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NeuroLogica Announces FDA 510(k) Clearance of BodyTom® 64

Legacy MEDSearch

a subsidiary of Samsung Electronics Co. Food and Drug Administration for commercial use in the United States. Director of Global Sales and Marketing of NeuroLogica. the healthcare subsidiary of Samsung Electronics Co., NeuroLogica Corp., About NeuroLogica. NeuroLogica Corp., Press Release by: NeuroLogica.

FDA 92
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Lazurite is Recognized in the 2022 Medical Device Network Excellence Awards & Rankings for its ArthroFree™ System

Legacy MEDSearch

Food and Drug Administration market clearance for the ArthroFree System. This was followed by additional partnerships with Hospital for Special Surgery (HSS) in New York, University Hospitals of Cleveland, and LG Electronics USA.”. “We “The company hit an important milestone in March 2022 when it received U.S.

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Pharmacovigilance deep dive: risk minimisation measures

European Pharmaceutical Review

An RMP is submitted as part of the dossier of all new drug applications and is evaluated by regulatory authorities before authorisation is given. Jouaville: Most RMM effectiveness studies are formatted as surveys or drug utilisation studies (DUS). US Food and Drug Administration. Available from: [link].

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Transforming pharmaceutical manufacturing: The AI revolution

European Pharmaceutical Review

Accelerated drug discovery: Simulations and predictive models powered by AI will speed up the drug development process, effectively slashing time to market for drugs. Internet] US Food and Drug Administration (FDA). Artificial Intelligence and Machine Learning in Software as a Medical Device.

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UroMems Announces First-Ever Smart Artificial Urinary Sphincter Implant in a Female Patient

Legacy MEDSearch

Food and Drug Administration). Food and Drug Administration (FDA) for UroActive. STeP is a collaborative program intended to help reduce the time it takes to develop and obtain marketing authorization for eligible devices. Christophe Vaessen.

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Prioritising for a data-driven 2023

European Pharmaceutical Review

However, a good many companies are not yet well set up for this” In terms of drug development and clinical trials, EU Clinical Trial Regulation and more specifically the Clinical Trial Information System (CTIS) presented one of the main practical changes of 2022. Improvements were also seen in the drug development process itself.

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NITROSAMINES: Where now?

European Pharmaceutical Review

The US Food and Drug Administration (FDA) subsequently developed a liquid chromatography – high resolution mass spectroscopy (LC-HRMS) method for the determination of NDMA in ranitidine. 1,2 The second occurrence of NDMA arising from degradation was in metformin drug product. FDA assigned a provisional AI of 26.5