FDA approves DeepBreeze pulmonary imaging device

The company already has marketing approval for its system in Israel, Europe, and South Korea.

DeepBreeze Medical Devices Ltd. has obtained US Food and Drug Administration (FDA) marketing approval for its pulmonary imaging device, Vibration Response Imaging (VRIxp). The company already has marketing approved for the device in Israel, Europe, and South Korea.

DeepBreeze does not disclose its sales figures, but says that it has already installed the VRIxp at leading medical centers in Europe and Asia. The company’s next challenge is to obtain insurance reimbursement for tests using the system.

DeepBreeze president and CEO Dr. Igal Kushnir says that the company began setting up its international marketing network in advance, and that it has already installed the VRIxp for trials at several leading US medical centers. The company will therefore be able to begin marketing immediately to target markets which do not require medical reimbursement.

DeepBreeze’s technology images the lungs without using radiation, using instead acoustic signals (infrasound vibration) created by the lungs during breathing. Sensors placed on the patient’s back pick up these vibrations. The procedure merely requires the patient to breath normally for several seconds, and an image is built up on a computer screen and changes as the patient breathes.

According to IVC Online, DeepBreeze has raised $36 million today date from Aviv Venture Capital, Vitalife Life Sciences Venture, Nisko Industries Ltd., Union Investments and Enterprises (UIE) Ltd., SCP Private Equity Partners, and Kreos Capital.

Published by Globes [online], Israel business news - www.globes.co.il - on July 24, 2007

© Copyright of Globes Publisher Itonut (1983) Ltd. 2007

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