DeepLook Gets FDA Clearance for Imaging Software

July 12, 2021

Medical device software developer DeepLook has received the FDA’s 510(k) clearance for DL Precise, a software tool for highlighting suspicious objects in medical images.

The software automates the measurement of suspicious objects in a range of medical images using “deterministic algorithms” — algorithms which, given a particular input, will always produce the same output — that outline the contours of an object, as well as measuring its area and estimated volume.

DL Precise is the first of a series of medical imaging products under development by the New Haven, Conn.-based company.

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