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Annalise.ai builds momentum in U.S. market with seven additional FDA-cleared findings for imaging triage and notification

Press releases may be edited for formatting or style | April 12, 2023 Artificial Intelligence X-Ray
SYDNEY, April 12, 2023 /PRNewswire/ -- Annalise.ai, the global radiology AI company, announced today that it has received FDA 510(k) clearances covering an additional seven findings as part of the company's innovative AI-assisted triage and notification (CADt) solutions. The clearances, including a suite of time-sensitive stroke findings and an expansion of findings for chest X-ray, build on Annalise's momentum and growth strategy in the U.S. market.

Annalise Triage uses deep learning to identify the suspected presence of time-sensitive pathologies and flag priority cases within the radiology worklist, assisting the care team in treating patients with the most critical conditions first.

Global Context
Although medical imaging in the U.S. declined during the pandemic, there has been a rapid bounce back in imaging volumes to higher-than pre-pandemic levels (1) amidst a shrinking radiology workforce and increasing rates of physician burnout.

"AI-assisted triage is becoming increasingly important in healthcare," said Rick Abramson, MD, MHCDS, FACR, Annalise.ai's Chief Medical Officer. "Triage solutions drive quality improvement by enabling earlier detection and intervention for our most critically ill patients. And by prioritizing the radiology worklist, these solutions also help address some of the burnout issues that have affected our specialty since the pandemic."

All FDA-cleared Annalise CXR and CT Brain findings are a subset of a comprehensive group of solutions, field-tested and available outside the U.S., with clinical studies showing improvements in detection accuracy, diagnostic decision-making, and reporting speed.

Annalise Triage CT Brain

The latest 510(k) cleared findings for use in triage and notification (CADt) for CT Brain are:

Acute subdural/epidural hematoma
Acute subarachnoid hemorrhage
Intra-axial hemorrhage
Intraventricular hemorrhage

According to the American Stroke Association, cerebral hemorrhage accounts for approximately 13 percent of all strokes in the United States, with an estimated 41,000 cases occurring each year. (2) Triaging specific subtypes of brain hemorrhage is important because each type has its own specific causes, symptoms, and treatments.

"We are thrilled to mark our entry into the U.S. neuroimaging space with this set of high-precision tools for prioritizing intracranial hemorrhage cases on non-contrast head CT," said Lakshmi Gudapakkam, CEO of Annalise.ai. "Annalise.ai is committed to developing the highest quality tools for advancing patient care and patient care efficiency in the U.S."

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