December 26, 2013
Physician Software Systems Receives FDA 510(k) Clearance for its PhySoft Anemia Management System™.
PhySoft AMS™ establishes a new technology category – software which simulates the dynamics of erythropoiesis for each individual patient, providing individualized anemia management.
LISLE, IL, December 26, 2013, Physician Software Systems announced today that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its anemia management system – PhySoft AMS™. The software application provides individualized anemia management for dialysis patients by simulating each patient’s ESA-response to help physicians and clinicians determine the optimal ESA dosage to manage hemoglobin cycling and improve patient outcomes.
PhySoft AMS™ was created in cooperation with Mayo Clinic. The Mayo Clinic team wanted to be able to choose target hemoglobin levels that were appropriate and unique to each patient situation. Their goals were to improve care by creating a methodology to systematically maintain more patients at their target Hgb-level, manage hemoglobin variability, and provide their clinicians a patient-condition “dashboard” display of anemia-related factors and trends. Mayo Clinic focused on improving patient care, achieving better and sustainable outcomes, based upon each patient’s unique requirements.
Physician Software Systems has created a software application based upon the Mayo Clinic technology, to more precisely manage the anemia experienced by dialysis patients. The application is called PhySoft AMS™. It enables physicians to choose the appropriate Hgb-target level for each individual patient. PhySoft AMS™ then uses the patient’s historical lab data and ESA dosing history to model that individual’s ESA-response, and recommend the optimum dosing regimen for that patient. Physicians choose the Hgb-target that is right for the patient, and PhySoft AMS™ recommends the precise dosing regimen needed to meet and maintain that goal.
Mayo Clinic focused on improved patient outcomes and quality of life, and as a very positive byproduct were able to exceed the improvements in average Hgb levels and ESA reductions brought about by the guideline and labeling changes of the past few years. They improved care, while reducing costs well beyond guideline driven ESA decreases.
PhySoft AMS™ is now available in the United States and Canada.
About Physician Software Systems
Physician Software Systems is focused on improving patient outcomes through innovative technologies that facilitate the delivery of individualized medicine, reduce costs by eliminating generalized, protocol-based treatment, and transform the way healthcare is delivered. Our products lead the way in cost-effective patient care improvements. We partner with leading medical research institutions around the world to combine new concepts in individualized medicine with our technology expertise, under the guidance of a thought-leading Scientific Advisory Board.
Chief Client Officer
Physician Software Systems