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July 27, 2018
FDA provides examples of cleared Mobile Medical Apps.
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Software-based medical devices tend to develop more quickly than typical hardware-based medical devices; so, in response, the FDA has turned to an agile regulatory model for software as a medical device (“SaMD”). The FDA describes the Software Precertification Program as a voluntary pathway, with tailored assessments of the safety and effectiveness of software technologies. Rather...
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Dip.io was cleared for clinical urinalysis. The device includes test strips and a color coded card that is readable by smartphone to provide a result for several conditions including infection.
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