Spaulding IQ One-Button Handheld ECG Device Receives FDA Approval

Spaulding Clinical Research has received FDA 510(k) approval of their Spaulding IQ foolproof ECG device. It is primarily purposed for centralized ECG collection in clinical trials, the core business of Spaulding Clinical Research. The IQ is a handheld device with a single-button design and a high level of automation. It captures the subject’s voiceprint as a means of biometric identification together with five minutes of ECG recording. Directly after recording, the ECG data, demographic and visit information are sent to the Spaulding Clinical ECG Information System. The high level of automation should reduce errors and allow for data capture in less time and at a lower cost.
Press release: Spaulding Clinical Receives 510k Approval for Proprietary ECG Device…