Spaulding krijgt goedkeuring 510k voor zelfontwikkeld ECG-apparaat
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Spaulding Clinical Research heeft Spaulding IQ ontwikkeld om de farmaceutische klant een betere en efficientere manier te bieden voor het vastleggen van ECG-data. Spaulding IQ is een handbediend apparaat met een intuïtief ontwerp met slechts één knop en is dus zeer eenvoudig te bedienen.
Spaulding Clinical Research kondigt met trots aan een goedkeuring 510k te hebben mogen ontvangen voor hun zelfontwikkelde ECG-apparaat en platform genaamd Spaulding IQ. De Spaulding IQ registreert de stem van de persoon en verbindt deze biometrische informatie onlosmakelijk aan de eropvolgende vijf minuten aan ECG-opnames. Binnen een paar minuten staan de gegevens dan op het Spaulding Clinical ECG Information System.
Engelstalig bericht:
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.â€
“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.
To learn more about how Spaulding IQ could work for your next study, please contact [email protected] or our Sales Office at 415-841-1069. Spaulding Clinical will be demonstrating the IQ device and Protocol from June 19 – 22, 2011 booth 1905 at the DIA meeting in Chicago, IL.
About Spaulding Clinical
Spaulding Clinical (www.spauldingclinical.com) is a Clinical Pharmacology Research Unit and Cardiac Core Lab located in West Bend, Wisconsin offering a full range of services. The company has extensive experience conducting TQT studies, first-in-human studies, multiple rising dose, bioavailability, bioequivalence, drug interaction, and food effect studies. Spaulding Clinical also offers a full suite of Cardiac Core Lab and over-reading services with state-of-the-art technology, equipment and cardiac safety expertise.
