HeartFocus announced today that it began the U.S. commercial launch for its AI-enabled cardiac imaging software on Butterfly Network devices.
DESKi developed the HeartFocus software, earning FDA clearance in April. Now, it’s launching the software on Butterfly Network’s handheld ultrasound devices.
The software enables any healthcare professional to conduct diagnostic-quality heart ultrasounds after just hours of training. Health systems, primary care clinics, and clinical education institutions can now access the application.
After the spring FDA clearance and a successful international clinical trial, HeartFocus moves from pilot to full deployment. It aims to address barriers in cardiac care like limited access to trained sonographers and long wait times for diagnostic imaging. Within hours of training, any healthcare professional using HeartFocus can capture comprehensive echocardiographic views.
Now, the company offers the software through the Butterfly Network single-probe, whole-body ultrasound system with seamless AI integration. Butterfly offers the latest-generation, semiconductor-based iQ3 device. It features a brand-new ergonomic design and provides double the data processing speed compared to previous generations, according to the company. The FDA cleared the iQ3 system in January and it now has CE mark approval in Europe.
This launch comes as part of the Butterfly Garden AI marketplace.
“With HeartFocus, we’re unlocking access to life-saving heart scans wherever they’re needed most,” said DESKi CEO Dr. Bertrand Moal. “This isn’t just a product launch, it represents phase one in our mission to transform how and where cardiac care is delivered, setting a new standard in accessibility and impact.”
