Primary Care Corner with Dr. Geoffrey Modest: Devices less regulated/proven than Medications

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these 2 headlines came across my desk.  related?? turns out that medical devices much less regulated than drugs.  Geoff

 

Big Changes to Heart Devices OK’d Without New Data   
Many of the high-risk implantable cardiac devices in use today were approved through a supplement pathway that does not require new clinical data on the safety and effectiveness of changes made to the products since their original approval, a review of an agency database showed. Read more

 

Dangerous Rapid Calcification Observed in Pediatric Patients After Aortic Valve Replacement

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