BOSTON, June 22, 2026 (GLOBE NEWSWIRE) — GuideAI Health Corp. (“GuideAI” or the “Company“) is pleased to announce that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for VascularAssist Occlusion Triage (VAOT), the Company’s artificial intelligence software designed to support the prioritization and triage of vascular occlusion in the lower extremities.
VAOT is a Class II, AI-based Software as a Medical Device (SaMD) operating as a Computer-Aided Triage and Notification device (CADt). The software assists radiologists in identifying and characterizing significant peripheral vascular disease (PVD)—a leading contributor to both acute and chronic limb ischemia, by flagging suspected vascular occlusion for prioritized review within existing imaging workflows. By surfacing high-priority cases earlier, VAOT is designed to help clinical teams reduce time to diagnosis and intervention for patients at risk of limb-threatening disease.
In clinical performance testing supporting the clearance, VAOT demonstrated strong accuracy in identifying disease at the patient level, achieving 95% patient-level sensitivity (2D analysis) / 94% patient-level sensitivity (3D analysis) for identifying Peripheral Artery Disease-positive patients — defined as patients with at least one lesion at 50% or greater stenosis.
“Receiving FDA 510(k) clearance for VAOT is a defining milestone for GuideAI and for the patients we ultimately aim to serve,” said Raj Shah, MD, MBA, Chief Executive Officer of GuideAI Health. “Peripheral vascular disease is too often missed or detected late, with devastating consequences. VAOT brings AI-powered triage directly into the radiology workflow, helping clinicians identify vascular disease sooner so patients can be directed to the right care faster. This clearance marks the first step in our broader vision to set a new standard in AI-driven vascular care.”
About GuideAI Health Corp.
GuideAI Health Corp. is a healthcare technology company using artificial intelligence to enable the early detection of vascular disease and support more precise treatment decisions. Its platform analyzes routine CT scans to identify peripheral vascular disease and other vascular conditions that are frequently missed or under-reported, generating structured, actionable reports for radiologists and treating clinicians. By surfacing disease earlier and matching findings to appropriate treatment pathways, GuideAI aims to improve patient outcomes while helping hospitals and radiology groups deliver more comprehensive vascular care.
On Behalf of the Board of Directors:
GUIDEAI HEALTH CORP.
Raj Shah
Chief Executive Officer
For further information, please contact:
Phone: (416) 309-3583
Email: info@guideaihealth.com
Cautionary Note Regarding Forward-Looking Statements
This news release contains certain “forward-looking statements” and “forward-looking information” within the meaning of applicable Canadian securities laws. Forward-looking statements include, but are not limited to, the intended design and use of VAOT and the Company’s vision. These statements are based on assumptions and expectations that management considers reasonable as of the date of this release.
Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause actual results, performance, or achievements to differ materially from those expressed or implied. Such factors include, among others, the risks described in the Company’s public disclosure documents available under its profile on SEDAR+ at www.sedarplus.ca. Readers are cautioned not to place undue reliance on forward-looking statements. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.
