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The FDA cancelled an advisory committee meeting scheduled last Wednesday to consider the premarket approval application for a TransMedics donor heart care system. Read More
Citing continued violations of a 2007 consent decree, the FDA has ordered Custom Ultrasonics to recall all 2,800 automated endoscope reprocessors in hospitals and outpatient clinics in the U.S. Read More
Roughly three months after the European Medicines Agency announced it was seeking additional information on the InductOs implant marketed by a Medtronic unit, the health body has recommended the suspension of the product. 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
With negotiations on the fourth installment of the Medical Device User Fee Amendments moving ahead, medical device companies appear to be pleased with how the process is progressing, at least according to one industry insider. Read More
A Federal Communications Commission proposal to amend hearing aid compatibility rules is coming under fire from one commissioner, who is concerned that some of the ideas expressed in the plan would allow for “inappropriate” FCC intervention in the standards development process. Read More
A lawmaker is taking the FDA to task after a Government Accountability Office report determined that more than 70 percent of postapproval studies ordered by the agency since January 2007 are ongoing. Read More
The European Commission should take additional steps to ensure that experts sitting on scientific committees that make decisions on medical products are truly independent. Read More
The UK’s health cost-benefit watchdog is calling for further research on two tests that could help diagnose preeclampsia in the second and third trimesters of pregnancy. Read More