Spaulding Clinical Research has received the 510k approval for their proprietary ECG device platform - Spaulding IQ.
Spaulding Clinical Research developed Spaulding IQ to provide pharmaceutical clients a better and 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 device captures the subject’s voiceprint, and that biometric identification is inextricably attached to the subsequent five minutes of ECG recording.
Spaulding IQ’s automation and integration requires virtually no involvement from the site personnel.
Spaulding Clinical chief medical officer Jay Mason said the greatest value of this new process is that it makes it logistically and financially feasible to collect very high-quality, centralized ECG information in virtually all clinical trials.
"This will greatly improve subject safety during trials and drug safety in the marketplace. Pharmaceutical Sponsors will gain the ability to make earlier, better-informed drug development decisions," Mason said.