2016 was a big year for medical device recalls, with the number of units recalled in the third quarter reaching the highest level in four years. Here are the 10 recalls that impacted the most medical device units in the United States.
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FDA launched two major initiatives in 2016—cybersecurity requirements and a national system for real-world device monitoring.
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Patent protections for Software as a Medical Device are increasingly important due to the additional investments in clinical evaluation that may be needed to withstand the FDA scrutiny under the new draft guidelines.
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