Spaulding Clinical announces 510k approval for ECG device

Leading-edge Clinical Pharmacology and Cardiac Core Lab provider, Spaulding Clinical Research, proudly announces the 510k approval of their proprietary ECG device platform: Spaulding IQ.

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. Within minutes of the recording, the ECG data, demographic and visit information are downloaded to the Spaulding Clinical ECG Information System. Spaulding IQ's automation and integration requires virtually no involvement from the site personnel. This process—named the Mason Protocol after Spaulding Clinical's Chief Medical Officer, Dr. Jay Mason—will provide clients with more data in less time and at a lower cost, with elimination of nearly all opportunities for error.

Dr. Jay Mason commented: "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."

"This is yet another example of Spaulding Clinical keeping true to its mission to deliver higher quality data in less time and at reduced cost. We will always be the innovation leader for our customers," said Randol Spaulding, CEO of Spaulding Clinical.