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The European Academy of Paediatrics (EAP) and 22 other European medical associations have written to the European Commission (EC) to warn that critical pediatric medical devices are being squeezed out of the market by the high cost of implementing the EU Medical Device Regulation 745/2017 (EU MDR). Read More
A new FDA draft guidance details what to include in a submission for regulatory approval of patient-matched guides used in pre-surgical planning for 3-D printed orthopedic implant systems such as knee or hip replacements. Read More
When communicating about the efficacy and risks of prescription and OTC drugs directly to consumers, quantitative information “can improve consumers’ accuracy in estimating the drug’s benefits and risks” and should be “accurate and understandable” says the FDA in a final guidance issued Tuesday. Read More
I am good friends with a woman with Parkinson’s disease. When I see her, I feel grateful that this is the most exciting time in history for medical advancements. The drugs she is taking clearly are extending her good “on” time so that she has extended periods during the day when she can function with daily activities. I also have seen the difference between good “on” time and “off” time, when the medications start wearing off. Read More
Unauthorized sharing of users’ health data with several third parties — including Google — has gotten fertility app developer Easy Healthcare a $100,000 fine and a federal court order to protect consumer data. Read More
Two years after its repeal of a rule that would have expedited Medicare coverage for FDA-cleared Breakthrough Devices, CMA Thursday issued a request for comment on a process to provide “transitional coverage for emerging technologies” (TCET). Read More