AI-guided software for 2D transthoracic echocardiography gains FDA clearance
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Key takeaways:
- An AI-guided ultrasound accessory for 2D-TTE gained FDA clearance.
- The software is designed to assist providers without sonography experience.
UltraSight announced it received FDA 510(k) clearance for its AI-guided ultrasound technology designed to assist providers without sonography experience acquiring point-of-care cardiac ultrasound images.
The software (UltraSight AI Guidance) is indicated for use in 2D transthoracic echocardiography for adult patients for the acquisition of the 10 standard views of the heart, according to a company press release.
When paired with a compatible device — Philips’s ultrasound system (Lumify), for example — the AI neural network is designed to predict the position of the ultrasound probe relative to the heart and guide the user on maneuvering the probe to capture diagnostic cardiac images, the company stated in the release.
The software is designed to assist hospital staff to advance patient triage and treatment and increase access to care for patients with chronic CVD by bringing cardiac ultrasound to local communities, according to the statement.
“Time to clinical decisions and clinical confidence are key aspects in patient care. This is true for people walking into the Emergency Department with acute heart conditions, or patients requiring ongoing monitoring,” Roberto Lang, MD, director of cardiovascular imaging at the University of Chicago, said in the release. “Ultrasound is a predominant tool in patient diagnosis but its user-dependent functionality and subjectivity in image quality assessment have been hurdles in providing care for heart patients in multiple care settings. UltraSight’s real-time AI guidance is a gamechanger for diagnostic efficiency and experience. Now, with regulatory clearance, medical professionals and patients alike can benefit from this transformative cardiac imaging solution.”
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