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Indian regulators are establishing quality manufacturing standards for medical devices and diagnostics to align the country’s requirements with international standards and move away from its system of regulating the products under rules designed for drugmakers. Read More
Stryker and its OtisMed subsidiary must ante up more than $80 million for distributing knee replacement surgery cutting guides that had been denied FDA clearance. Parent Stryker will also establish a compliance program to ensure all marketed products have the necessary approvals. Read More
The Indian government appears poised to expand foreign direct investment by medtech companies as it searches for ways to beef up domestic manufacturing. Read More
Medical imaging maker Volcano was plucked up by Royal Philips for $1.2 billion, just days after Wall Street analysts predicted a rocky year ahead for the San Diego, Calif., devicemaker. Read More
Yet another court has ruled against Myriad Genetics in ongoing disputes over the company’s patents on tests to detect genes associated with breast cancer. Read More
A Government Accounting Office review of Medicare’s competitive bidding program shows that payment amounts for a sample of 28 Healthcare Common Procedure Coding System codes generally decreased during all bidding rounds, compared with the average fee-for-service payment for the same codes in 2010. Read More
Stryker and its OtisMed subsidiary must ante up more than $80 million for distributing knee replacement surgery cutting guides that had been denied FDA clearance. Parent Stryker will also establish a compliance program to ensure all marketed products have the necessary approvals. Read More