A Medical Device Daily

Staar Surgical (Monrovia, California), a manufacturer of minimally invasive ophthalmic products, said it has received approval from the State Food and Drug Administration (SFDA) in China to market the Visian ICL (implantable collamer lens) to ophthalmologists and other eye care professionals in that country.

Made of Staar's highly biocompatible Collamer material, the ICL is the only minimally invasive foldable lens of its kind approved for the Chinese commercial market.

As a result of what the company described as the product's “unique foldable design,” it said the ICL procedure allows an incision up to 50% smaller than competing technology, and its placement in the eye behind the iris provides “a more aesthetically pleasing outcome.”

“This approval is an important achievement for Staar,” said David Bailey, president and CEO. “It will allow us to enter a market that we believe has the potential to become one of the largest markets for the Visian ICL. Currently, China is the second-largest market in the world for the LASIK procedure and there is a higher rate of incidence for myopia and astigmatism in Asian countries compared with the rest of the world. With these two market dynamics, we believe that successful entry into this market could lead to meaningful growth in our overall refractive business.”

Bailey said his company already has established a training center and a regional distribution operation in China. “A proctor has been hired and we expect to begin procedures [this month],” he said. “We also continue to pursue approval from the SFDA for the Visian Toric ICL and are hopeful that we will receive approval by the end of the current year.”

Professor Shen Ye of the Zheyi Eye Center (Hangzhou, China) said, “The Visian ICL provides a very safe choice for correcting myopia. The ICL allows the patients the opportunity to acquire excellent natural vision. Our clinic research indicates that the ICL has very high patient satisfaction levels.”

In May 2005, Staar reported that it had received approval to market the Visian Toric ICL in South Korea and the ICL and Toric ICL in Singapore. South Korea is currently the company's largest Asian market for the Visian ICL and TICL and one of the top two markets internationally.

Staar's ICL is approved for sale in 43 countries. More than 50,000 have been sold worldwide.

Mexican distributor for Guardian solutions

Guardian Technologies International (Herndon, Vir- ginia), a provider of high-performance security and healthcare solutions based on Intelligent Imaging Informatics (3i), said it has entered into a distributor agreement with Electronica y Medicina (EYMSA; Mexico City) to market, sell and support Guardian's healthcare solutions for radiology within the Mexican healthcare community.

Guardian's FlowPoint system, built on an expandable set of configurable web services architecture, provides intrinsic, seamless radiology information system (RIS), image management, radiology workflow and archive management solutions. It features open systems architecture principles.

Richard Borrelli, vice president for business development at Guardian Healthcare, said, “Based on our market research, there are approximately 3,350 hospitals and imaging centers in the Mexican market. The market potential for RIS/PACS technologies is extremely significant given that few hospitals currently have this technology installed.”

He added: “Our partnership with such a prestigious organization as EYMSA, along with their extensive healthcare client list and knowledge of healthcare technologies, positions Guardian Technologies and EYMSA to immediately sell our products and services to this emerging Mex-ican marketplace.”

EYMSA maintains branch offices in five locations throughout Mexico. In business for 25 years, the company employs a total staff of approximately 200, including 50 sales representatives and 100 field service engineers dedicated to providing technical support to the installed base of customers.

Guardian said EYMSA's customer base includes more than 95% of the hospitals in Mexico.

Guillermo Monroy Rivera, EYMSA's sales manager, said, “This is an excellent opportunity for both companies to make a breakthrough 'first punch' in a market that is ready to adapt to digital, but wants to use technology solutions designed to meet their specific needs and requirements.”

Diagnostic test kit company starts up

Harbin First Bio-engineering Co. Ltd. (Harbin, China), located in Heilongjiang province, was established on July 21. The company, a wholly owned subsidiary of China Sky One Medical, is a producer of diagnostic test kits.

Its first two products under development are the Requirements for Diagnostic Kit for Micro-albumin and the Early Stage Pregnancy Diagnostic Kit. Both are expected to be entering the market later this year.

Harbin First Bio-Engineering is located in the Heilongjiang Bin Xi Economic Development Zone, located about 19 kilometers from Harbin city via freeway. The total size of the factory is 40,000 square meters and the completed construction area reaches up to 10,000 square meters, which include workshops, office building and R&D center.

The workshop is designed and constructed to conform to Good Manufacturing Practices standards, including the general working area, cleaning areas and two production lines for manufacture of ELISA reagents and colloidal gold reagents, and complementary labs and packing rooms.

NIMS signs Argentine distributor

Non-Invasive Monitoring Systems (NIMS; North Bay Village, Florida) has entered into an agreement with Iraola Y CIA (Buenos Aires, Argentina) to market and sell NIMS's AT-101 Motion Platform and future home version of the AT-101 throughout Argentina.

CEO Gary Macleod said Iraola is “a well-established and recognized medical equipment distributor that has provided a full line of quality products and services for over 40 years in Argentina.”

He said the agreement, latest in a series of international distribution accords signed by the company, “reflects our strategy to license our proprietary products to the global marketplace as we plan our clinical trial for FDA marketing approval in the U.S. for the intended use of providing drug-free, non-invasive, temporary relief of musculoskeletal pain associated with osteoarthritis of the hips.”