Mortara Instrument, Inc. Announces FDA 510(k) Clearance to Market Its Multi-Modality DICOM Review Toolset for Resting ECG, Stress and Holter

September 07, 2016

CardioConfirm, the latest innovation from a leading U.S. medical device manufacturer

MILWAUKEE – Mortara Instrument, Inc. (Mortara), a Milwaukee-based designer, developer and manufacturer of diagnostic cardiology (ECG) and patient monitoring technologies and devices, announced today that the newest release of its multi-modality DICOM® review toolset for resting ECG, cardiac stress exercise and Holter has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

Mortara’s commitment to standards based integration is the guiding principle behind the innovative, multi-modality, DICOM-based solution CardioConfirm. This new offering consists of embeddable software for Electronic Health Records (EHR) and Picture Archiving and Communication Systems (PACS) to add diagnostic cardiology workflow capabilities.   CardioConfirm can readily expand the capabilities within an EHR or PACS offering to incorporate workflow traditionally enabled by standalone ECG Management solutions.  The toolset is built upon over thirty years experience in diagnostic ECG workflow and incorporates Mortara’s VERITAS™ serial comparison algorithm for automatic comparison of serial resting ECGs.  Mortara DICOM devices and VERITAS algorithm solutions are widely used by hospitals, clinics and physician offices in a variety of applications and care settings.  CardioConfirm now helps to embed the outputs of those devices directly into EHRs and PACS solutions to enable ever more highly integrated clinical information solutions.

“The use of the DICOM ECG standard allows the PACS/EHR to receive and present raw ECG data seconds after it has been acquired,” said Joe Austin, Chief Sales Officer of Mortara. “The newly-acquired ECG, stress exercise or Holter study, along with prior encounters, critical test results, interpretations and observations, are all now included within the PACS/EHR. This consolidation of patient health information provides the physician with a more comprehensive view of the patient’s medical history, setting the stage for improved clinical decision-making.”

CardioConfirm is now broadly available for license in both Standard and Enterprise versions.  An easy to integrate, well defined application program interface (API) with full documentation and sample code is available to interested PACS and EHR solution providers.  To explore further how CardioConfirm can optimize your PACS or EHR’s workflow, please contact Aruna Talapatra, Global Marketing Manager, IT Solutions at Mortara:

Mortara Instrument Media Contact:  Sondra Kaufman; sondra.kaufman @



Mortara offers a complete line of non-invasive diagnostic cardiology solutions for your practice or hospital.



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Mortara is the leading provider of ECG algorithms and components for various applications.