Sparta Systems to Offer Strategies for Electronic Regulatory Reporting at 2nd Annual Innovations in Medical Devices Conference

Holmdel, NJ Feb 25, 2011 – Sparta Systems, Inc., the maker of TrackWise® quality management software and the market leader in enterprise quality and compliance management solutions, today announced that it will present at the 2nd Annual Innovations in Medical Devices conference in a session titled “Regulatory Reporting for Medical Device Companies” on Friday, Feb. 25, 2011, from 11:15 a.m.-12:15 p.m. The event, taking place in Berlin, Germany, will present attendees with proven strategies for implementing an electronic reporting platform.
As global regulations for the reporting of adverse events and incidents in medical device manufacturing become increasingly stringent, more organizations have recognized the benefits of transitioning to electronic systems to track and manage the necessary data for reporting of these incidents. While transitioning to an electronic system for device reporting provides numerous benefits, such as increased efficiencies and improved accuracy of reports, the process can appear to be a daunting and complex challenge for companies seeking to make the switch. This panel discussion will offer attendees best practices for selecting and implementing an electronic medical device reporting solution. The panel, made up of esteemed industry experts, will share experiences and advice for deploying such a solution and gives attendees a roadmap for implementing their own electronic reporting system.
WHO: Moderator:
Joe Goodman, Manager, Solutions Consulting, Sparta Systems
Participants:
Matthias Buerger, Vice President, Quality Assurance and Regulatory Affairs, EMEA, Zimmer
Ursula Morjaria, Director, Clinical Affairs, GE Healthcare
WHEN: Friday, Feb. 25, 2011, 11:15 a.m.-12:15 p.m.
“Regulatory Reporting for Medical Device Companies”
WHERE: Steigenberger Hotel Berlin
Los-Angeles-Platz 1
10789 Berlin, Germany

Precyse Solutions Demonstrates Breakthrough Automated Clinical Documentation and Natural Language Processing-­enabled (NLP) Solution at HIMSS 2011 Conference

Wayne, PA Feb 21, 2011 — Precyse Solutions, a leader in health information management (HIM) services and technologies, will showcase PrecyseCode™, the most advanced health information management platform available today, at the Healthcare Information Management Systems Society (HIMSS) Annual Conference & Exhibition February 20 – 24, 2011, in Orlando, Fla. (Booth #1637). The PrecyseCode software platform features a natural language processing-enabled (NLP) coding engine driven by state‐of‐the­‐art technology that processes and understands human voice, converting it to text and transforming it to information. The NLP coding software is provided by M*Modal, a pioneer of advanced speech understanding technologies, natural language
processing (NLP), and on­‐demand conversational documentation solutions for healthcare professionals. The PrecyseCode kiosk will be part of the M*Modal booth at the HIMSS conference.
“PrecyseCode allows providers to break through the barriers of antiquated processes that up until now have hampered efficiency and productivity,” said President and General Manager, Ken Lacy, Precyse Advanced Technologies. “PrecyseCode represents a big step in our customers’ efforts toward redesigning revenue cycle workflow, enhancing coding efficiency, and enabling fast and efficient responsiveness to physician queries. This single solution provides a snapshot of all necessary management, resource, and reporting tools for mission-­critical health information management processes on one platform, easily monitored and managed through an easy-to­‐follow dashboard.”
Precyse Solutions and M*Modal recently partnered with Geisinger Health System to put Precyse Code’s ICD-­10-­ ready automated clinical documentation and NLP coding software to work to bridge electronic health record (EHR), dictation, transcription, coding and clinical documentation improvement (CDI) processes by capturing physician dictation, editing it, coding it and directing it into an EHR software platform. Based in Danville, Pa., Geisinger Health System is widely recognized for its implementation of innovative care models. Using the Precyse software platform, Geisinger physicians will be able to dictate directly into the EHR with minimal impact to their current workflow patterns. Clinical information will be electronically tagged to be easily searched, mined and analyzed by healthcare team members responsible for driving hospital care and outcomes. The partners aim to see this collaborative technology replicated across the country.
“At Geisinger, we are confident that PrecyseCode will help us to optimize the coding process, improve workflow and accelerate ICD‐10 transition,” noted Joan Topper, Vice President, IT Optimization, Geisinger Health System.

M2S receives Granite State Technology Innovation Grant for improving 3D imaging technology

