Automated point-of-care ultrasound advances
- RIVANNA expanded a multi-site study for its Accuro XV portable volumetric musculoskeletal ultrasound with AI-assisted acquisition. - DeepEcho’s Blind Sweep platform earned FDA Breakthrough Device designation for automated prenatal ultrasound measurements. - Both moves show regulator and vendor interest in automating image capture where operator skill is scarce, potentially expanding bedside imaging roles ( ).
Ultrasound is turning into more of a guided scan and less of a specialist craft as two companies push software that helps users capture images at the bedside. RIVANNA said on April 22 it expanded an Accuro XV study from two sites to eight, and DeepEcho said on March 25 that the Food and Drug Administration gave its Blind Sweep prenatal platform Breakthrough Device designation. (rivannamedical.com) (fda.gov) (diagnosticimaging.com) Point-of-care ultrasound is the small, portable version of ultrasound used in emergency departments, clinics, and hospital rooms to answer quick questions in real time. A 2024 review said artificial intelligence tools are being built to guide image acquisition, improve image quality, and label anatomy because scan quality still depends heavily on operator skill. (springer.com) RIVANNA’s Accuro XV is a portable volumetric musculoskeletal ultrasound system with a conformable three-dimensional probe designed to automate large-field B-mode image capture without ionizing radiation. The company said the expanded study follows a Biomedical Advanced Research and Development Authority funding option and is aimed at developing an automated fracture-detection algorithm while compressing its anticipated Food and Drug Administration 510(k) timeline. (rivannamedical.com) RIVANNA launched its first multi-site first-in-human Accuro XV study in October 2024 with a planned 200 participants to test safety, emergency-department workflow, and automated diagnostic imaging for fractures. The April 2026 update moves that work from two sites to eight sites nationwide. (prnewswire.com) (rivannamedical.com) DeepEcho’s Blind Sweep platform uses simple protocol-based sweeps to collect standard B-mode ultrasound videos on handheld or cart-based machines, then software calculates measurements. DeepEcho said the system automates readings for fetal presentation, placental location, amniotic fluid, fetal heart rate, gestational age, and estimated fetal weight. (accessnewswire.com) (diagnosticimaging.com) The Food and Drug Administration’s Breakthrough Devices Program is a premarket program, not a marketing clearance or approval. The agency says the designation gives companies more interaction with reviewers and prioritized review, but devices still must meet the usual standards for safety and effectiveness before they can be marketed. (fda.gov) Both products target the same bottleneck: ultrasound often works best when an experienced operator knows exactly where to place the probe and how to angle it. Reviews published in 2024 and 2025 said artificial intelligence could expand point-of-care ultrasound by assisting acquisition and interpretation, but they also flagged concerns about bias, trustworthiness, and real-world validation. (springer.com) (ncbi.nlm.nih.gov) That bottleneck is not just technical. A recent Journal of Ultrasound in Medicine study reported a U.S. sonographer shortage, with ultrasound exam demand rising faster than the pipeline of graduates. (colab.ws) The near-term test is whether automated capture can hold up across many clinics, many users, and many patient types. For now, one company is collecting more multi-site fracture data and the other has won a faster lane for regulatory discussions in prenatal imaging. (rivannamedical.com) (fda.gov)
