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Book Review: ‘Drugs and the FDA: Safety, Efficacy, and the Public’s Trust’ by Mikkael A. Sekeres

Bill of Health

In Drugs and the FDA: Safety, Efficacy, and the Public’s Trust , oncologist Mikkael A. Sekeres centers his narrative on the controversial 2011 Avastin hearings , in which the FDA reconsidered and ultimately withdrew the breast cancer indication for Genentech’s Avastin drug.

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Federal Court of Appeals Panel Issues Ruling in Litigation Challenging FDA Approval of Mifepristone

Hall Render

Food & Drug Administration (“FDA”) approval and regulation of mifepristone (brand name Mifeprex), a drug used in medically induced abortions. The panel vacated in part and affirmed in part a decision by a District Court judge in Texas that would have suspended the FDA’s approval of mifepristone. Jackson Women’s Health.

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‘Care Anywhere’ is the new normal, according to new industry report

Healthcare It News

Another result concerns innovation through ‘femtech’: digital technologies and applications related to women’s health are increasingly gaining importance – more so as this has been a gap in care in the US with only three per cent of all health deals since 2011 focusing on this area.

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‘Care Anywhere’ is the new normal, according to industry report

Healthcare It News

Another result concerns innovation through ‘femtech’: digital technologies and applications related to women’s health are increasingly gaining importance – more so as this has been a gap in care in the US with only three per cent of all health deals since 2011 focusing on this area.

COVID-19 221
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Stryker Acquires Med Device Company Gauss Surgical

HIT Consultant

Founded in 2011, Gauss’s mission is to digitally augment clinicians with software that radically improves diagnostic accuracy and leads to improved patient safety and clinical outcomes. Food and Drug Administration (FDA) in 2014, as the first-ever computer vision software for surgical use, and several follow-on 510(k) clearances.

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Fear and Confusion Over the Software and Artificial Intelligence Revolution Reaches the FDA

Healthcare IT Today

What passes for a moderate observation is the 2011 statement by Marc Andreessen that “Software is eating the world.” Society is being doubly convulsed by the revolutions of software and artificial intelligence. ” At the more extreme end, people dread a future envisioned by the Terminator and Matrix movies.

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Podimetrics Secures $45M for SmartMat to Prevent Diabetic Amputations in High-Risk Patients

HIT Consultant

Founded in 2011 by a physician and engineers from MIT and Harvard, Podimetrics developed the SmartMat — the only easy-to-use, an at-home mat that a patient steps on for 20 seconds per day. The FDA-cleared and HIPAA-compliant SmartMat are remotely monitored by Podimetrics’ in-house nurse support team.

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