FDA-regulated AI Algorithms: Trends, Strengths, and Gaps of Validation Studies

FDA-regulated AI Algorithms: Trends, Strengths, and Gaps of Validation Studies

Insufficient public information on validation datasets in several FDA-regulated AI/ML algorithms makes it difficult to justify clinical applications since their generalizability and presence of bias cannot be inferred.

Read the full article at: pubmed.ncbi.nlm.nih.gov

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Omnica Corporation is a privately-held design, engineering, and medical product development firm located in Irvine, California. The 28-person company is staffed with full-time employees and has been in operation since 1984. Our speciality is custom product development for the medical industry and industrial fields.

Our expertise is developing complex medical devices.Technical personnel at Omnica includes designers, mechanical engineers, electronic and software engineers, advanced R&D specialists, regulatory staff (for FDA documentation), machinists and model makers.

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