FDA Grants 501(k) to Two Avicenna.AI Products

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FDA continues to clear AI solutions.

Avicenna.AI announced that FDA granted 510(k) clearance for two of its AI products, according to a press release.¹ Both the CINA-iPE and CINA-ASPECTS are designed to be incorporated into the workflow of radiologists.

In a press release, Avicenna.AI’s clinical affairs manager Yasmina Chaibi said, “From day one, we have been committed to validating our AI tools on every type of CT scanner. In our validation studies, CINA-iPE achieved excellent sensitivity and specificity, demonstrating its ability to provide effective prioritization and triage on routine CT scans performed for other clinical indications than pulmonary embolism suspicion."

Chaibi continued, “The validations and multi-reader-multi-case studies we conducted highlighted that CINA-ASPECTS not only obtained outstanding standalone performance, but also demonstrated that its adjunctive use significantly improved clinicians' accuracy in the assessment of ASPECTS regions, compared to the conventional use of NCCT images alone.”

The CINA-iPE uses AI-powered technology to detect incidental pulmonary embolism during CT scans. According to Avicenaa.AI’s release, unsuspected pulmonary embolisms may commonly be found during routine scans, but only about 25% of emboli are reported during the initial reports. The program is also capable of detecting lung blood clots, even during unrelated scans.

CINA-ASPECTS uses AI technology to assess stroke severity. It is able to scan non-contrast CT scans and uses a topography scoring system to determine its results. It is also capable of correcting CT images distorted by tilt and can compare the left and right hemispheres of the brain.

The tool is also designed to help conform readings and scorings from CT scans, which can vary from radiologist to radiologist. By using quantifiable elements, it is able to provide direct and reproducible results.

In the same press release, Avincenna.AI’s regulatory and quality manager Stephane Berger said, “We are delighted to launch CINA-ASPECTS to the US market, marking a significant milestone as our first CADx product receives FDA clearance. We take pride in being at the forefront of CADx solutions, being the first AI company supported by thorough clinical validation and a rich repository of real-world clinical data, which ensures compatibility across all manufacturers and platforms."

The ability to bring regularity and conformity to testing results is one of the top reasons why AI is being embraced by the pharmaceutical industry. Testing, whether it’s in a clinical trial or live setting, often relies on a certain amount of interpretation by medical practitioners. Two different HCPs may come to different conclusions based on the same test results.

AI-based technology helps bridge that gap. Typically, these programs don’t report conclusions, but instead quantify the data in ways that help bring different HCPs to similar conclusions. This still allows for human workers to use their expertise when looking at test results, but also to do so in a way where the data is presented in a more direct way.

Source

1. Avicenna.AI Secures FDA Clearance for Two Healthcare AI Solutions. Avicenna.AI. March 26, 2024. Accessed March 28, 2024. https://www.prnewswire.com/news-releases/avicennaai-secures-fda-clearance-for-two-healthcare-ai-solutions-302099611.html