New York, 2nd August, 2024 – Leading radiology AI provider Annalise.ai has announced that it has secured a Medicare New Technology Add-on Payment (NTAP) from the Centers for Medicare & Medicaid Services (CMS) for the use of Annalise – Obstructive Hydrocephalus, part of the Annalise Critical Care AI solution, to triage non-contrast brain CT scans suspected of obstructive hydrocephalus (OH). In approving the payment, CMS recognized the device’s substantial clinical improvement over existing services, consistent with a Breakthrough Device Designation awarded to the technology by the Food and Drug Administration.
Annalise.ai’s solution is now the only radiology AI triage device in the US eligible for separate, additional Medicare hospital payment. This innovation triages non-contrast brain CT scans suspected of obstructive hydrocephalus (OH). Obstructive hydrocephalus is a life-threatening condition involving the build-up of cerebrospinal fluid (CSF) in the brain and can be fatal if not detected and treated urgently.
Prompt diagnosis of OH can be challenging as its clinical presentation often overlaps with other neurological conditions. Furthermore, when coupled with delays in the diagnostic imaging workflow, the time to diagnose OH and communicate results to care teams may be adversely impacted.
The Annalise.ai solution addresses these challenges by identifying non-contrast brain CTs with findings suggestive of obstructive hydrocephalus within minutes of the scan. It flags these cases in the radiologist’s worklist and alerts managing clinicians, supporting faster diagnosis and treatment. The solution demonstrates excellent performance with an AUC of 0.987, and sensitivity and specificity up to 97.5% and 95.3% respectively1.
Dr. Aaron Yengo-Kahn, neurosurgeon in Orange, CA said, “Patients with obstructive hydrocephalus can deteriorate rapidly if not promptly identified, evaluated, and treated. Annalise – OH will help care teams identify these patients faster, consult with their neurosurgeon, and reduce the chance that they suffer from severe complications.”
Obstructive hydrocephalus is one of 12 FDA-cleared urgent findings that comprise Annalise Critical Care AI, the most comprehensive AI triage solution for chest X-ray and non-contrast head CT available in the US2.
Dr. Aengus Tran, co-founder and CEO of Annalise.ai, stated, “Annalise Critical Care AI has garnered significant interest due to its clinical capabilities. With the introduction of additional Medicare payments, we anticipate more adoption of our technology by hospital systems, improving patient outcomes.”
Since 2001, CMS have offered manufacturers of new, groundbreaking technologies the ability to apply for an NTAP designation for their drug, device, or diagnostic that will provide hospitals with extra payments when they use the product for the two or three years after its market entry in order to broaden access for Medicare patients. Beginning with applications for FY 2021, CMS provides an alternative approval pathway to secure an NTAP for medical devices designated under FDA’s Breakthrough Devices Program. Breakthrough technologies, such as Annalise.ai’s, are assumed to meet CMS’s newness and substantial clinical improvement criteria, and must demonstrate inadequate payment to meet the cost criterion.
- Data on file, Manuscript in preparation
- FDA website as of July 2024
Press Contact for Annalise.ai
Reena.rajan@annalise.ai
