May 13, 2022 — Median Technologies announced that the company has received feedback from the United States Food and Drug Administration (FDA) regarding the 513(g) submission done on Feb. 17, 2022 for its iBiopsy Lung Cancer Screening (LCS) AI/ML technology-based end-to-end CADe/CADx1 Software as Medical Device (SaMD).
The aim of the 513(g) submission was to determine the relevant product classification and choose between the De Novo or the 510(k) regulatory pathways2 for iBiopsy LCS CADe/CADx SaMD. The FDA has stated that the Median’s iBiopsy LCS CADe/CADx falls within 21 CFR 892.2090 (Radiological Computer Assisted Detection And Diagnosis Software), a Class II type device, which requires the submission of a 510(k) in order to obtain the FDA clearance prior to marketing.
As next regulatory steps, Median Technologies is preparing several Q-submissions for Q2 and Q3, 2022. The first Q-sub has been submitted for FDA review on May 2, and focuses mostly on reviewing pivotal study protocols and possible predicate devices. A meeting will be scheduled with the FDA experts at their earliest convenience.
“After this first regulatory feedback of the FDA on the 513(g), we want to keep having frequent and fruitful interactions with the Agency in order to better tailor our device to the US market”, Fredrik Brag, CEO and founder of Median Technologies said. “The design of the pivotal studies will be a key part of showing the unique performance of our iBiopsy CADe/CADx Software as Medical Device and how it could have an impact on saving patients’ lives by identifying lung cancer onsets at their earliest stage”, Brag added.
For more information: www.mediantechnologies.com
1 A radiological CADe device is “intended to identify, mark, highlight or otherwise direct attention to portions of an image that may reveal abnormalities during interpretation of images by the clinician.” A CADx device is “intended to provide information beyond identifying abnormalities, such as an assessment of disease.” Source: FDA
2 510(k) and De Novo pathways are the only regulatory pathways available to bring a device of low to moderate risk level on the US market. Compared to the traditional 510(k), the De Novo classification is a risk-based classification process which is allowed for devices which have not filled the conditions to be submitted via a 510(k). Source: FDA