduction of cleaner technologies, that status quo is shifting. Now, it’s possible to meet international standards for the presence of lead, without compromising on image quality. However, legacy ultrasound manufacturers, which have sidestepped RoHs requirements via exemptions, continue to claim there is no viable alternative. Now, with these exemptions for renewal in 2025, it’s time to reexamine compliance through a new lens of accountability
and transparency.

Butterfly Network is leading this charge, and we call on healthcare providers to join us. Read on to learn how new imaging alternatives that don’t rely on lead are the future of ultrasound technology.

The hidden risks of lead in ultrasound technology

Piezoelectric crystals, including lead zirconate titanate (PZT), are used to deliver high-quality ultrasound images. Unfortunately, PZT’s strong piezoelectric properties come at a cost: a significant amount of lead. Lead is a hazardous substance linked to multiple health issues, including potential organ damage, fertility complications, and developmental risks in children. In fact, the risks of lead exposure occur at every stage of a device’s lifecycle:

  • Mining and manufacturing: The extraction and production of lead-based components disproportionately affect low-income regions, exposing local communities to long-term environmental and health risks.
  • End-of-life disposal: Once these lead-containing devices reach the end of their lifecycle, they enter the medical waste stream, where safe disposal practices are often unclear or insufficient.

1 in 3 healthcare facilities lacks sufficient waste management systems, according to The World Health Organization.2

The shift to a cleaner future: Butterfly’s iQ3 ultrasound

Butterfly Network developed the first commercially available, whole-body single-probe handheld ultrasound device that meets RoHS standards without relying upon the exemption permitting lead, found in piezoelectric crystals that most traditional ultrasound systems rely upon. The iQ3 delivers image quality comparable to—or even better than—traditional ultrasound devices, while containing less than 0.1% lead.3

Powered by our Ultrasound-on-Chip™ technology, the iQ3 uses capacitive micromachined ultrasonic transducers (CMUTs), which integrate thousands of transducer elements directly atop the circuits controlling them at the wafer level. This innovation packs massive processing power into a chip the size of a postage stamp, without the need for piezoelectric crystals or lead. The iQ3 complies with RoHS regulations, offering healthcare providers a high-quality alternative for handheld ultrasound.

Breaking the industry’s dependence on exemptions

While Butterfly has led the charge in creating a safer, more sustainable ultrasound solution, many legacy ultrasound manufacturers continue to rely on exemptions to avoid RoHS compliance. They do so with support from COCIR, the powerful lobby representing the EU medical device industry. This means that these companies can retain their CE-mark, which permits their products to be sold in the EU, despite having lead levels far above the RoHS limit.

Even more troubling: Manufacturers are not required to disclose the lead content in their devices. This lack of transparency leaves healthcare providers and patients unaware of potential safety and environmental risks. Providers deserve to know exactly what’s in the devices they use every day.

Exemptions also create a ripple effect that limits innovation across the healthcare sector. Allowing manufacturers to bypass RoHS standards via exemptions stalls the development and adoption of cleaner, more environmentally friendly ultrasound technology. Healthcare providers should have the freedom to choose the devices that best meet the needs of their patients and community.

What concerns me most about these exemptions is that healthcare systems, providers, and patients remain in the dark about the lead content in ultrasound devices—content that exceeds environmental standards.

Joe DeVivo
Butterfly Network President and CEO

Driving sustainable innovation in ultrasound

At Butterfly Network, we’re revolutionizing medical imaging to benefit patients, providers and the planet. The iQ3 ultrasound probe is a prime example of our focus on safety and sustainability. Its design reduces environmental impact while meeting the growing demand for more responsible healthcare practices.

The iQ3 offers a powerful handheld POCUS solution for healthcare organizations that want to boost their environmental responsibility without compromising on care quality. From recyclable design components and packaging, to responsible component sourcing, we prioritize sustainability at every step.

Our innovation extends beyond the device itself. The iQ3 seamlessly integrates into clinical workflows through Butterfly’s cloud-based software, including Compass—our device-agnostic middleware. This integration allows healthcare providers to connect ultrasound devices to Electronic Health Records and Picture Archiving and Communication Systems, regardless of manufacturer, improving accessibility and interoperability.

Our all-digital solution enables easy updates, while our middleware ensures a seamless workflow across both new and existing ultrasound units.

A vision for a cleaner future

We envision a future where ultrasound is safer for patients, clinicians, and the planet.
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The expiration of RoHS exemptions in 2025 presents a pivotal opportunity to move away 
from lead-based technologies and adopt cleaner, safer alternatives. By reducing lead dependence, Butterfly is challenging the ultrasound industry to prioritize patient and environmental safety. Given the well-documented risks of lead, we must do better—
for patients, providers and the planet.

Step into the new era of medical imaging.

Learn how to adopt cleaner handheld ultrasound technology in your organization.

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