iSono Health announced the FDA clearance of its ATUSA automated wearable 3D breast ultrasound system, a first-of-its-kind device that taps into some of the biggest trends in imaging.
The wearable ATUSA system automatically captures the entire breast volume, producing standardized/repeatable breast ultrasound exams in two minutes without requiring a trained operator. The scanner combines with iSono’s ATUSA Software Suite to support real-time 2D visualization, advanced 3D visualization and localization, and AI integration (including iSono’s forthcoming AI tools). That positions the ATUSA for a range of interesting use cases:
- Enhancing routine exams in primary care and women’s health clinics
- Expanding breast imaging access in developing countries
- Supporting longitudinal monitoring for higher-risk women
- Allowing remote breast cancer monitoring
iSono might have to overcome some pretty big biases regarding how and where providers believe breast exams are supposed to take place. However, the ATUSA’s intended use cases and value propositions have already been gaining momentum across imaging.
- The rapid expansion of handheld POCUS systems and AI guidance solutions has made ultrasound an everyday tool for far more clinicians than just a few years ago.
- Wearable imaging continues to be an innovation hotspot, including a range of interesting projects that are developing imaging helmets, patches, and even a few other wearable breast ultrasound systems.
- There’s a growing focus on addressing the developing world’s imaging gap with portable imaging systems.
- We’re seeing greater momentum towards technology-enabled enhancements to routine breast exams, including Siemens Healthineers’ recent move to distribute UE LifeSciences’ iBreastExam device (uses vibrations, not imaging).
- At-home imaging is becoming a far more realistic idea, with commercial initiatives from companies like Butterfly and Pulsenmore in place, and earlier-stage efforts from other breast ultrasound startups.
iSono Health has a long way to go before it earns an established role in breast cancer pathways. However, the ATUSA’s use cases and value proposition are well aligned with some of imaging’s biggest trends, and there’s still plenty of demand to improve breast imaging access and efficiency across the world.