West Lebanon, NH Feb 17, 2011 – M2S, Inc., a medical image and clinical data management company, announced today that the company has been awarded a Granite State Technology Innovation Grant from the New Hampshire Innovation Research Center. Through this grant, M2S will increase the quality and efficiency of its proprietary 3D imaging technology process. The grant will enhance the technology’s ability to differentiate thrombus, bloodflow and calcification within a 3D model, a quality feature patented by M2S.
The award of this grant supports M2S’s commitment to the development of innovative technologies in the assessment of aortic disease. As the leader in vascular surgery pre-operative treatment planning, long-term patient surveillance, and outcome analysis, M2S is committed to partnering with the strongest minds in order to improve patient care. Through this grant M2S will have the honor to work in collaboration with Dr. Alex Hartov, Professor at the Thayer School of Engineering at Dartmouth College, to develop a fully-automated solution for producing 3D models from CT data in order to deliver highly accurate, standardized anatomical analyses. The accuracy of the 3D model and measurements provided by M2S through its Preview® treatment planning service is crucial for optimal treatment planning and outcomes.
Benefits to the end-users from this project’s enhancements include a more cost-effective vascular procedure planning and patient management system. M2S is at a pivotal point in developing a unified system that will allow physicians to plan treatment, monitor outcomes and identify best practices. At the end of the day M2S is committed to providing quality systems that will improve patient care and reduce health care costs.
The project is set to begin in February 2011. It will utilize M2S’s large database of patient data and Dartmouth’s researchers’ extensive experience in anatomic segmentation and image guided surgery.

Sparta Systems Partners with Synertec Asia to Expand Presence in Southeast Asia

Holmdel, NJ Feb 16, 2011 – Sparta Systems, Inc., the maker of TrackWise® quality management software and the market leader in enterprise quality and compliance management solutions, today announced that it entered into a partnership with Synertec Asia, a multi-disciplined consulting practice providing specialist engineering and compliance services primarily to life sciences customers in Southeast Asia. Synertec Asia will provide Sparta Systems with an established, regional presence for the rapidly growing life sciences markets in Southeast Asia from offices in Singapore and Malaysia.
As a select Channel Partner in the Asia-Pacific (APAC) region, Synertec will provide full support of all TrackWise applications, benefiting existing TrackWise users with greater access to technical support from locally based experts. Life Sciences organizations looking to establish new or upgrade existing quality management systems will benefit from the ease of communication, implementation and ongoing support from a reputable, local agent.
“Our partnership with Sparta Systems further demonstrates Synertec’s long-term commitment to meeting the needs of our customers by establishing local technical expertise for deployment and support of TrackWise products,” said Nick Kotlarski, General Manager, Synertec Asia. “We are excited about the opportunity to provide Sparta Systems’ leading global quality management platform to better assure safe products from our regional manufacturers.”
“As the life sciences sector has matured in Southeast Asia, Sparta Systems has sought ways to bring greater value to its customers and greater TrackWise product availability to prospects,” said Critz Chan, Managing Director, Sparta Systems Asia. “Synertec has provided specialist life science engineering support for more than 15 years and is a recognized leader in best-in-class information management systems and key value-added services. Partnering with Synertec will help extend the power of TrackWise software throughout Southeast Asia and beyond.”
About Synertec
Synertec Asia Pte Ltd is a specialist consultancy practice focused on Southeast Asia with offices in Singapore and Kuala Lumpur. Along with Synertec in Australia, the company operates extensively within the Life Sciences sector, providing a range of engineering, validation and GMP-compliance services to companies engaged in the manufacture of therapeutic products and medical devices. Synertec was incorporated in 1996 and currently employs over 90 professionals in Singapore, Malaysia and Australia. Read more about Synertec Asia on the corporate website www.synertecasia.com
About Sparta Systems
Sparta Systems, Inc. is the industry leader for global quality and compliance management systems. Its TrackWise product is a web-based software application used by quality, manufacturing, and regulatory affairs professionals to manage quality and compliance issues across the enterprise. The company has more than 14 years of experience and an extensive customer base in the life sciences and other highly regulated industries. Sparta Systems offers its customers a complete solution for global quality management needs, including the onsite support required throughout the project lifecycle. More information about Sparta Systems and TrackWise® can be found at www.spartasystems.com.

U.S. HealthWorks Acquires Three Kettering Workers’ Care Medical Centers

Dayton, OH Feb 7, 2011 – U.S. HealthWorks, a leading operator of occupational healthcare centers nationwide, today announced the acquisition of three Kettering Workers’ Care medical centers in Ohio. The acquisition of these three centers doubles the number of U.S. HealthWorks operated medical centers in Ohio and increases the number of centers to 139 nationwide.
The newly acquired Dayton-area medical centers are in Moraine, Huber Heights and Franklin. All three facilities offer occupational medicine services including diagnosis and treatment for injury and illness, preventive services, pre-employment and post-offer exams and screening, and return-to-work rehabilitative care. Terms of the transaction, effective February 7, 2011, were not disclosed.
“U.S. HealthWorks has a highly-regarded national network of physicians, health clinics and medical resources, which is why we’re excited to become a part of their team,” said Dr. Ronald Klein, owner of Kettering Workers’ Care.
“As leaders in the Dayton area for many years, the Kettering Workers’ Care centers represent key additions to the U.S. HealthWorks family,” said Greg Marotta, vice president of operations. “And as we continue to expand our business in Ohio, these three quality healthcare facilities will make invaluable contributions to our success.”
U.S. HealthWorks also operates two health clinics in Columbus and one in Canton.

