Today, the U.S. Food and Drug Administration authorized marketing of software to help medical professionals who examine body tissues (pathologists) within the detection of areas that are suspicious for cancer as an adjunct (supplement) to the review of digitally-scanned slide images from prostate biopsies (tissue faraway from the body). The software, called Paige Prostate, is that the first AI (AI)-based software designed to spot a neighborhood of interest on the prostate biopsy image with the very best likelihood of harboring cancer so it are often reviewed further by the pathologist if the world of concern has not been identified on initial review.
“Pathologists examine biopsies of tissue suspected for diseases, like prostatic adenocarcinoma , every day. Identifying areas of concern on the biopsy image can help pathologists make a diagnosis that informs the acceptable treatment,” said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health within the FDA’s Center for Devices and Radiological Health. “The authorization of this AI-based software can help increase the amount of identified prostate biopsy samples with cancerous tissue, which may ultimately save lives.”
Cancer that starts within the prostate is named prostatic adenocarcinoma . consistent with the Centers for Disease Control and Prevention, apart from non-melanoma carcinoma , prostatic adenocarcinoma is that the commonest cancer among men within the us . it’s also one among the leading causes of cancer death among men.
Paige Prostate is compatible to be used with slide images that are digitized employing a scanner. The digitized slide image can then be visualized employing a slide image viewer.
The FDA evaluated data from a clinical study where 16 pathologists examined 527 slide images of prostate biopsies (171 cancer and 356 benign) that were digitized employing a scanner. for every slide image, each pathologist completed two assessments, one without Paige Prostate’s assistance (unassisted read) and one with Paige Prostate’s assistance (assisted read). While the clinical study didn’t evaluate the impact on final patient diagnosis, which is usually supported multiple biopsies, the study found that Paige Prostate improved detection of cancer on individual slide images by 7.3% on the average in comparison to pathologists’ unassisted reads for whole slide images of individual biopsies, with no impact on the read of benign slide images.
Potential risks include false negative and false positive results, which is mitigated by the device’s use as an adjunct (e.g., the device assists pathologists reviewing slide images) and by the professional evaluation by a professional pathologist who takes under consideration patient history among other relevant clinical information, and who may perform additional laboratory studies on the samples before rendering a final diagnosis.
The FDA reviewed the device through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a replacement type. along side this authorization, the FDA is establishing special controls for devices of this sort , including requirements associated with labeling and performance testing. When met, the special controls, along side general controls, provide reasonable assurance of safety and effectiveness for devices of this sort . This action creates a replacement regulatory classification, which suggests that subsequent devices of an equivalent type with an equivalent intended use may undergo FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.FDA reviewed the device through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a replacement type. the FDA is establishing special controls for devices of this sort ,whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device
The FDA granted marketing authorization of the Paige Prostate software to Paige.AI.
Source link: https://www.fda.gov/