By a News Reporter-Staff News Editor at Biotech Week Ikaria, Inc., a critical care company focused on developing and commercializing innovative therapies for critically ill patients, announced that the Center for Devices and Radiological Health (CDRH) branch of the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for a software upgrade to enable connectivity of the INOMAX( )DSIR drug delivery system with hospital health information systems (see also Ikaria, Inc.).
This connectivity allows data regarding INOMAX( )usage to be transmitted directly to electronic medical records where it can easily be viewed at computer stations to reduce charting time, avoid transcription errors, and improve billing efficiency. This feature, which is aligned with the effort by major health systems to automate and capture patient data, also facilitates reimbursement for INOMAX usage.
Additionally, the FDA has cleared three new, non-invasive respiratory care devices for use with the INOMAX() DS and DSIR drug-delivery systems the Fisher & Paykel Healthcare Infant Circuit Nasal Cannula and Optiflow? Breathing Circuit and the A-Plus Medical Babi Plus? Bubble CPAP. Sixty ventilators, anesthesia systems and other respiratory care devices have now been validated for use with Ikaria's INOMAX DS and DSIR drug-delivery systems. This represents almost all FDA-cleared ventilation strategies used in neonatal intensive care units (NICUs) throughout the United States.
The INOMAX DS and INOMAX DSIR are proprietary drug-delivery systems that deliver INOMAX() (nitric oxide) for inhalation, the only drug approved by the FDA to treat hypoxic respiratory failure (HRF) associated with pulmonary hypertension in term and near-term infants greater than 34 weeks gestational age. HRF is a serious condition in which blood vessels in the lungs constrict, making it difficult to oxygenate blood. INOMAX selectively relaxes pulmonary blood vessels, improves oxygenation and treats HRF in this fragile newborn population.
These FDA clearances represent Ikaria's ongoing commitment to meet the needs of its customers by offering features that assist them in patient care, data reporting, and billing and reimbursement, and to provide clinicians with the flexibility to safely deliver INOMAX to critically ill patients using almost any FDA-cleared ventilation strategy.
The INOMAX DS and INOMAX DSIR drug-delivery systems are part of a comprehensive offering that, in addition to use of Ikaria's proprietary, FDA-cleared drug-delivery systems, includes INOMAX (nitric oxide) for inhalation, distribution, emergency delivery, technical and clinical assistance, quality maintenance, on-site hospital training, 24/7/365 customer service, and all related disposable items.
A complete list of ventilators, anesthesia systems and other respiratory care devices with which INOMAX drug-delivery systems are validated, as well as additional information about INOMAX, can be found at www.inomax.com.
Keywords for this news article include: Hospital, Chemicals, Chemistry, Ikaria Inc., Nitric Oxide, Respiratory Care, Government Agencies, Offices and Entities, Drug Delivery Systems, Information Technology, Information and Data Systems.
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source: http://www.pharmacychoice.com/news/article.cfm?Article_ID=970983
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