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Understanding the FDA Debarment List

Compliancy Group

One primary aspect of compliance is ensuring you are checking the FDA debarment list to verify that those involved in your operations aren’t essentially banned from working in the drug industry. The purpose of this list is to help businesses stay within compliance with FDA regulations and to safeguard public health.

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GrayMatters Health Expands FDA-Cleared PTSD Treatment Expands to US Clinics

HIT Consultant

– As the first FDA-cleared self-neuromodulation device for post-traumatic stress disorder (PTSD), Prism for PTSD™ offers a new approach to managing this debilitating condition. Broad Impact: A new analysis presented at the International Society for Traumatic Stress Studies showed significant effects across all PTSD symptom clusters.

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GE HealthCare Receives FDA Clearance for Innovative Alzheimer’s Imaging Tool

HIT Consultant

Food and Drug Administration (FDA) for a groundbreaking tool in the fight against Alzheimer’s disease. This streamlined process generates quantitative results, presented in a standardized report alongside the images.

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AccurKardia’s AI-Powered ECG Software Earns FDA Breakthrough Device Designation for Aortic Stenosis Detection

HIT Consultant

Food and Drug Administration (FDA). With its initial focus on cardiology, AccurKardia provides innovative cloud-based diagnostic tools, including AccurECG™4, an FDA-cleared Class II software as a medical device (SaMD) that offers fully automated, near real-time ECG interpretation.

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FDA Issues Final Guidance on Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertising

Hall Render

The Final Guidance provides recommendations on how to enhance consumer comprehension of promotional materials by making the language and presentation of quantitative information more accessible and consumer-friendly across various media formats. 57 out of 100) or percentages (57%). 57 out of 100) or percentages (57%).

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FDA releases draft guidance for Breakthrough Devices Program aimed at health inequities

Mobi Health News

When determining approval for Breakthrough Device designation, the FDA will consider whether the device addresses present health inequities.

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FDA Selects Ontada to Investigate Rare Cancers Treated in US Community Oncology Setting

HIT Consultant

Food and Drug Administration (FDA) to advance the use of real-world data (RWD) in the U.S. Study Goals & Objectives The goal of the study is to better understand how patients with rare cancers present and are treated to inform drug development for life sciences companies and the FDA. community oncology setting.

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