Lumify Diagnostic Ultrasound System
Philips UltrasoundThe Lumify Diagnostic Ultrasound System by Philips Ultrasound is a transportable ultrasound device that provides high-resolution diagnostic imaging across various modes including B-mode, Doppler, and M-mode. It incorporates an AI-based software feature that automatically detects and quantifies lung B-lines and merged B-lines from ultrasound videos to assist clinicians in assessing lung conditions such as pneumonia and pulmonary edema. The system supports multiple transducers and is designed for use by healthcare professionals in diverse clinical settings.
Intended Use
The Philips Lumify Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined (B+Color), Pulsed Wave Doppler (PWD), and M modes, with applications including lung imaging.
Technology
The system is a mobile, software-controlled ultrasound device compatible with Android and iOS devices, using USB transducers. It incorporates an AI-based machine learning algorithm that analyzes lung ultrasound cine loops to automatically count and detect B-lines and merged B-lines, highlighting them in the images and providing summary outputs to assist clinical workflow.
Performance
Performance testing included non-clinical software verification and a clinical study comparing AI readings to clinician ground truth on 416 lung ultrasound video loops from 157 subjects. The algorithm demonstrated high sensitivity (0.83) and specificity (0.92) for merged B-line detection, and a high intraclass correlation coefficient (0.91) for maximum B-line count, confirming safety and efficacy.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/16/2022
4 months - 2
FDA Approval
5/4/2023
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