BRAINTREE, Mass., March 28, 2018 /PRNewswire/ -- Haemonetics Corporation (NYSE: HAE) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for enhancement of its NexSys PCS™ embedded software. This capability activates the YES™ technology, a yield enhancing solution enabling increases in plasma yield per collection.
This 510(k) cleared by FDA includes the following information on the label: "On average, YES technology will yield an additional 18-26 mL more plasma per donation."
David Wilson, President, Global Plasma, stated: "This regulatory clearance allows us to advance as planned toward the commercial launch of NexSys PCS this summer. We are now able to deliver our entire offering – the NexSys PCS device, its embedded software including YES technology, the NexLynk DMS™ donor management software, disposables, technical support and service – to customers in the U.S."
The Company also announced CE-mark clearance of the NexSys PCS device in the European Union and Australia, subject to additional local requirements. The NexSys PCS device received U.S. FDA 510(k) clearance in July 2017.
Chris Simon, President and CEO, added: "This is an important milestone for Haemonetics and the customers we serve. NexSys PCS is a step-change improvement in plasma collection and will serve as a platform for us to advance meaningful innovation in every aspect of our offering."
Haemonetics (NYSE: HAE) is a global healthcare company dedicated to providing a suite of innovative hematology products and solutions for our customers, to help them improve patient care and reduce the cost of healthcare. Our technology addresses important medical markets: blood and plasma component collection, the surgical suite, and hospital transfusion services. To learn more about Haemonetics, visit our web site at http://www.haemonetics.com.
NexSys PCS, NexLynk DMS and YES are trademarks or registered trademarks of Haemonetics Corporation in the USA, other countries, or both.
FORWARD LOOKING STATEMENTS
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Forward-looking statements in this press release may include, without limitation, statements regarding plans and objectives of management for operations of the Company, including plans for commercialization of the Company's NexSys PSC plasma collection system and NexLynk DMS donor management system.
Such forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon the Company's current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties.
Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, technological advances in the medical field and standards for transfusion medicine and our ability to successfully offer products that incorporate such advances and standards, product quality, market acceptance, regulatory uncertainties, including in the receipt or timing of regulatory clearances, the effect of economic and political conditions, the impact of competitive products and pricing, blood product reimbursement policies and practices, and the effect of industry consolidation as seen in the plasma market.
Additional risk factors are identified and described in more detail in the Company's filings with the SEC.
The Company does not undertake to update these forward-looking statements.
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SOURCE Haemonetics Corporation