Medison nets FDA clearance for 3-D Voluson 530 scanner

Korean vendor adds staff in U.S. for sales effort

Medison is ramping up its efforts to become a player in the North American ultrasound market following 510(k) clearance of its integrated 3-D ultrasound scanner. Medison's Voluson 530 received Food and Drug Administration clearance in February, ending a long regulatory road for the product.

Medison will be adding 40 to 45 sales, marketing, regulatory, and R&D positions for its Medison America division over the next month, according to new Medison America president and CEO Peter Klein. The company will also be moving its U.S. headquarters to bigger premises in Pleasanton, CA, where the company's U.S. operations are based.

Medison gained access to Voluson 530 through its acquisition of Austrian firm Kretztechnik in April 1996. U.S. clearance for Voluson 530 has been a long time coming, even by FDA standards. Kretztechnik submitted a 510(k) application for the scanner, then known as Combison 530, in 1994, and waited for two years without success. The lack of U.S. sales was cited as one of the possible reasons behind the Austrian firm's sale of a 60% interest in the company to Medison (SCAN 5/22/96).

With the addition of the high-end Voluson 530 scanner to its product line, Medison is now positioned to become a full-scale ultrasound company, Klein told SCAN in an interview at the annual meeting of the American Institute of Ultrasound in Medicine in San Diego last month.

"In the past, Medison was focused on certain market niches and the products had been more in the low-end segments," Klein said. "Now we have a system that matches the image quality of the high-end systems, but also has 3-D features as an integrated part of the machine."

Klein joined Medison America on March 1, replacing Mark Hayward as president. Klein had previously served as founder and president of ultrasound 3-D developer TomTec Imaging Systems of Boulder, CO.

With Voluson 530, images can be acquired in three to five seconds and reconstructed and displayed in 3-D in real time for abdominal images, with 1.5-second acquisition times for transvaginal images, according to the company. Medison believes the system will be of particular use in gynecological and radiological applications.

In addition to 3-D, Voluson 530 also includes features such as color and power Doppler and B-mode imaging, as well as a tissue Doppler mode, according to the company.

Voluson 530 will carry a list price ranging from $170,000 for standard configurations up to $200,000 for a model that includes 3-D capabilities. Medison will also be aggressive in pricing to gain market share, Klein said.

Voluson 530 will probably not be sold through Kretz's former distribution partner, Cone Instruments of Solon, OH, which had rights to all markets in North America for Combison 530. Medison is negotiating an agreement with Cone to sell Medison products to the urology market, but Voluson 530 is probably too expensive for that segment, according to Klein.

Cone last month won rights to another 3-D ultrasound product, the Sirus workstation developed by Life Imaging Systems of London, Ontario, which debuted the product at last year's Radiological Society of North America meeting (SCAN Special Report 12/96). The company has rights to distribute Sirus to all ultrasound markets in the U.S. except cardiology, according to Cone president Jay Cone. Sirus received 510(k) clearance last year, and Cone began selling the system April 1.