Michael Barbella, Managing Editor06.06.23
Annalise.ai has received U.S. Food and Drug Administration (FDA) 510(k) clearance covering an additional seven findings as part of the company’s 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.
Although medical imaging in the U.S. declined during the pandemic, there has been a rapid rebound in imaging volumes to higher-than pre-pandemic levels1 amidst a shrinking radiology workforce and increasing rates of physician burnout.
“AI-assisted triage is becoming increasingly important in healthcare,” Annalise.ai Chief Medical Officer Rick Abramson, M.D., said. “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 United States, 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:
“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,” Annalise.ai CEO Lakshmi Gudapakkam stated. “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-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:
These findings continue the company’s momentum in the U.S., which received its first FDA clearance in February 2022 and now includes a total of nine cleared findings from the agency. 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.
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 AI clinical decision support solutions, empowering clinicians to make accurate, faster decisions. Its patient-first approach is 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 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.
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
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.
Although medical imaging in the U.S. declined during the pandemic, there has been a rapid rebound in imaging volumes to higher-than pre-pandemic levels1 amidst a shrinking radiology workforce and increasing rates of physician burnout.
“AI-assisted triage is becoming increasingly important in healthcare,” Annalise.ai Chief Medical Officer Rick Abramson, M.D., said. “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 United States, 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
“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,” Annalise.ai CEO Lakshmi Gudapakkam stated. “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-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
These findings continue the company’s momentum in the U.S., which received its first FDA clearance in February 2022 and now includes a total of nine cleared findings from the agency. 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.
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 AI clinical decision support solutions, empowering clinicians to make accurate, faster decisions. Its patient-first approach is 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 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.
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