FDA clears UltraSight's AI platform for use with a broader range of existing ultrasound devices, aiding novice users in performing echocardiographic exams.
Key Details
- 1UltraSight's AI Echo Stewardship Platform now cleared by FDA for broader ultrasound compatibility.
- 2No new ultrasound equipment is required—compatible with handheld, laptop, and cart-based devices.
- 3Platform provides real-time, AI-assisted guidance for focused cardiac ultrasound (FoCUS) image acquisition.
- 4Aims to reduce variability and improve the usability of cardiac ultrasound by non-sonographer clinicians.
- 5Supports healthcare systems in scaling FoCUS exams without purchasing new hardware.
Why It Matters
By enabling AI-guided echocardiography on existing devices, this clearance lowers adoption barriers, expands cardiac imaging capabilities system-wide, and supports quality imaging by non-experts—potentially easing staff shortages and improving patient care accessibility.
Source
Cardiovascular Business
Related News
•Radiology Business
FDA Approves 56 New AI Radiology Devices, Total Tops 1,000
FDA updates its list with 56 new AI-powered radiology devices, bringing the total to over 1,000 approved tools.
•Radiology Business
a2z Radiology Raises $5M, Lands FDA Clearance for Multi-Condition CT AI
Boston-based a2z Radiology raised $4.5M and earned FDA clearance for its Unified Triage AI solution for abdominal and pelvic CT scans.
•AuntMinnie
AI Ultrasound Tool May Cut Unnecessary Breast Biopsies by 60%
An FDA-cleared AI tool for breast ultrasound may reduce unnecessary biopsies of benign breast lesions by about 60%.