U.S. HealthWorks Acquires Southern Florida’s MedWork 84, Medstar Medical Centers

Ft. Lauderdale, FL Feb 1, 2011 – U.S. HealthWorks, the leading operator of occupational healthcare centers in Florida, today announced the acquisition of two medical centers in South Florida – Medwork 84 in Ft. Lauderdale and Medstar in Pompano Beach. The acquisition of these two centers expands the number of U.S. HealthWorks operated medical centers in Florida to 14 and to 136 nationwide.
The medical centers are located at 407 SE 24th Street in Fort Lauderdale and 3501 North Federal Hwy in Pompano Beach. Both facilities offer occupational medicine services including, diagnosis and treatment for injury and illness, preventive services, pre-employment and post-offer exams and screening, and return-to-work rehabilitative care. Terms of the transaction, which was effective February 1, 2011, were not disclosed.
“As a provider of occupational medicine in Florida for many years, we recognize the innovation and resources U.S. HealthWorks will bring to our current patients and clients,” said Dr. Seth Feldman, who will serve medical director for both clinics. “U.S. HealthWorks national network of physicians and health clinics is a great match for us.”
“U.S. HealthWorks is the leading practice management company for occupational medicine in Florida and we’re pleased that two top quality facilities like Medwork 84 and Medstar have joined our team. Dr. Feldman’s experience and reputation in South Florida will be invaluable to our continued success in the region.” said Greg Marotta, vice president of operations.

Paragon Medical Names New Chief Compliance Officer

Pierceton, IN Feb 1, 2011 – Pierceton based Paragon Medical announces the addition of Michael Gosmeyer as Chief Compliance Office (CCO) and Vice President of Quality and Regulatory Affairs.
Mr. Gosmeyer joins Paragon after having served as the Director of Regulatory Affairs at the headquarters of Hill-Rom, a global medical device company. He has spent the past few years managing and overseeing company wide Regulatory and Quality Systems, as well as, all FDA interface points. Previous positions with Hill-Rom include Director of Quality Assurance where he was responsible for manufacturing operations in Europe, Mexico and the United States.
In addition to his quality management experience, Mr. Gosmeyer also has a strong engineering background and has held various engineering management positions overseeing product engineering, design assurance, product life-cycle management, and continuous improvement. He is Six Sigma Greenbelt Certified and holds an MBA, as well as a BS in Electrical Engineering from Purdue University.
In his new role, Mr. Gosmeyer’s span of Quality and Regulatory responsibilities will give him oversight of Paragon’s current Global Quality Organization. “This position demonstrates our ongoing commitment to the medical device industry’s complex Quality and Regulatory compliance requirements and our conviction to ensure that our products and services meet and ultimately exceed our customers’ desires and expectations,” commented Tobias Buck, Founder, Chairman, President and CEO for Paragon. “Our objective is to be in an industry leading position, elevating our internal expectations as well as complying with those of our clients. Mike brings an outstanding level of experience, skills and perspective to Paragon Medical that will only enhance the products we manufacture on our clients behalf and the service portfolio we extend into the marketplace,” Buck added.

Paragon Medical Celebrates 20 Years of Innovation

Pierceton, IN Feb 1, 2011
For Paragon Medical, Inc., and one of its founders Tobias Buck, June 17th was a day for celebrating. Coincidentally with it being Mr. Buck’s birthday, Paragon Medical celebrated their 20 year anniversary since being founded. The company traces its roots back to 1991 when it began as a polymer molding company and a systems integrator, as well as a medical device tier one supplier.
Twenty years, and countless innovations later, Paragon Medical is recognized as an industry leading turnkey supplier of world-class solutions for instrument delivery systems, surgical instrumentation, implantable components and design services to the medical device marketplace, worldwide. The company has grown from a start-up business with only a handful of employees to a global company approaching 1,000 employees in three countries.
The company celebrated this significant milestone by holding luncheons at all of its divisions worldwide, recognizing the efforts of those who have contributed to the success of Paragon over the years. Employees, state and local dignitaries, suppliers, and other VIP’s were on-site at Paragon’s corporate headquarters in Pierceton, Indiana to commemorate the occasion and honor the employees whose exceptional performance made the day possible.
Mr. Buck addressed the employees and talked about what has sustained Paragon for the past 20 years and how the company must transform itself to address the future. He told them, “I am extremely proud of the people who make up the Paragon family. I have always believed that our employees are some of the best in the industry and are truly our most important asset. They are the foundation of everything that makes Paragon the great company it is today. The global team has stood together to attain the goals that we set regardless of the operating context.”
The company has a culture of quality and relationship development that emphasizes sensitivity to their client community through service, and innovation. In the current era of healthcare reformation there has recently been an increased focus on how the products they manufacture impact the patients and the personal responsibility that each employee has. “At the very heart of our culture is our continuous focus on achieving results, along with constant attention to customer and patient satisfaction,” Buck continued. “We believe that we are uniquely positioned with our depth and breadth of technologies and services, our management strength, and superior employee base to be a company built to last and built to lead through the next 20 years, and beyond.” Twenty years later, the vision of the company has remained consistent: to be the preferred manufacturer of products and total instrument management solutions for the surgical marketplace, worldwide. Doing so in such a customer sensitive fashion that we either meet or exceed our client’s expectations on every application.