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Discussions demonstrate strong agreement with the article's concerns, highlighting that many cardiovascular devices lacked proper clinical testing prior to approval, with phrases like 'little clinical evidence' and 'serious safety recalls.' The tone emphasizes urgency and policy impact, reflecting high interest and engagement among participants who refer to the limitations of device approval processes.
The majority of discussions agree that the article highlights a concerning lack of clinical evidence for recalled devices, emphasizing the risks involved.
Posts show high interest, with many referencing the lack of clinical testing and calling for regulatory reforms, indicating strong engagement with the topic.
Several comments analyze the implications of the findings and cite specific studies or policy concerns, demonstrating meaningful engagement.
The discussions suggest the article could influence public awareness and regulatory practices, as users emphasize safety issues and potential policy changes.
@AnnalsofIM @UCSFDOM @see_laudia @hmkyale @jsross119 @MaryamMooghali @US_FDA @ZekeEmanuel (9/9) Be sure to check out the full paper @AnnalsofIM https://t.co/TyZh0Pudvp CC: @harvardmed @YaleMed @Yale_CRRIT @UCSFDOM
Class I Recalls of Cardiovascular Devices Between 2013 and 2022: A Cross-Sectional Analysis https://t.co/ZrI5omeERT https://t.co/IFyHc5Wm5F
New Paper
Most cardiovascular devices subject to Class I recalls did not undergo pre-auth clinical testing & were not required to undergo post-market surveillance studies: https://t.co/05c2uIcFMP @HarvardMed @YaleMed @UCSF https://t.co/o9zte2kxqI
Most Recalled Cardiovascular Devices Gained FDA Approval With Little to No Clinical Evidence. https://t.co/8Oa92sMk5u
ICYMI: Most cardiovascular devices subject to Class I recalls did not undergo pre-auth clinical testing & were not required to undergo post-market surveillance studies: https://t.co/05c2uIcFMP @HarvardMed @YaleMed @UCSF https://t.co/PKisx7IqjV
This week, John Mandrola MD reviews reader feedback on cardiac devices and discusses the new 'occlusion MI' paradigm transforming acute myocardial infarction diagnoses. Explore how advanced ECG methods and AI improve…
Cardiovascular devices account for about one-third of all FDA Class I recalls from 2013 to 2022, highlighting significant safety risks. This analysis discusses design issues, reliance on surrogate endpoints, and limited…
RT @Contrafatto: Most Recalled Cardiovascular Devices Gained FDA Approval With Little to No Clinical Evidence. https://t.co/8Oa92sMk5u
Most Recalled Cardiovascular Devices Gained FDA Approval With Little to No Clinical Evidence. https://t.co/8Oa92sMk5u
New Paper
RT @AnnalsofIM: ICYMI: Most cardiovascular devices subject to Class I recalls did not undergo pre-auth clinical testing & were not required…
ICYMI: Most cardiovascular devices subject to Class I recalls did not undergo pre-auth clinical testing & were not required to undergo post-market surveillance studies: https://t.co/05c2uIcFMP @HarvardMed @YaleMed @UCSF https://t.co/PKisx7IqjV
Most cardiovascular devices subject to Class I recalls did not undergo pre-auth clinical testing & were not required to undergo post-market surveillance studies: https://t.co/05c2uIcFMP @HarvardMed @YaleMed @UCSF https://t.co/o9zte2kxqI
@AnnalsofIM @UCSFDOM @see_laudia @hmkyale @jsross119 @MaryamMooghali @US_FDA @ZekeEmanuel (9/9) Be sure to check out the full paper @AnnalsofIM https://t.co/TyZh0Pudvp CC: @harvardmed @YaleMed @Yale_CRRIT @UCSFDOM
recalled medical devices "often had little clinical evidence supporting their original authorization" Class I Recalls of Cardiovascular Devices Between 2013 and 2022: A Cross-Sectional Analysis: Annals of Internal Medicine: Vol 0, No 0 https://t.co/ji1IFY1Zj3
RT @AshuPJadhav: Class I Recalls of Cardiovascular Devices Between 2013 and 2022: A Cross-Sectional Analysis https://t.co/ZrI5omeERT https:…
Class I Recalls of Cardiovascular Devices Between 2013 and 2022: A Cross-Sectional Analysis https://t.co/ZrI5omeERT https://t.co/IFyHc5Wm5F
@dr_benoy_n_shah @TCTMD_Caitlin @TCTMD relatedly, & I think related to a blog article that you wrote about device regulation too- (I think it was you, but I can't find it now...), this is a great study that was published today via @AnnalsofIM by @hmkyale et al: https://t.co/66uP2AxkTo $gated
Most #cardiovascular devices with serious #safety recalls aren’t tested in patients https://t.co/bSO3sIpkCS via @statnews https://t.co/WFPS2Sxq2M
Just out in @AnnalsofIM A study of CVD devices subject to Class I recalls from 2013 through 2022 found that most recalled devices did not undergo clinical testing prior to authorization & were not required to undergo postmarket surveillance studies. https://t.co/BeD2kRBeLx