PTS Diagnostics Announces New FDA 510(k) Clearance for PreVantage™ Kitted Solutions
Full PreVantage program availability anticipated by February 2019
INDIANAPOLIS (Jan. 23, 2019) – PTS Diagnostics, a U.S.-based manufacturer of point-of-care testing devices announced today that the U.S. Food and Drug Administration (FDA) has cleared a medical device convenience kit that quantitatively measures the percent of glycated hemoglobin, total cholesterol, high-density lipoprotein, triglycerides, and glucose in whole blood.
“Our solutions can be customized to fit a plethora of different medical and healthcare markets with the overall goal of improving patient and provider satisfaction, increasing efficiency, lowering costs, and maximizing reimbursements,” said Robert Huffstodt, President and CEO of PTS Diagnostics. “This service offering comes as a result of extensive market research in regard to merit-based incentivization.”
In addition to the products contained within the kits, PTS Diagnostics is also offering access to PreVantage ConnectedCare™ and PreVantage ConnectedQC™, the result of recent partnerships with Rimidi and eTrueNorth.
“This consolidation move strategically paired with top-of-the-line, technology-based partnerships marks our transition from a product-based organization to a solutions provider,” said Stephen Riendeau, Chief Commercial Officer at PTS Diagnostics. “We’re excited to keep building upon this early success and growing the PreVantage brand in order to support upcoming value-based care initiatives.”
About PTS Diagnostics
Through its People, Technology and Service, PTS Diagnostics creates health innovation that drives action and results. Since 1992, we have helped medical professionals and patients achieve better health outcomes through our accurate, precise, fast, affordable, and certified point-of-care medical devices. Healthcare professionals have used our CardioChek® products to assess cardiovascular disease risks for more than 140 million patients worldwide through lipid panel screening. And, our A1CNow® systems, which provide fast and reliable HbA1c testing, have helped physicians deliver more effective treatments to patients with diabetes. From our headquarters in the United States of America, we design, manufacture, and market our products to more than 130 countries around the globe. For more information, visit ptsdiagnostics.com.
PreVantage™ is a network of products, strategies, and partnerships aimed at helping healthcare organizations meet rapidly changing industry and consumer demands. By connecting innovations in technology, healthcare delivery, and payment models, PreVantage helps healthcare providers improve efficiency, lower costs, and increase reimbursements while delivering better health outcomes. More information is available at ptsdiagnostics.com/PreVantage.