Vitalograph has received FDA approval for the In2itive e-Diary spirometer and is now available for global clinical trials including the USA.
This next-generation In2itiveTM e-Diary combines in-clinic spirometry, home monitoring of respiratory endpoints, and eCOA data gathering functions in a single, robust, handheld medical device.
New features include:
- Large, high resolution, highly responsive, fast touch screen with clear text, a training module and live spirometry quality feedback making the device easy to use and promoting high quality and reliable data.
- Alerts, reminders and workflows are fully customizable to fit study protocols.
- Automatic end-to-end secure data transmission.
Fully integrated wireless communications (WiFi, Cellular/Mobile and Bluetooth) allows automatic, secure, transmission of data to the study web portal for instant review. Real-time insight into site and subject performance. The In2itive e-Diary is a fully validated class II medical device that meets or exceeds all technical requirements for cyber-security and data protection.
The new device also meets the performance requirements of ISO 23747 (peak flow), ISO 26782 (volumes) and the ATS/ERS joint 2019 statement on the standardization of spirometry.
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