MedCity Influencers

The FDA’s review of breast implant safety guidelines (Best of MedCitizens)

Every week, MedCity News highlights the best of its MedCitizens: syndication partners and MedCity News readers who discuss life science current events on MedCityNews.com. Now here's the best of what YOU had to say:

Every week, MedCity News highlights the best of its MedCitizens: syndication partners and MedCity News readers who discuss life science current events on MedCityNews.com.

Now here’s the best of what YOU had to say:

FDA breast implant guidance: It doesn’t go far enough. “Several advisory panel members said the FDA’s requirement that women have frequent MRIs to make sure the implants haven’t ruptured is unrealistic and should be removed from the product label. Insurance usually doesn’t pay for the scans, so most women don’t get them done. But it’s the only way to find out whether the implant has ruptured in the absence of symptoms.”

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Assessing what’s happening in ENT (ear, nose and throat). “There are other areas in ENT that are promising, yet have been completely overlooked and untapped. Otology (ear related disorders) and laryngology (diseases of the throat) remain a challenge for treatment and represent the new, emerging markets.”

Unsuccessful Stryker brain stent shows flaws in device development, approval. “The company should be asked to reimburse the taxpayers. And this episode shows that the FDA’s device approval process should be made more stringent to require the same kind of trials for devices that it now requires of drugs ’ the trials that prove with statistical significance that new products do in fact improve public health.”

Clinician culture shifting, embracing EHRs and HIEs. “For the first time in my career, I am seeing a cultural transformation such that the majority of clinicians believe an EHR is a necessary part of their practice. Emerging accountable care organizations are stressing the need for health information exchange and financial/clinical analytics as a foundation for the healthcare reform work ahead.”

Health IT innovators and providers collide at eHealth summits.The New England Summit is also rolling out the eHealth Innovation Open, which seeks, through competition, to recognize outstanding new health information technology solutions, with “speed-dating” sessions matching top innovative healthcare and solution providers.”

Deanna Pogorelc is a Cleveland-based reporter who writes obsessively about life science startups across the country, looking to technology transfer offices, startup incubators and investment funds to see what’s next in healthcare. She has a bachelor’s degree in journalism from Ball State University and previously covered business and education for a northeast Indiana newspaper.

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