Annalise.ai Builds Momentum in U.S. Market with Seven Additional FDA-Cleared Findings for Imaging Triage and Notification

Key summary

• Annalise.ai has received new 510(k) FDA clearances for seven additional time-critical findings in its chest X-ray (CXR) and non-contrast head CT triage and notification portfolio.

• The latest 510(k) FDA clearances build on Annalise.ai's momentum for expanding into the U.S. market, bringing the total number of U.S.-available findings for its triage and notification products to nine.

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."

Annalise Triage Chest X-ray

Annalise.ai has also expanded its portfolio of FDA 510(k) cleared findings for CADt on CXR to a total of five, and now offers the highest number of findings for triage and notification on chest X-ray in the U.S. market. The findings now include: 

• Pneumothorax
• Tension pneumothorax
• Pleural effusion
• Pneumoperitoneum
• Vertebral compression fracture

As with head CT, quickly identifying imaging findings via CXR can help expedite diagnosis, guide treatment decisions, and improve patient outcomes.

These findings continue the company's momentum in the U.S. which received its first FDA clearance in February of 2022 and now includes a total of nine FDA cleared findings. The first CADt FDA clearance was for the triage and notification of pneumothorax on chest X-ray and was the first product available in the U.S. market to differentiate a tension pneumothorax, allowing a clinical site to apply specific triaging rules for the most urgent tension pneumothorax cases. 

About Annalise.ai

With accelerating advances in medical imaging technology, radiologists and other healthcare providers are now expected to diagnose patients quickly and accurately. Annalise.ai fuses the highest quality imaging data with the very best in computer science to produce comprehensive AI clinical decision support solutions, empowering clinicians to make accurate, faster decisions. Their patient-first approach is proudly clinician-led and comes from a deep understanding of the challenges faced in medical imaging. AI solutions provide clinicians with a second set of eyes, allowing them to detect and protect with confidence and drive better health outcomes for all patients.

Annalise.ai is a joint venture between Australian healthcare technology company Harrison.ai and one of the world's largest radiology companies, I?MED Radiology Network, a partnership that extends the capability of imaging analysis AI to deliver comprehensive modality solutions. The company is located in Australia, the United Kingdom, The Netherlands, and the United States.

THIS PRODUCT IS NOT AVAILABLE FOR PURCHASE BY THE GENERAL PUBLIC

ALWAYS FOLLOW THE INSTRUCTIONS FOR USE

Footnotes and References

(1) https://blog.vrad.com/ed-imaging-demand-skyrocketed-in-2021-and-many-radiology-providers-are-struggling-to-keep-up.-whats-next-for-the-specialty

(2) https://www.stroke.org/en/about-stroke/types-of-stroke/hemorrhagic-strokes-bleeds

SOURCE Annalise.ai