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FDA| Healthcare FDA Regulation | Policy, News, Analysis, Insights - HIT Consultant

KLAS: Clinical Decision Support Point-of-Care Reference 2022

by Syed Hamza Sohail 12/15/2022 Leave a Comment

KLAS: Clinical Decision Support Point-of-Care Reference 2022

What You Should Know: - CDS reference tools enable clinical users to follow standard treatment recommendations and more quickly and confidently make clinical decisions. However, tools that lack strong content, searchability, and EMR integration are not efficient for point-of-care workflows and can frustrate users, especially those already experiencing burnout. - To understand the customer experience and how each solution is being adopted, a new report by KLAS draws on feedback from a
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BehaVR & Oxford VR Merge, Raises $13M for VR Delivery Platform

by Fred Pennic 12/13/2022 Leave a Comment

BehaVR & Oxford VR Merge, Raises $13M for VR Delivery Platform

What You Should Know: - Virtual reality mental and behavioral health companies BehaVR and OxfordVR today announced their merger, supported by an initial $13M in Series B funding led by Optum Ventures and Oxford Science Enterprises, with participation from Confluent Health, Accenture Ventures, Chrysalis Ventures and Thornton Capital. - Uniting under the BehaVR brand, digital therapeutic companies BehaVR and OxfordVR will deliver comprehensive virtual reality-based treatments for mental and
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Primary Care Shifts to Pharmacy and Retail Clinic Settings, Survey Reveals

by Syed Hamza Sohail 12/12/2022 Leave a Comment

Primary Care Shifts to Pharmacy and Retail Clinic Settings, Survey Reveals

What You Should Know: - Primary care is continuing to decentralize with more decisions made outside of primary care offices, according to a recent report by Wolters Kluwer. - The Pharmacy Next: Health Consumer Medication Trends survey explores consumer sentiment amid this shift, and offers insight into what safeguards are needed to address their top concerns around medication-related care.  Research-Driven Prospects Regarding Changes in American Primary Healthcare The Pharmacy Next:
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AI/ML Used for Clinical Trial-Site Identification Simultaneously Improves Enrollment Rates and Diversity

by Lucas Glass, VP of the Analytics Center of Excellence (ACOE), IQVIA 12/12/2022 Leave a Comment

AI/ML Used for Clinical Trial-Site Identification Simultaneously Improves Enrollment Rates and Diversity

Ethnic and racial minorities are commonly underrepresented in clinical trials. This problem is so severe that in April, the U.S. Food and Drug Administration (FDA) expanded upon existing guidance to further emphasize recommendations to sponsors developing treatments to increase enrollment from underrepresented populations in the U.S., including African-American, Hispanic, Asian and other persons of color, in clinical trials. In the updated guidance, the FDA provided details on what sponsors
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VA Provides Veterans with Immersive, VR Treatment for Chronic Lower Back Pain

by Fred Pennic 12/09/2022 Leave a Comment

VA Provides Veterans with Immersive, VR Treatment for Chronic Lower Back Pain

What You Should Know: - AppliedVR, an immersive therapeutics (ITx) pioneer advancing a novel, virtual reality-based approach to medicine, today announced a contract with the U.S. Department of Veterans Affairs (VA) to provide its FDA-authorized RelieVRx (formerly EaseVRx) solution to select Veterans impacted by chronic lower back pain (CLBP). - AppliedVR was awarded the contract with the VHA Innovation Ecosystem, a division of the VA that discovers, evaluates, and
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Inventory Management Systems Bolster Hospital Cost Savings Initiatives

by Todd Plesko, General Manager, Syft, a GHX company 12/09/2022 Leave a Comment

Inventory Management Systems Bolster Hospital Cost Savings Initiatives

For many hospitals and health systems, it’s been another challenging year. Increases in patient volume and modest revenue gains haven’t been enough to offset the impact of labor shortages and an inflation rate that reached a historic high in June. A recent Kaufman Hall report found most healthcare organizations had negative operating margins for the first half of 2022 due in large part to historically high expenses.   In the face of these ongoing operating losses, the industry has
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Dexcom Receives FDA Clearance for G7 Continuous Glucose Monitoring (CGM) System

by Jasmine Pennic 12/08/2022 Leave a Comment

Dexcom Receives FDA Clearance for G7 Continuous Glucose Monitoring (CGM) System 

What You Should Know: - The FDA has cleared Dexcom G7 continuous glucose monitoring (CGM) system in the U.S. for people with all types of diabetes ages two years and older, giving more people than ever access to a powerfully simple diabetes management solution. - Cleared as an integrated continuous glucose monitoring (iCGM) system, Dexcom G7 will be part of the most connected CGM ecosystem in the world, with real-time connectivity that can drive integrated insulin delivery systems, connect
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Aetion, FDA to Evaluate Real-World Data Standardization for COVID-19

by Fred Pennic 12/07/2022 Leave a Comment

Aetion, FDA to Evaluate Real-World Data Standardization for COVID-19

What You Should Know: - Aetion, a provider of real-world evidence (RWE) technology and analytics, today announced that the FDA has extended Aetion’s contract to evaluate real-world data (RWD) involving COVID-19 medical countermeasures. - Aetion will be expanding its work to evaluate data standardization in the context of COVID-19. Aetion has been collaborating with FDA since May 2020, providing validated software platform capabilities and RWD/E expertise to contribute to rapid evidence
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Enthea Secures $2M to Expand Psychedelic Healthcare Provider Network

by Fred Pennic 12/06/2022 Leave a Comment

Enthea Nabs $2M to Expand Psychedelic Healthcare Provider Network

What You Should Know: - Enthea, the first provider of insurance plans for psychedelic healthcare, has announced a $2M Seed Round raise led by Tabula Rasa Ventures to offer psychedelic-assisted therapy as a workplace benefit. - The funds will be used to launch Enthea’s services into 40 markets across the U.S. in 2023 as well as grow its customer base and provider network to increase access to new, evidence-based healing options that have proven to be very effective in improving symptoms for
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Virta Health Helps AutoZone Employees Reverse Type 2 Diabetes

by Jasmine Pennic 12/01/2022 Leave a Comment

AutoZone Partners With Virta Health to Help AutoZoners Reverse Type 2 Diabetes and Prediabetes

What You Should Know: - Type 2 diabetes reversal leader Virta Health revealed promising one-year outcomes from its partnership with AutoZone, Inc., a retailer and distributor of automotive replacement parts and accessories in the Americas. - Virta provides virtual, continuous health coaching, medical supervision and personalized nutrition to help patients reverse their metabolic disease, lose weight, + get off medications. At one year, AutoZoners experience long-term blood sugar control
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