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The FDA warned automatic external defibrillator (AED) maker MRL for several current good manufacturing practice (cGMP) violations and said the company's devices are adulterated and misbranded.
After a visit to Chinese device firm Mindray's R&D and manufacturing sites, "our observations and dialogue with management have increased our confidence that the company is likely to achieve our above-consensus sales and earnings forecasts in the next few years," Merrill Lynch Research analyst Bin Li said in a Jan. 24 research note.
Medtronic's Physio-Control business reportedly may be reducing the work force at its Redmond, Wash., facility in the wake of the firm's manufacturing suspension of Lifepak defibrillators.
After the FDA warned Tiara Medical Systems for several current good manufacturing practice violations regarding its complaint handling system, the company successfully responded to all charges, the agency said.
The FDA and the Centers for Medicare & Medicaid Services (CMS) need to base their product approvals and reimbursement decisions on more complete evidence when dealing with costly new technologies such as heart imaging devices, an expert says.
FDA Commissioner Andrew von Eschenbach hsd announced the creation of the Office of the Chief Medical Officer. The office will be overseen by Janet Woodcock, who served most recently as the FDA's deputy commissioner for operations.
The "art and science" of branding -- developing name and image recognition for a particular product and company -- is still in the developmental stages in the device industry, according to Nancy Turett, president of the health division at Edelman, a public relations and strategic communications consulting firm.