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FDA Ends Months-Long FOIA Battle Over Medical Device Failures, Says Putting Database Online ‘Satisfies’ KHN Request

The Meals and Drug Administration responded Wednesday to a Freedom of Data Act request filed months in the past, noting that the data sought by Kaiser Well being Information “is now posted on-line.” KHN had filed a collection of FOIA requests, starting in September 2018, in search of hidden experiences …

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More Than Half Of Surgical Stapler Malfunctions Went To Hidden FDA Database

The Meals and Drug Administration has acknowledged that greater than 56,000 never-before-disclosed surgical stapler malfunctions had been quietly reported to the company from 2011 by means of 2018. The newly acknowledged experiences had been detailed in an government abstract for FDA advisers. The company convened a gathering of consultants this …

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Hidden Reports Masked The Scope Of Widespread Harm From Faulty Heart Device

Confronted with the likelihood bout of irregular heartbeats might finish his life, in 2006, Dr. Marc Sicklick had a small gadget implanted in his chest that may shock it again into rhythm. Quickly he would wrestle with one other life-or-death selection: whether or not to take away the Dash Fidelis, …

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FDA To End Program That Hid Millions Of Reports On Faulty Medical Devices

The Meals and Drug Administration introduced it’s shutting down its controversial “different abstract reporting” program and ending its decades-long follow of permitting medical gadget makers to hide hundreds of thousands of studies of hurt and malfunctions from most people. The company stated it should open previous information to the general …

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Watch: Price of a Brace Brings Soccer Player to His Knees

April 18, 2019 Telemundo Information featured KHN’s latest Invoice of The Month story a couple of soccer participant who was caught paying huge bucks for a elaborate hinged knee brace. Paula Andalo, KHN’s ethnic media editor, provided recommendation about how you can keep away from overpaying for medical gear you …

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Readers And Tweeters Chime In On Investigation Of Electronic Health Records

Letters to the Editor is a periodic characteristic. We welcome all feedback and can publish a variety. We edit for size and readability and require full names. Empowered by the digital revolution, the U.S. authorities claimed that turning American medical charts into digital information would make well being care higher, safer and …

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FDA Chief Calls For Release Of All Data Tracking Problems With Medical Devices

FDA Commissioner Scott Gottlieb introduced in a tweet Wednesday that the company plans to launch lots of of hundreds, if not tens of millions, of beforehand unpublished damage and malfunction studies tied to about 100 medical units. “We’re now prioritizing making ALL of this knowledge out there,” Gottlieb tweeted. That …

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Device-Safety Experts To FDA: Make Data Public

Medical machine security researchers are calling on the Meals and Drug Administration to launch lots of of 1000’s of hidden damage and malfunction studies associated to about 100 medical units. A latest Kaiser Well being Information investigation revealed that the FDA granted machine makers quite a few “exemptions” from the …

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FDA Announces Sweeping Plan To Review Safety Of Surgical Staplers

Use This Story This story will be republished free of charge (particulars). The Meals and Drug Administration introduced a sweeping plan on Friday to evaluation and tackle the protection of surgical staplers, together with a brand new examination of seven years’ price of hidden stories highlighted Thursday in a Kaiser …

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Medical Device Makers Report Malfunctions And Patient Injuries In FDA Database Hidden From Public ViewKaiser Health News

Dr. Douglas Kwazneski was serving to a Pittsburgh surgeon take away an appendix when one thing jarring occurred. The surgical stapler meant to chop and seal the tissue across the appendix locked up. Kwazneski later turned to the Meals and Drug Administration’s public database that tracks medical gadget failures and …

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