Vitalograph has received FDA 510(k) clearance for its new In2itive e-Diary spirometer, which is now available for clinical trials in the US, the company announced.
The next generation In2itive e-Diary combines in-clinic spirometry, home monitoring of respiratory endpoints, and eCOA data gathering functions in a robust, handheld medical device.
New features include:
- Large, high resolution touch screen with clear text, animated training module and live spirometry 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 GSM module allows automatic, secure, transmission of data to the study web portal for instant access enabling 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.
Vitalograph is a world leading provider of outstanding quality cardio-respiratory diagnostic devices, clinical trial services and medical equipment servicing. With a pioneering heritage of excellence spanning half a century Vitalograph continues to make valuable contributions to effective medical care and enhanced quality of life.
More information is available on the company’s website.
