Category: Clearances



FDA Clears Servo-air Mechanical Ventilator

Wayne, N.J.-based Getinge announces that the U.S. FDA has cleared its Servo-air mechanical ventilator for use on adult and pediatric patients. The device is slated for availability in the U.S. in late 2020.



VoCare Debuts Mobile Multi-Diagnostic Device

Indiana-based VoCare, Inc. has developed a professional-grade medical diagnostic device that collects six different health vitals and is equipped with WiFi, Bluetooth, and 4G LTE for data transmission, without the need for separate peripherals or an external hub.

FDA Clears Lifetrack PACS

Already deployed in Southeast Asia and South Asia, Lifetrack’s patented platform aims to simplify the deployment of digital radiology, while significantly reducing costs and bringing high quality diagnostic reporting to large, underserved populations.

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FDA Grants PMA to iCAD Tomosynthesis Tool

Nashua, N.H.-based iCAD recently announced that its PowerLook Tomo Detection received FDA premarket approval. PowerLook Tomo Detection is a concurrent-read, computer-aided detection solution for digital breast 3D tomosynthesis and is the latest innovation available on the PowerLook Breast Health Solutions platform.

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