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

4 Predictions for Diabetes Management and Technology in 2021

by Jordan Messler, MD, SFHM, FACP, Executive Director, Clinical Practice, Glytec 01/08/2021 Leave a Comment

Is Glucometrics The Missing Data in the Fight Against COVID-19?

The COVID-19 pandemic continues to put an unprecedented amount of strain on the entire healthcare sector, and the industry has responded by accelerating the ways innovation is developed and adopted. Health leaders have faced a generational challenge and the result has been the rapid deployment of technology to address dire patient needs. Health systems, physicians, and frontline staff pulled together in remarkable fashion to implement these emerging technologies that enhance the ways patients
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TigerConnect Acquires Hospital Middleware Solution Critical Alert – M&A

by Fred Pennic 01/06/2021 Leave a Comment

M&A: TigerConnect Acquires Hospital Middleware Solution Critical Alert

What You Should Know: - TigerConnect has announced an expansion in their suite through the acquisition of Critical Alert, a leading provider of enterprise-grade middleware for hospitals and health systems. - For the hundreds of thousands of nurses that currently use TigerConnect, these new capabilities will deliver real-time, contextual information to their mobile device or desktop to allow them to work smarter, prioritize responses, and efficiently coordinate care, all within the
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AMA Adds 3 Additional CPT Codes for AstraZeneca’s COVID-19 Vaccine

by Fred Pennic 12/24/2020 Leave a Comment

AMA Adds 3 Additional CPT Codes for AstraZeneca's COVID-19 Vaccine

What You Should Know: - The American Medical Association (AMA) announced the addition of three Current Procedural Terminology (CPT) codes for AstraZeneca's COVID-19 vaccine. The American Medical Association (AMA) today announced that the Current Procedural Terminology (CPT®) code set is being updated by the CPT Editorial Panel to include immunization and administration codes that are unique to the COVID-19 vaccine under development by AstraZeneca and University of
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Amazon, CVS Health, Thermo Fisher Scientific Form Alliance for Employer-based COVID-19 Testing

by Jasmine Pennic 12/23/2020 Leave a Comment

Amazon, CVS Health, Thermo Fisher Scientific Form Alliance for Employer-based COVID-19 Testing

What You Should Know: - Amazon, CVS Health, Thermo Fisher Scientific join forces to promote employer-based testing As part of a comprehensive COVID-19 testing strategy. - The coalition, named Workplace Employers Alliance for COVID-19 Testing (WE ACT), believes that employer-based testing programs are essential to keeping employees safe during the current public health emergency. - WE ACT aims to advance a comprehensive national testing strategy that includes clear guidance for the
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DoD Awards $2.8M to Philips & BioIntelliSense to Validate Wearable for Early COVID-19 Detection

by Jasmine Pennic 12/23/2020 Leave a Comment

DoD Awards $2.8M to Philips & BioIntelliSense to Validate Wearable for Early COVID-19 Detection

What You Should Know: - Philips and BioIntelliSense has been selected by the U.S. Army Medical Research and Development Command (USAMRDC) to receive nearly $2.8M from the U.S. Department of Defense (DoD) to validate BioIntelliSense’s FDA-cleared BioSticker device for the early detection of COVID-19 symptoms. - Working with the University of Colorado Anschutz Medical Campus, the clinical study will consist of 2,500 eligible participants with a recent, known COVID-19 exposure and/or a
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Carrot Enters Global Market for Tobacco Cessation with it’s CE Marked Breath Sensor

by Jasmine Pennic 12/22/2020 Leave a Comment

Carrot Enters Global Market for Tobacco Cessation with it’s CE Marked Breath Sensor

What You Should Know: - Digital health company Carrot has obtained CE Mark Certification for its breath sensor, marking its official entry into the global market for tobacco cessation. - Clinically proven to increase the motivation to quit, the company’s device is the first-ever FDA-cleared breath sensor for consumer use. Carrot, a Redwood City, CA-based digital health company that delivers clinically proven, behavioral science-based solutions that empower people to take control of
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42 Recently Launched COVID-19 Vaccine Management Solutions to Know

by Fred Pennic 12/18/2020 Leave a Comment

16 COVID-19 Predictions and Trends for 2021 Executive Roundup 12-Available-COVID-19-Vaccine-Management-Solutions-to-Know-In-Depth-1

An in-depth look at twelve recently released COVID-19 vaccine management solutions as COVID-19 vaccines are being distributed nationwide. 1. Microsoft Microsoft launches a COVID-19 vaccine management platform with partners Accenture and Avanade, EY, and Mazik Global to help government and healthcare customers provide fair and equitable vaccine distribution, administration, and monitoring of vaccine delivery. Microsoft Consulting Services (MCS) has deployed over 230 emergency COVID-19
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Why Some COVID-19 Testing Protocols Aren’t What You Think

by Pawel Czech, the founder of Nex.D & GeneMe 12/18/2020 Leave a Comment

Some COVID-19 Testing Protocols Aren’t What You Think

While countries around the world continue to flounder with regards to COVID-19 testing, everyone is wondering how national governments could get things so horribly wrong. It’s true that governments have acted incompetently, leaders can make poor judgment calls, and optimistic testing targets are rarely achieved. But the claims of various ambitious big pharma companies—about their ability to deliver on capacity and accuracy alike—have created a smokescreen for decision-makers, one that has
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How Hackers Are Targeting COVID-19 Vaccine Distribution Chains – Q/A

by Fred Pennic 12/16/2020 Leave a Comment

COVID-19 Vaccine Cyber Attacks

With the US and other major countries poised to begin national distribution of multiple FDA-approved COVID-19 vaccines, the cybersecurity threats to secure COVID19 vaccine distribution is imminent. Earlier this month, IBM released a report on malicious cyber actors targeting the COVID-19 cold chain—an integral part of delivering and storing a vaccine at safe temperatures. Impersonating a biomedical company, cyber actors are sending phishing and spear-phishing emails to executives and global
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Medical Device Design: 4 Ways Designers Can Create Medical Devices That Work for Everyone

by Stuart Karten, Founder/President, Karten Design 12/16/2020 Leave a Comment

Karten Design: Design Must Play a Larger Role in Healthcare

Medical device design has been going through sweeping changes over the last decade.  Ten years ago, medical device companies weren't concerned with delivering consumer-level design: Devices that are both attractive and intuitively easy to use by a wide variety of users.  Then the Affordable Care Act was passed, and adherence and healthy behavior change became a regulatory requirement.   Our firm, which has been a long-time proponent of the “consumerization” of medical
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