Siemens Healthineers Receives FDA Clearance for Blood Urea Nitrogen and Total C02 Point-of-Care Testing
- Blood Urea Nitrogen and Total Carbon Dioxide testing at the point of care improve patient care
with results in less than a minute.
- Renal injury and metabolic diseases are common among critically ill patients who benefit from
immediate results.
Siemens Healthineers announced today it has received 510(k) clearance from the U.S. Food and Drug Administration for its Blood
Urea Nitrogen (BUN) and Total Carbon Dioxide (TCO2) point-of-care tests to aid in the diagnosis of renal diseases and
metabolic imbalances. These assays expand precision medicine performed at the patient-side to enable faster clinical decision
making.
In its continued effort to improve patient care, Siemens Healthineers now can provide a full menu on a single test card within
the blood analysis market for clinicians to perform at the patient bedside on the handheld epoc® Blood Analysis System. A broad
menu benefits clinical service lines that routinely perform blood analysis, including critical care units, the emergency
department, radiology, cardiac catheterization labs and out-patient centers.
“With the epoc system, these new assays will expand the patient information clinicians can access sooner to help rule in or rule
out potential diagnoses more quickly,” said Michael Sampson, Senior Vice President, Point of Care Diagnostics, North America,
Siemens Healthineers. “Rapid, informed diagnoses and treatment decisions at the patient-side ultimately aids in improving clinical
outcomes.”
BUN—combined with creatinine and an estimated glomular filtration rate (eGFR)—also available on the epoc system—can aid in the
differential diagnosis of renal and metabolic diseases. TCO2—with other parameters that comprise a basic metabolic panel
currently available at the point of care from Siemens Healthineers—can aid clinicians in assessing acid base and metabolic
imbalances and make changes in therapy where necessary.
The epoc® Blood Analysis System delivers a full menu of results, including pH, partial pressure of oxygen, partial pressure of
carbon dioxide, sodium, potassium, ionized calcium, hematocrit, glucose, lactate, creatinine, chloride, and soon BUN and
TCO2, in less than a minute. Results are easily integrated into any Laboratory Information System.
Learn more about the epoc Blood Analysis System and BGEM Test Card.
Siemens Healthineers is the separately managed healthcare business of Siemens AG enabling healthcare providers worldwide
to achieve better outcomes at lower costs by empowering them on their journey towards expanding precision medicine, transforming
care delivery, improving patient experience and digitalizing healthcare. A leader in medical technology, Siemens Healthineers is
constantly innovating its portfolio of products and services in its core areas of diagnostic and therapeutic imaging and in
laboratory diagnostics and molecular medicine. Siemens Healthineers is also actively developing its digital health services and
enterprise services. In fiscal 2017, which ended on September 30, 2017, Siemens Healthineers generated revenue of €13.8 billion and
profit of €2.5 billion and has about 48,000 employees worldwide. Further information is available at www.siemens.com/healthineers.
Siemens Healthineers
Kimberly Nissen, +1 610 448-6355
Kimberly.Nissen@siemens-healthineers.com
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