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The International Medical Device Regulators Forum (IMDRF) has approved a draft document outlining standards for international recognition of groups auditing devicemakers, an FDA official who attended the group’s recent meeting in Sydney, Australia, said.
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New South Korean requirements for medical devices introduced this year make the country’s already strict regulation of foreign devicemakers even more rigorous, an expert says.
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Devicemaker Stryker said it had reached a deal to buy privately held Surpass Medical for $100 million in cash, plus up to $35 million in milestone payments.
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Medtronic announced that it has agreed to buy a 26.4 percent stake in Shenzhen, China-based cardiovascular device maker LifeTech Scientific Corporation.
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Stryker Corporation announced today that it has launched a revolutionary computer-assisted surgery system, Stryker ADAPT, for the Gamma3 Locking Nail system.
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