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Cerner Enviza and FDA partner to develop AI drug safety tools

Pharmaceutical Technology

Oracle company Cerner Enviza and John Snow Labs have collaborated with the US Food and Drug Administration (FDA) for the development of artificial intelligence (AI) tools for drug safety and real-world evidence studies.

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ReCor Medical Announces Two Concurrent JAMA Network Publications of Study Results on the Paradise Ultrasound Renal Denervation System for the Treatment of Hypertension

Legacy MEDSearch

In addition, pooled analysis results from the combined primary efficacy endpoint and safety data from RADIANCE SOLO, RADIANCE TRIO, and RADIANCE II were concurrently published in JAMA Cardiology. The study also achieved its primary safety composite outcome with no major adverse events observed. mmHg, compared to a reduction of -1.8

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Why Is FDA Issuing Fewer Marketing Violation Letters?

Pharma Marketing Network

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled.

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FDA Awards HistoSonics Clearance of its First-of-a-Kind Edison® Histotripsy System

Legacy MEDSearch

Food and Drug Administration’s (FDA) De Novo Classification Request process, a rigorous pre-market review pathway for medical devices with no existing predicate. FDA authorization was based, in part, on data from the #HOPE4LIVER Trials in 13 trial sites across the US and Europe.

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Techsomed Announces FDA Clearance for Ablation Treatment Planning and Confirmation Software

Legacy MEDSearch

a medical software innovator dedicated to enhancing clinical impact in ablation therapy, announced today that it has received 510(k) clearance from the USA Food and Drug Administration (FDA) for its VisAble.IO Techsomed Ltd., “We are excited to receive 510(k) clearance for our VisAble.IO The BioTrace.IO

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Hip Innovation Technology Announces Initiation of FDA Approved Investigational Device Exemption Study

Legacy MEDSearch

implantation of the HIT Reverse Hip Replacement System (Reverse HRS), under an FDA approved Investigational Device Exemption (IDE). The IDE Study is being conducted to determine the safety and effectiveness of the HIT Reverse HRS in Primary Total Hip Arthroplasty (THA). Press Release by: Hip Innovation Technology. Are you hiring?

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FDA Approves Innovative 4D Flow MRI Blood Flow Analysis Software from Cardio Flow Design Inc.

Legacy MEDSearch

The FDA approval is significant as it recognizes the safety and effectiveness of iTFlow® in analyzing blood flow through 4D Flow MRI data, with the potential to enhance diagnostic accuracy for patients with cardiovascular diseases and heart conditions. iTFlow® is an innovative software solution developed by Cardio Flow Design Inc.

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