Left to their own devices: breakdowns in United States medical device premarket review. - Wikidata - wikimedia - TriplyDB

Left to their own devices: breakdowns in United States medical device premarket review.

Left to their own devices: breakdowns in United States medical device premarket review.

http://www.wikidata.org/entity/Q33633943

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Alternating current cranial electrotherapy stimulation (CES) for depression Alternating current cranial electrotherapy stimulation (CES) for depression Generating appropriate clinical data for value assessment of medical devices: what role does regulation play?Medical device regulation: time to improve performance.Understanding FDA regulation of DTC genetic tests within the context of administrative law.Performance of propensity score methods when comparison groups originate from different data sources.Medical device assessment: scientific evidence examined by the French national agency for health - a descriptive study US Food and Drug Administration Regulation of Medical Devices and Radiation Oncology: Can Reform Improve Safety?Adverse Events Involving Radiation Oncology Medical Devices: Comprehensive Analysis of US Food and Drug Administration Data, 1991 to 2015.Medical Device Recalls in Radiation Oncology: Analysis of US Food and Drug Administration Data, 2002-2015.A Road Map to Commercialization of Cartilage Therapy in the United States of America.Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study.Improving medical device regulation: the United States and Europe in perspective.Assessing the cost burden of United States FDA-mandated post-approval studies for medical devices.Regulating molecular diagnostic assays: developing a new regulatory structure for a new technology.Pre-market clinical evaluations of innovative high-risk medical devices in Europe.US Food and Drug Administration Clearance of Moderate-Risk Otolaryngologic Devices via the 510(k) Process, 1997-2016.Teaching Hospitals and the Disconnect Between Technology Adoption and Comparative Effectiveness Research: The Case of the Surgical Robot.Introduction of high-risk medical devices: national measures that can be taken under the current European legislation to put the patient interest central.The regulatory ancestral network of surgical meshes.

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Left to their own devices: breakdowns in United States medical device premarket review.

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Left to their own devices: breakdowns in United States medical device premarket review.

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Jonas Zajac Hines

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Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial.

Vagus nerve stimulation for treatment-resistant depression: a randomized, controlled acute phase trial.

Medical device regulation: an introduction for the practicing physician.

Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices.

Intra-aortic balloon counterpulsation in US and non-US centres: results of the Benchmark Registry.

Daily left prefrontal repetitive transcranial magnetic stimulation in the acute treatment of major depression: clinical predictors of outcome in a multisite, randomized controlled clinical trial.

Premarket clinical evaluation of novel cardiovascular devices: quality analysis of premarket clinical studies submitted to the Food and Drug Administration 2000-2007.

Elevated risk of pelvic inflammatory disease among women using the Dalkon Shield.

Reply to Lisanby et al. Post hoc analysis does not establish effectiveness of rTMS for depression.

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