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PolarisAR Receives Clearance from the U.S. Food and Drug Administration for Stellar Knee

Legacy MEDSearch

Food and Drug Administration (FDA). These technologies, while delivering important data that can be used to personalize the operation for each patient, require a large footprint in my OR and a significant financial commitment from my institution.

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The potential of virtual reality-based therapy for serious mental disorders

Pharmaceutical Technology

In June this year, it was announced that the US Food and Drug Administration (FDA) had granted UK-based OxfordVR a breakthrough device designation for its gameChangeVR treatment to deliver immersive cognitive behaviour therapy (CBT) to people suffering from schizophrenia and other mental illnesses.

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

Legacy MEDSearch

Food and Drug Administration for commercial use in the United States. The BodyTom 64 brings the power of innovative imaging to patients’ bedsides safely and efficiently. the healthcare subsidiary of Samsung Electronics Co., NeuroLogica Corp., Press Release by: NeuroLogica.

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

Legacy MEDSearch

Food and Drug Administration (FDA) for the indication of diagnosing Electrographic Status Epilepticus (ESE). per eligible Medicare patient case. ClarityPro is now the only FDA-indicated device for the diagnosis of ESE in adult patients over the age of 18. Ceribell, Inc. NTAP reimbursement of up to $913.90

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Ancora Heart Receives Breakthrough Device Designation from FDA for the AccuCinch® Ventricular Restoration System

Legacy MEDSearch

Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the AccuCinch ® Ventricular Restoration System. This program is designed to ensure patients and healthcare providers have more timely access to these medical devices. Ancora Heart , Inc., An estimated 6.5 million U.S.

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Diversity and inclusion in oncology clinical trials

Clarify Health

Food and Drug Administration (FDA) released guidance entitled, Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. To advance equity in clinical research, the U.S. However, another study found that 0.1% 2] Figure 1. 2] Figure 1.