The following summary is on todays FDA Device Daily Bulletin:
New Radiation Dose Requirements Would Increase Cost of Devices
Incorporating too many new safeguards into imaging equipment to prevent excessive doses of radiation could make the devices too expensive for the market, manufacturers told CDRH at a workshop last week. Before moving forward with new requirements, CDRH should consider the cost of adding features to imaging equipment, Charles Shaughnessy, manager of the physics, detectors and imaging group at Analogic, said. Otherwise, the cost could limit the availability of CT scans and their expansion into new markets, he added.
If true, this will help Dominion sales.
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