Spaulding Clinical Research has received 510k approval for its proprietary ECG device platform, Spaulding IQ, according to Fierce BiotechIT.
Spaulding Clinical Research developed Spaulding IQ to provide pharmaceutical clients a better and more efficient way to capture ECG data. Spaulding IQ is a handheld device with an intuitive, single-button design and automation, making it easy to operate and ship.
The Spaulding IQ captures the subject's voiceprint, and that biometric identification is inextricably attached to the subsequent five minutes of ECG recording. The ECG data, demographic and visit information are then downloaded to the Spaulding Clinical ECG Information System. Spaulding IQ's automation and integration requires virtually no involvement from the site personnel. This process will provide clients with more data in less time and at a lower cost, with elimination of nearly all opportunities for error.