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Navigating the Regulatory Environment of Pharmaceutical Marketing: Balancing Patient Safety and Industry Innovation

Pharma Marketing Network

However, pharmaceutical marketing is also regulated by several agencies to ensure that patients are not exposed to false or misleading information. In this article, we will explore the regulatory environment of pharmaceutical marketing and how companies are navigating it to balance patient safety and industry innovation.

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Axial3D Receives FDA Clearance for Axial3D INSIGHT™ Medical Image Segmentation Platform

Legacy MEDSearch

Axial3D, a leader in medical segmentation and 3D solutions, today announced that it is the first to receive FDA clearance for an automated, AI-driven, cloud-based segmentation platform for orthopedic trauma, orthopedic, maxillofacial, and cardiovascular applications.

Medical 52
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NeuroLogica Announces FDA 510(k) Clearance of BodyTom® 64

Legacy MEDSearch

The BodyTom 64 brings the power of innovative imaging to patients’ bedsides safely and efficiently. BodyTom 64 is designed and manufactured to comply with the FDA Quality System Regulations and ISO 13485:2016 requirements and is in conformance with global regulatory harmonized standards. NeuroLogica Corp., Are you hiring?

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Ceribell Receives FDA 510(k) Clearance and CMS NTAP Reimbursement for New ClarityPro™ Software with Electrographic Status Epilepticus Diagnostic Indication

Legacy MEDSearch

Food and Drug Administration (FDA) for the indication of diagnosing Electrographic Status Epilepticus (ESE). The clearance follows prior receipt of Breakthrough Device Designation from FDA. Subsequent to receiving Breakthrough Device Designation and 510(k) clearance from FDA, the U.S. per eligible Medicare patient case.

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Hemosonics Awared FDA 510(k) Clearance for Quantra® Hemostasis System with QSTAT® Cartridge

Legacy MEDSearch

HemoSonics, LLC , a leading medical device company delivering individualized diagnostic solutions for Patient Blood Management (PBM), announced that it has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for the Quantra Hemostasis System with QStat Cartridge. market today.

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AccurKardia’s AccurECG™ Analysis System Receives FDA 510(k) Clearance

Legacy MEDSearch

AccurKardia , a medical technology company delivering clinical-grade ECG interpretation software, announced today that its flagship product, the AccurECG Analysis System (“AccurECG” or the “System”), has been granted FDA 510(k) clearance. It is indicated for adults aged 22 and older.

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iHealthScreen Inc. Announces FDA 510K Submission for iPredict™ AMD tool

Legacy MEDSearch

In its 510(k) application to the FDA iHealthScreen has proposed the following indication for iPredict’s use: iPredict-AMD is indicated for use by health care providers to automatically detect more than early age-related macular degeneration (mteAMD) in adults above 50 years of age who have not been previously diagnosed with Late AMD (i.e.,

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