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The FDA handed Encompas Unlimited a warning letter for failures in quality control, implementation of medical device reporting procedures and incomplete device history records. Read More
Devicemakers can improve their facility inspection experience by engaging in constructive conversations with agency investigators, an FDA official says. Read More
The Boston Scientific-sponsored report shows that 92 percent of patients received one revision over eight years at an average cost of $183,000. Read More
The i-Stat system measures the amount of hormone hCG in the blood stream and does not rely on urine, making it more attractive for emergency settings, company says. Read More