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Wired News – Haemonetics Received 510(k) Clearance from FDA of NexSys PCS(TM) Embedded Software

Stock Monitor: Alphatec Holdings Post Earnings Reporting

LONDON, UK / ACCESSWIRE / April 02, 2018 / Active-Investors.com has just released a free research report on Haemonetics Corp. (NYSE: HAE). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=HAE as the Company's latest news hit the wire. On March 28, 2018, the Company announced that it has received 510(k) clearances from the US 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. Register today and get access to over 1,000 Free Research Reports by joining our site below:

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Active-Investors.com is currently working on the research report for Alphatec Holdings, Inc. (NASDAQ: ATEC), which also belongs to the Healthcare sector as the Company Haemonetics. Do not miss out and become a member today for free to access this upcoming report at:

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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Haemonetics most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:

www.active-investors.com/registration-sg/?symbol=HAE

The Company also announced CE-mark clearance of the NexSys PCS device in the European Union and Australia, subject to additional local requirements.

Clearance Allows Haemonetics to Advance the Planned Commercial Launch of NexSys PCS

David Wilson, President of Global Plasma Haemonetics, stated that this regulatory clearance allows the Company to advance as planned towards the commercial launch of NexSys PCS this summer.

David added that Haemonetics is now able to deliver its 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 United States.

NexSys PCS is a Step-Change Improvement in Plasma Collection

Commenting on the approval, Chris Simon, President and Chief Executive Officer of Haemonetics, added that this is an important milestone for Haemonetics and the customers the Company serves. NexSys PCS is a step-change improvement in plasma collection and will serve as a platform for the Company to advance meaningful innovation in every aspect of its offering.

FDA Cleared NexSys PCS™ in July 2017

On July 28, 2017, Haemonetics received FDA 510(k) clearance for its NexSys PCS™ plasmapheresis system. The NexSys PCS included bi-directional connectivity to Haemonetics' donor management system, NexLynk DMS™, and built on Haemonetics' industry leading position with a design inspired by extensive user research.

About NexSys PCS™

The NexSys PCS plasmapheresis system is designed to improve the key performance indicators that matter to you: Productivity, Quality & Compliance, Yield, and Donor Satisfaction. Open, bi-directional BECS connectivity helps eliminate inefficient, paper-based processes and the need for PDA-based phlebotomy documentation systems. Simple, guided operation is designed to streamline collection processes. Large alert beacon enhances operator responsiveness, helping accelerate donor throughput. Improved serviceability helps maximize device uptime.

FDA 510(k) Clearance

A 510(k) is a premarketing submission made to the FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval (PMA). 510(k) (premarket notification) to FDA is required at least 90 days before marketing unless the device is exempt from 510(k) requirements.

About Haemonetics Corp.

Founded in 1971 and headquartered in Braintree, Massachusetts, Haemonetics is a global healthcare company dedicated to providing a suite of innovative hematology products and solutions for its customers. The Company's comprehensive portfolio of integrated devices, information management, and consulting services offers blood management solutions for each facet of the blood management continuum. NexSys PCS, NexLynk DMS, and YES are trademarks or registered trademarks of Haemonetics in the USA, other countries, or both.

Stock Performance Snapshot

March 29, 2018 - At Thursday's closing bell, Haemonetics' stock was marginally up 0.44%, ending the trading session at $73.16.

Volume traded for the day: 476.33 thousand shares.

Stock performance in the last month – up 3.19%; previous three-month period – up 25.58%; past twelve-month period – up 80.95%; and year-to-date - up 25.96%

After last Thursday's close, Haemonetics' market cap was at $3.89 billion.

The stock is part of the Healthcare sector, categorized under the Medical Instruments & Supplies industry. This sector was up 0.5% at the end of the session.

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