iSono Health makes a wearable ultrasound scanner that images the whole breast automatically in about two minutes, with software to flag suspicious masses, for use outside specialist imaging centres.
iSono Health's ATUSA system is a compact, automated three-dimensional breast ultrasound scanner worn like a bra that captures whole-breast volumes without an operator, connects to a tablet, and uploads images to the cloud where machine-learning software helps identify masses. It is aimed at point-of-care and mobile settings and at women with dense breast tissue for whom mammography is less sensitive. ATUSA has FDA 510(k) clearance for breast imaging; the AI decision-support component and evidence for screening outcomes are at an earlier stage.
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