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

Life Image Launches Real World Imaging for RWE Programs

by Jasmine Pennic 09/05/2019 Leave a Comment

Life Image Launches Real World Imaging for RWE Programs

- Life Image launches Real World Imaging (RWI) offering to respond to researcher needs for maturing insights and accelerating drug development decisions.  - Imaging data, especially for Real World Evidence (RWE), has historically been difficult, if not impossible, to access, retrieve, view, de-identify and normalize at-scale, even though it provides clinically material insights for a growing number of therapies. - Life Image represents the only company providing large, heterogeneous,
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Vocera Vina Smartphone App Launches to Optimize Patient Safety

by Jasmine Pennic 09/04/2019 Leave a Comment

Vocera Vina Smartphone App Launches to Optimize Patient Safety

- Vocera Vina smartphone app launches to help improve clinical communications and enhance patient safety by reducing the clerical burdens that lead to burnout. - The customizable communication app presents prioritized patient-centric calls, secure messages, and alerts in a unified inbox, and provides an intuitive user experience for clinicians inside and outside the hospital. - Drawing from the hospital EHR, this the vendor-agnostic platform works alongside all other Vocera products to
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How Tech Giants are Helping Providers Reinvent Patient Care

by Alyssa Rapp, CEO of Surgical Solutions 08/19/2019 Leave a Comment

How Tech Giants are Helping Providers Reinvent Patient Care

Healthcare costs are on the rise, and they show no signs of leveling off. According to the latest data available from the Centers for Medicare and Medicaid Services, healthcare spending in the United States reached $3.5 trillion in 2017, or $10,739 per person. Those costs are projected to rise by about five percent year-over-year. As expenditures continue to skyrocket, healthcare providers are looking to new technologies and care strategies that can help them treat patients more effectively at a
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FDA Cancer OCE, Syapse Partner on Regulatory Use of Real-World Evidence (RWE)

by Jasmine Pennic 08/14/2019 Leave a Comment

FDA Cancer COE, Syapse Partner on Regulatory Use of Real-World Evidence (RWE)

Syapse and the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) have signed a multi-year Research Collaboration Agreement (RCA) focused on the use of real-world evidence (RWE) to support regulatory decision-making. Syapse and the OCE will work with stakeholders across the FDA to address key regulatory questions about testing and treatment patterns, dosing and safety, and outcomes in oncology, with a focus on precision medicine.Methods to Derive RWE From Multiple
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OSF Ventures Joins $35M Funding Round for Handheld, Exo Ultrasound Device

by Fred Pennic 08/14/2019 Leave a Comment

OSF Ventures Backs $35M Series B Round for Handheld, Exo Ultrasound Platform

 OSF Ventures, the investment arm of OSF HealthCare has joined a $35M Series B funding round to support medical device startup Exo Imaging that’s developing a breakthrough handheld, AI ultrasound device that will allow healthcare providers to make critical, real-time diagnostic decisions.Performance Ultrasound PlatformFounded in 2015, Exo (pronounced “Echo”) is bringing diagnostic-grade medical imaging to the pocket of every caregiver and clinician worldwide. The company is developing an
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Mercy Launches a Nationwide Real-World Evidence (RWE) Network to Pool De-Identified Patient Data

by Jasmine Pennic 08/13/2019 Leave a Comment

Mercy Launches a Nationwide Real-World Evidence (RWE) Network

Mercy Technology Services (MTS), the information technology arm of St. Louis-based Mercy health system, has launched a nationwide real-world evidence network to pool clinical data for advanced analysis. The new initiative aims to create a new model of curated data sharing among providers, drug and device makers, regulators and more to power better patient care.MTS Real-World Evidence (RWE) Network BackgroundDeveloped in partnership with global tech giant SAP, MTS’ new network aims to tap into
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6 Ways Hospitals Can Benefit From E-Procurement Portals

by Boris Shiklo, CTO at ScienceSoft 08/13/2019 Leave a Comment

healthcare procurement: 6 Ways Hospitals Benefit from E-procurement

With regard to the increased complexity of healthcare procurement and the importance of sound supply chain control for ensuring a truly patient-centered approach, experts keep calling the hospitals to introduce advanced technologies for effective management of healthcare procurement and supplies. Procurement portals, as one of those, already greatly add to the effectiveness of purchasing across various retail and manufacturing companies allowing for simplified and optimized management of
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What’s AI’s Holdup in Healthcare? The Answer Is In The Cloud

by Fabien Beckers, Ph.D., CEO, Arterys 08/13/2019 Leave a Comment

What’s AI’s Holdup in Healthcare? The Answer Is In The Cloud

When you consider what technology has the most potential to transform healthcare over the next decade and beyond, no doubt your first thoughts turn to artificial intelligence (AI), machine learning (ML) and deep learning (DL). Already these technologies are showing promise in helping clinicians work faster and smarter, identifying trends, alerting us to signs that can predict and prevent diseases, and providing insights into potential treatments and cures.  But AI, ML, and DL alone cannot
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Ethical Concerns of AI in Healthcare: Can AI Do More Harm Than Good?

by Erica Garvin 08/06/2019 Leave a Comment

Before the AI Doctor, Ethics Must in Place

The AI doctor can see you now, but it shouldn't treat you until ethics are in place. Professor Timothy Casey explains. Artificial Intelligence (AI) and ethics—once mythical adversaries only on-screen like in “The Terminator” circa 1984— are now actually at virtual odds in 2019. This time, there are no catchy slogans like Arnold Schwarzenegger’s “I’ll be back,” but the moral question has returned: Does AI’s transformative power have the ability to do more harm to humankind than good? That is the
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What Is The Upside of Establishing Extended Reality As A Medical Device?

by Eran Orr, Founder of XRHealth 07/31/2019 Leave a Comment

Extended Reality (XR) as a Medical Device

XR stands for extended reality. Basically, it's an umbrella term covering the VR (virtual reality), AR (augmented reality), and MR (mixed reality) technologies. All three are already involved or will be involved in healthcare. In the very near future, you will be able to “swipe” between all three within an application. Different combinations of the technologies will be used to provide specific health benefits, eventually all within a single platform. It is sometimes hard to explain to people
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