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Medical Devices | FDA | News, Analysis, Insights - HIT Consultant

Medigate and Cerner Partner to Advance Medical Device Security

by Fred Pennic 12/19/2019 Leave a Comment

3 Major Problems With the Medical Device and Wearables Market in 2019

- Medical device security and management solution Medigate is teaming up with Cerner to make it easier for healthcare organizations to establish and maintain strong network security, manage medical device security risks, and keep operations intact.- The average hospital room has nearly 15 to 20 devices that can connect to the cloud and apps. This is exactly why device security and healthcare technology must work together to ensure the protection of the most sensitive and valuable data.Medigate,
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VA to Deploy Podimetrics SmartMat Regionally to Prevent Diabetic Foot Ulcers

by Fred Pennic 11/18/2019 Leave a Comment

VA to Deploy Podimetrics SmartMat Regionally to Prevent Diabetic Foot Ulcers

- VA recently announced they will be offering a care management solution designed to detect and prevent one of the costliest and most complicated diabetes-related issues, diabetic foot ulcers, to a wider group of veterans in need. - The solution, Podimetrics' SmartMat, is currently in 15 VAs and starting Dec. 1, more VAs will begin offering the easy-to-use mat to its patients.- Last year alone, the VA treated nearly 75,000 cases of DFU and spends more than $3 billion per year on the issue,
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FDA Clears AI-Powered EchoGo Core for Early Detection of Cardiovascular Disease

by Fred Pennic 11/15/2019 Leave a Comment

FDA Clears AI-Powered EchoGo Core for Early Detection of Cardiovascular Disease

- Ultromics has just become one of the first companies to have 510(k) FDA clearance for an AI medical device. - EchoGo will now be available for clinicians in the UK and US to use to help them identify cardiovascular disease earlier. - EchoGo automates cardiac measurements and is the first AI application to measure cardiac strain, improving patient care and outcomes.Ultromics, the UK-based health technology firm at the forefront of applying artificial intelligence to echocardiography has
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Medtronic Launches FDA-Approved Deep Brain Stimulation Device in U.S.

by Fred Pennic 10/31/2019 Leave a Comment

Medtronic Launches FDA-Approved Deep Brain Stimulation Device in U.S.

- Samsung and Medtronic unveils new state of the art FDA-approved Deep Brain Stimulation (DBS) device that uses a surgically implanted medical stimulator to deliver electric pulses directly to the brain.- Rather than using a bulky medical device, the Medtronic DBS solution allows patients to manage their therapy more discreetly and actually can reduce the need for regular doctor visits through more streamlined coordination directly with clinicians.Medtronic announced the U.S. launch of its
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Kaiser Associates’ Healthcare Practice Is Now Kx Advisors

by Jasmine Pennic 10/30/2019 Leave a Comment

Kaiser Associates' Healthcare Practice Is Now Kx Advisors

- Kaiser Associates launches healthcare strategy consultancy Kx Advisors to help clients reach their critical growth goals. Kaiser Associates announce the launch of Kx Advisors, a healthcare strategy consultancy dedicated to helping achieve critical business growth goals in partnership with its clients in Pharma, Biotech, Medical Device, and Health IT. The new consultancy is already operating under the Kx Advisors name at the Washington D.C., London, and Hong Kong offices. For more than 30
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HIT Governance: 7 Key Metrics For Your Quarterly Report Card

by Gerry Blass is President and CEO of ComplyAssistant 10/29/2019 Leave a Comment

HIT Governance: 7 Key Metrics for Your Quarterly Report Card

Healthcare organizations use data to support decision-making for nearly every area of operations. But what about your security and compliance strategy? What metrics are the most valuable to determine how your organization should allocate funding for health IT projects related to governance, risk, and compliance? Top Seven Metrics to Gather For A Quarterly Report Card With an ocean of data at your fingertips, it’s best to determine the metrics that will best support your strategy, and any budget
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ConvergeHEALTH by Deloitte Launches New Digital Health Ecosystem Platforms

by Jasmine Pennic 10/28/2019 Leave a Comment

ConvergeHEALTH by Deloitte Launches New Digital Health Ecosystem Platforms

- ConvergeHEALTH MyPATH for Health and MyPATH for Connected Care help enhance the patient experience, improve adherence and generate a rich, longitudinal, real-world data set for insights.Today at HLTH 2019, ConvergeHEALTH by Deloitte announced the launch of a robust platform for the healthcare ecosystem that supports two critically important patient journeys. MyPATH for Health and MyPATH for Connected Care work together to connect and support patients and their care teams across the patient
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Cognoa Launches Pivotal Study of Diagnostic Aid for Autism

by Fred Pennic 10/25/2019 Leave a Comment

Cognoa Awarded FDA Breakthrough Designations for Diagnostic and Digital Therapeutic Devices for Autism

- Cognoa launches a pivotal study to demonstrate the effectiveness of its diagnostic aid for autism spectrum disorder (ASD).- The results of this pivotal study will be the basis for the submission to the FDA in 2020.  - The Cognoa digital diagnostic aid has the potential to become the first cleared medical device to help diagnose autism intended to be used by pediatricians and primary care physicians.Cognoa, a Palo Alto, CA-based pediatric behavioral health company developing digital medicines,
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Sleep Wearable Beddr Launches First Sleep Health Solution for Employers

by Fred Pennic 10/23/2019 Leave a Comment

Sleep Wearable Beddr Launches First Sleep Health Solution for Employers

- Beddr launches first holistic sleep wellness program for employers that leverages clinical-grade data from Beddr’s FDA cleared wearable.- Beddr expands upon its FDA-listed sleep wearable with improved data and insights, expert-led sleep coaching and sleep physician telemedicine network.Beddr, a pioneer in precision sleep health launched an industry-first comprehensive solution for employers focused on helping employees identify and treat the root causes of chronic sleep issues. The program
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XLerateHealth Awarded $1.7M Grants to Fuel Healthcare Innovation in Under-Resourced States

by Fred Pennic 10/22/2019 Leave a Comment

XLerateHealth Accelerator Unveils Its Sixth Class of 10 Digital Health Startups

- XLerateHealth (XLH) has been awarded a total of $1.7M in grants to continue building the XLerator Network and support academic healthcare innovation across the Southeast. - The continuation of the grant secures a second year of funding for XLH and its partners to build on foundational assessment and planning work completed in year one.XLerateHealth (XLH), a Louisville, KY-based healthcare accelerator has been awarded grants totaling $1.7M to continue building the XLerator Network and support
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