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The FDA has warned Ambco Electronics after the devicemaker failed to correct deficiencies noted during a California Department of Public Health inspection and an earlier FDA inspection. Read More
The FDA’s Circulatory Systems Devices Panel Wednesday recommended approval of Boston Scientific’s Watchman device, giving a nod to the left atrial appendage closure technology for an unprecedented third time. Read More
CDRH staff recruitment and retention continue to suffer from lack of resources, according to FDA Commissioner Margaret Hamburg, who said she is “stunned” that the agency accomplishes as much as it does. Read More
Former Secretary of State Hillary Rodham Clinton said Wednesday that she would consider repealing the controversial 2.3 percent medical device excise tax. Read More
The FDA and Centers for Medicare & Medicaid Services’ parallel review pilot program continues to face hurdles, even while products released through the program have reached the U.S. market, officials of both agencies say. Read More
The FDA is taking a hard look at ways to bring early-stage device trials back to the U.S., hoping to reverse a decade-long trend that has seen companies moving them overseas. Read More
The FDA Tuesday unveiled a broad plan that will change the way it inspects devicemakers, handles recalls, issues and reviews enforcement decisions and screens imports, with companies likely to start feeling the impact by the end of 2015.
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India’s medtech industry could reach $50 billion by 2025 if comprehensive regulatory and reimbursement infrastructures are put in place, a new market research report says. Read More
South Korea’s Ministry of Food and Drug Safety is amending its standards for electromagnetic safety of medical devices to align them with international standards. Read More