In a letter to the company dated April 5, the FDA notified RadLogics that it believes AlphaPoint is being marketed for claims that are not covered by the 510(k) clearance the software received in 2012. The agency said it considers AlphaPoint to be "adulterated" and "misbranded" because the firm does not have a premarket approval (PMA) application to support claims regarding the software's performance.
AlphaPoint's 510(k) clearance describes the product as allowing "review, analysis, and interchange of CT chest images," the FDA noted in its letter. "It is intended for use with CT chest images to assist medical professionals in image analysis. It is not intended to be the primary interpretation."
But RadLogics has exceeded the mandate of that clearance, the FDA believes.
"Your firm's current promotion of the device goes significantly beyond the terms of the clearance and provides evidence that AlphaPoint is being marketed as providing computer-assisted detection (CADe) of abnormalities in radiology images," the letter states.
Specifically, the FDA pointed to language on the company's website indicating that AlphaPoint performs like a "virtual resident" by providing an initial review of radiologic images and generating a report listing and characterizing any abnormalities detected.
The agency also cited a YouTube video posted in November 2017 demonstrating AlphaPoint's CADe functionality and the difference between reading a chest CT and using the RadLogics "machine learning virtual resident."
The FDA believes the statements indicate that RadLogics made a "major change or modification to the intended use" of AlphaPoint, and that the company's claims are not supported in the product's original 510(k) clearance. The agency requested that RadLogics stop marketing AlphaPoint for the CADe functionality described in the letter and take additional corrective action within 15 days.
The company is in the process of responding to the letter, according to CEO Moshe Benjamin.
"The FDA warning letter related to our website showing info on a combination of FDA-cleared as well as non-FDA cleared products in what FDA claimed might mislead potential customers," Benjamin told AuntMinnie.com in an email. "Although our website did have notification relating to non-FDA-cleared products, FDA suggested further clarification. We accepted FDA's request and revised our website accordingly. We also reassured FDA that no non-FDA-cleared products are being marketed by RadLogics in the U.S."
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