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The FDA handed Noven Pharmaceuticals a 13-item Form 483 for lapses in batch reviews and testing, stability and process controls and complaint handling. Read More
The FDA is advising healthcare professionals to strictly follow the instructions for use for cranial perforators with automatic clutch mechanisms following reports of more than 200 injuries related to their use. Read More
Failure to inform the FDA about a medical device correction or removal has earned Merge Healthcare, a developer of medical image handling and processing, interoperability and clinical systems, a warning letter. Word of the letter came just as IBM closed its deal to buy Merge, which will become part of IBM’s new Watson Health business for $1 billion. Read More
Theranos, a hot startup that recently received media scrutiny regarding its testing system, has been hit with two 483s, one of which takes the company to task for shipping an uncleared device. Read More