Ex-Sonora employees start new ultrasound testing company

July 21, 2011
by Brendon Nafziger, DOTmed News Associate Editor
Former employees linked with Sonora Medical Systems' ultrasound testing group have branched out on their own.

Acertara Acoustic Laboratories, an ultrasound measurement and testing lab, said Monday it moved from its former home at Sonora Medical Systems to its own 4,500-square-foot facility in the same town, Longmont, Colo., about 15 miles northeast of Boulder.

The eight-person R&D team, led by G. Wayne Moore, a thirty-year industry veteran and a Sonora founder, will design medical imaging quality assurance devices, and help manufacturers by running tests on new ultrasound equipment, as part of the Food and Drug Administration's 510(k) device clearance process.

Moore said the team, which was the Advanced Development Group within Unisyn Medical Technologies Inc., which owns Sonora, left because the two companies now have a difference in business focus.

In 2009, Sonora was bought by private-equity-funded Medical Imaging Holdings Inc., which also acquired Barrington Medical Imaging and Echoserve, and rolled up the companies into one brand, Unisyn Medical Technologies. But Moore said Unisyn concentrates more on field service and probe repair, while he wanted to work on acoustic power testing and developing new medical imaging quality assurance equipment.

"This business was kind of an outlier for Unisyn," he told DOTmed News. "So we said, 'Well, you know what, this thing really needs to be its own separate entity.'"

In June the new company bought back the intellectual property and technical assets for acoustic testing from Unisyn, Moore said.

Turnkey testing

As part of the company's launch, it's planning a few new offerings. For one, the company says it's developing new medical imaging quality assurance equipment, which it hopes to unveil at the Association for the Advancement of Medical Instrumentation meeting next year.

The other big new offering from the company will be "turnkey" services for 510(k) applications. Previously, the team had helped OEMs by running tests on new ultrasound technology to show the equipment's acoustic power output falls below FDA-set limits. Over the past two decades, the team said it has helped with more than 750 successful ultrasound 510(k) submissions.

But now, because of its experience handling the FDA applications, the company said it'll offer to undertake the whole 510(k) process for clients, including demonstrating that the proposed new devices resemble ones already on the market -- a key requirement of the 510(k) application.

"A lot of our international customers who don't have a presence yet in the U.S. look [to us] to do the entire 510(k) for them," Moore said. "They have asked us a number of times over the years."

Second spinoff

This is at least the second Sonora "spinoff" in the past year. Last September, Bruce Smith left Sonora, where he served as vice president of multi-vendor service business, to start his new company, Medical Systems Technologies. It's also based in Longmont, a town Moore says holds a special appeal to those who've been there.

"It's a wonderful place," he said.