by
Keith Loria, Reporter | February 19, 2011
From the January/February 2011 issue of HealthCare Business News magazine
“There’s a lot of talk about dose reduction,” says Greg Cefalo, U.S. business imaging manager for Agfa HealthCare. “We take it seriously. You don’t want to take the dose down and lose clinical information. You want to be sure you are getting the information a physician needs to make the diagnoses.”
According to Aaron Ybarra, X-ray product manager for Toshiba America Medical Systems, customers have been asking more about dose in the past few months.
“What’s coming down the road is DICOM dose structured reporting, as a lot of customers are concerned with this and radiation,” he says. “We started working on DICOM reporting last year and we are hopefully going to see that become part of our product in June of this year.”
“Dose is the big newsworthy topic that is out there and it will be newsworthy for a while,” says Kris Kessler, creative marketing manager for Canon. “As there is a greater emphasis, you will see more solutions.”
Canon implemented dose decreases on its new wireless detector, the Canon CXDI-70C Wireless Digital Radiology System, yet also increased the resolution by 50 percent.
FDA action
The U.S. Food and Drug Administration’s recent reclassification of some digital mammography devices to Class II reduces the barrier of entry for some companies that have mammography plans in place. It also reduces an obstacle for brand-new entrants, but the technical requirements are still significant.
“The initial impact is several new products have been approved by the FDA and we’re expecting it to be a much easier process in the long run,” Fujifilm’s Fabrizio says. “Mammo was classified as Class III, requiring pre-market clinical trials. Now it’s downgraded to what is basically the same as all of our X-ray products. It will bring more competition and be a benefit for the customers as it will result in better products and faster release of new products.”
This will enable Fujifilm to release its Aspire HD DR product two years ahead of time.
Carestream, which had already been selling its mammography units all over the world, is excited about making its products available to its U.S. customers soon. “Now that we have approval from the FDA, which we actually received under the strict guidelines before they loosened the rules, we will be selling more of our CR systems into the mammography settings,” Heizyk says.
For Agfa, the new classification will help the company’s release of its latest offering for the U.S. breast imaging market — the IMPAX, which offers relevant prior exams automatically pre-fetched from the archive management system and sent to the diagnostic review station.
