Social & Scientific Systems Uses HeartSignals to Submit HL7 QT Data Sets to 2013 FDA ECG Warehouse
Silver Spring, MD, May 30, 2013 --(PR.com)-- Social & Scientific Systems, Inc. (SSS), a clinical research services provider focusing on both the government and commercial sectors, announced today that SSS' Cardiac Core Laboratory Services HeartSignalsTM system has been formally validated by the U.S. Food and Drug Administration (FDA) to receive electronic HL7-format data submissions into the 2013 FDA digital ECG Warehouse. The Agency's test certification data set represented five different vendor device formats, including:
1. GE Mac1200 ECGs (bedside diagnostic cart), processed on the GE MUSE Cardiology Information System
2. Mortara Eli250 ECGs (bedside diagnostic cart), processed on the Mortara E-Scribe Rx system
3. Philips PageWriter Touch ECGs (bedside diagnostic cart) in HL7 format
4. Mortara Surveyor ambulatory ECGs (telemetry-extracted), generated on the E-Scribe Rx
5. Mortara H12+ ambulatory ECGs (Holter-extracted), generated on the HScribe system
The validation is for the latest 2013 FDA ECG Warehouse software version.
SSS Medical Director Jean T. Barbey, MD, stated, “We are delighted but not surprised that our HeartSignals technology enabled us to formally submit ECG data error free to the FDA Warehouse on our first attempt. Our system architect's deep understanding of the HL7 regulations ensured that we did not have to rely on expensive third-party solutions to achieve this goal.”
About Social & Scientific Systems, Inc.
Social & Scientific Systems, Inc. (SSS) is an employee-owned public health research organization with a mission to improve public health worldwide. The company provides support for the public and private sectors in the areas of public health and international development. SSS has offices in Silver Spring, Maryland; Durham, North Carolina; Jakarta, Indonesia; Kigali, Rwanda; and Kampala, Uganda. For more information about Social & Scientific Systems Cardiac Core Lab Services, please contact Stephanie Nealis at snealis@s-3.com.
For More Information Contact
Stephanie Nealis
301-628-3000
SNealis@s-3.com
1. GE Mac1200 ECGs (bedside diagnostic cart), processed on the GE MUSE Cardiology Information System
2. Mortara Eli250 ECGs (bedside diagnostic cart), processed on the Mortara E-Scribe Rx system
3. Philips PageWriter Touch ECGs (bedside diagnostic cart) in HL7 format
4. Mortara Surveyor ambulatory ECGs (telemetry-extracted), generated on the E-Scribe Rx
5. Mortara H12+ ambulatory ECGs (Holter-extracted), generated on the HScribe system
The validation is for the latest 2013 FDA ECG Warehouse software version.
SSS Medical Director Jean T. Barbey, MD, stated, “We are delighted but not surprised that our HeartSignals technology enabled us to formally submit ECG data error free to the FDA Warehouse on our first attempt. Our system architect's deep understanding of the HL7 regulations ensured that we did not have to rely on expensive third-party solutions to achieve this goal.”
About Social & Scientific Systems, Inc.
Social & Scientific Systems, Inc. (SSS) is an employee-owned public health research organization with a mission to improve public health worldwide. The company provides support for the public and private sectors in the areas of public health and international development. SSS has offices in Silver Spring, Maryland; Durham, North Carolina; Jakarta, Indonesia; Kigali, Rwanda; and Kampala, Uganda. For more information about Social & Scientific Systems Cardiac Core Lab Services, please contact Stephanie Nealis at snealis@s-3.com.
For More Information Contact
Stephanie Nealis
301-628-3000
SNealis@s-3.com
Contact
Social & Scientific Systems, Inc.
Stephanie Nealis
301 628 3000
www.s-3.com
Stephanie Nealis
301 628 3000
www.s-3.com
Contact
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