Technology | Information Technology | July 10, 2015

Lexmark Healthcare Receives FDA Clearance for NilRead Enterprise Viewer

Clearance includes the entire NilRead product family and covers a wide variety of medical imaging studies, including mammography and digital breast tomosynthesis

Lexmark, NilRead Enterprise Viewer, FDA clearance, zero-footprint viewer

July 10, 2015 - Lexmark  announced that it has received 510(k) Class II clearance from the U.S. Food and Drug Administration (FDA) for Lexmark NilRead, a Web-based, zero-footprint enterprise diagnostic viewer. The NilRead viewer is available in multiple configurations – core, clinical and interpretation – covering different workflows, ranging from the distribution of imaging studies and reports within the enterprise to full primary interpretation workflows in decoupled enterprise image management implementations.

Lexmark acquired Toronto-based Claron Technology Inc., including its NilRead line of medical image viewing, distribution, sharing and collaboration products, in January 2015. NilRead is part of Lexmark's Healthcare Content Management (HCM) suite of solutions designed to enhance a clinician's ability to make informed decisions by providing a comprehensive view of all relevant patient information in context of the patient. Lexmark HCM provides greater interoperability of patient content as healthcare delivery organizations move to an enterprise approach to managing medical images and other healthcare content that typically exists outside the electronic medical record (EMR) and other core applications.

The 510(k) Class II clearance by the FDA means healthcare organizations in the U.S. are now able to use Lexmark NilRead to perform diagnostic review and interpretation of a wide variety of medical imaging studies, including mammography and digital breast tomosynthesis (DBT) studies. The zero-footprint design of NilRead enables these large files to be delivered throughout a healthcare enterprise to local clinician workstations without download wait times. This is significant in a mammography screening environment where the daily volume of imaging studies reviewed is high.

Each Lexmark NilRead configuration provides physicians with secure, interactive processing, viewing, and sharing of 2-D, MPR, 3-D, and fusion radiology exams. It provides interactive image processing and visualization tools and rule-based exam viewing to support physician preference and multi-monitor display configuration. NilRead can be easily integrated with any DICOM or HL7 network, connected with a vendor neutral archive (VNA) and invoked from a radiology information system (RIS) or workflow/reporting solution. NilRead can also query-retrieve remote DICOM and Web DICOM nodes, XDS repositories and other medical archives.

As healthcare organizations move to an enterprise approach for managing medical images and other healthcare content, Lexmark NilRead functions as the enterprise viewing solution that gives clinicians universal access to all patient imaging through the EMR, electronic health record (EHR) or health information exchange (HIE). NilRead also supports dedicated interpretation workflows for radiology and other specific departments. With NilRead, referring physicians and diagnosticians are able to work together more effectively to treat patients without the constraints of service line silos. Clinicians are able to quickly and efficiently access and interact with images and reports for all patient images in a single view across the enterprise.

For more information: www.lexmark.com

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