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ABSTRACT: Background
Artificial intelligence (AI) enables remote patient monitoring (RPM) which reduces costs by triaging patients to optimize hospitalization and avoid complications. The FDA regulates AI in medical devices and aims to ensure patient safety, effectiveness, and transparent AI solutions.Objectives
Identify and summarize FDA approved RPM devices to provide information for the US medical device industry based on previous approvals and the markets' needs.Methods
We searched publicly available databases on FDA-approved RPM devices. Selection criteria were established to classify a solution as AI. Technical information was analyzed on pre-identified 16 parameters for the qualified solutions.Results
A total of 47 RPM devices were reviewed, among which 12.8% w
SUBMITTER: Dubey A
PROVIDER: S-EPMC10158563 | biostudies-literature | 2023
REPOSITORIES: biostudies-literature