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Medical Devices | Policy & Regulation News, Analysis, Insights - HIT Consultant

HHS Launches $1.5M Second Phase of KidneyX Prize Competition to Redesign Dialysis

by Fred Pennic 11/20/2019 Leave a Comment

HHS Launches $1.5M Second Phase of KidneyX Prize Competition to Redesign Dialysis

- KidneyX launches the $1.5 million second phase of the Redesign Dialysis prize competition.- Redesign Dialysis Phase 2 seeks prototype solutions or components of solutions, that can replicate normal kidney functions or improve dialysis access.- The competition calls on researchers, innovators, patients, and investors with expertise in nephrology, biotechnology, bioengineering, and medical devices to submit solutions.The U.S. Department of Health and Human Services (HHS) and the American Society
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Philips Debuts AI-Driven Clinical Solution for Aiding Cognitive Assessment in the U.S.

by Fred Pennic 11/12/2019 Leave a Comment

Philips Debuts AI-Driven Clinical Solution for Aiding Cognitive Assessment in the U.S.

- Philips IntelliSpace Cognition provides U.S. healthcare professionals with a powerful aid for assessing cognitive impairments due to neurological conditions. - Philips has invested in collecting insights from both neurologists and neuropsychologists in order to design IntelliSpace Cognition in an iterative manner and ensure it fits into the majority of existing workflows. - IntelliSpace Cognition will initially be commercially available only in the U.S. Philips, a global leader in
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Japanese Startup AI Medical Secures FDA Approval for Real-Time Endoscopic AI Platform

by Fred Pennic 11/11/2019 Leave a Comment

Japanese Startup AI Medical Secures FDA Approval for Real-Time Endoscopic AI Platform

Key Highlights- AI Medical Service, a Toyoko, Japan-based endoscopic artificial intelligence provider announces it has been granted Breakthrough Device Designation by the FDA. - FDA Breakthrough Device Designation expedites the traditional development, assessment, and review process, and enables medical professionals to get access to new developments quickly.- Designation will also enable the company to launch its project in the U.S. and expand to other markets across the world.AI Medical
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Privileged Only: Is Digital Health Tech A Solution for Elites?

by Anish Sebastian, Co-founder and CEO, Babyscripts 11/11/2019 Leave a Comment

Bullshit Metrics: Is Patient Engagement Real?

Healthcare disruptors are betting the farm on digital health technology, and they have the funds to validate their enthusiasm. Investments in digital health startups came in at a staggering $8.1B at the end of 2018, marking an increase of 42% from 2017. While investments are slowly beginning to level out in 2019, analysts see this as a sign that the industry is maturing; not, as some thought, as a signal of pending collapse.   Health tech has been touted as the cure-all for financial
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Q/A: Life Image CEO Matthew Michela Talks Data Sharing Challenges in Breast Imaging

by Erica Garvin 10/31/2019 Leave a Comment

Life Image CEO Talks Matthew Michela Creating Easier Access to Breast Imaging Data

- President and CEO Matthew Michela talk about how Life Image is creating easier access to breast imaging data while also solving some of data sharing’s biggest snags. Interoperability—it’s the long-awaited result that evolving HIT promised to bring with it, and yet, it still gets left behind. Disparate data is not a problem exclusive to one data type or innovation; breast imaging, for example, has created some of the toughest challenges. However, there is now an app for that. Life Image,
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Validic, Trapollo Partner to Offer Hardware & Software Services Supporting Remote Patient Monitoring

by Fred Pennic 10/31/2019 Leave a Comment

Validic, Trapollo Partner to Offer Hardware & Software Services Supporting Remote Patient Monitoring

- Validic and Trapollo are teaming up to offer comprehensive hardware and software services supporting remote patient monitoring (RPM). - The collaboration combines Validic's strengths in data connectivity and analytics with Trapollo's strengths in hardware provisioning and logistics.Validic, a market leader in solutions for personal health data, and Trapollo, a Cox Business company and a leading provider of managed services for telehealth and remote health monitoring, announced today a
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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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Data: The Foundation For Collaborative Leadership To Deliver High-Value Care

by Karen Conway, Vice President, GHX and Li Ern Chen, MD MSCS 10/23/2019 Leave a Comment

Data: The Foundation For Collaborative Leadership To Deliver High-Value Care

The move to a healthcare system that rewards the value delivered to patients vs. the volume of services performed is no easy task. Healthcare providers, including hospitals and physicians, face decreasing reimbursements as both commercial and government payors implement new payment models designed to more closely align the activities of various organizations and practitioners involved in patient care. Better coordination has been found to both improve the quality and lower the cost of care,
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Jumping to Lightspeed – Consolidating Patient Monitoring Devices

by Guy Meger, CTO and VP of Research & Development and Israel GM at EarlySense 10/17/2019 Leave a Comment

Jumping to Lightspeed - Consolidating Patient Monitoring Devices

In the early summer of 2005, Star Wars Episode III – Revenge of the Sith premiered worldwide. Diehard fans flocked to the theaters to see Anakin Skywalker embrace the dark side of the force, battle Obi Wan Kinobi and transform into the infamous Darth Vader. While audiences were enthralled by vivid battle scenes and cool effects, I was intrigued by a less popular scene, where Padmea, mother of Luke and Leia Skywalker, is examined and cared for in an out-of-this-universe hospital room. Padmea
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HIMSS Report: Current State of Japan’s Digital Health Economy

by Jasmine Pennic 10/01/2019 Leave a Comment

- New HIMSS report reveals the current state of Japan’s digital health economy in the era of aging societies. - Japan and the UK share some common traits in healthcare and society that has resulted in each country’s healthcare sector experiencing rising costs and a dwindling human resource pool.HIMSS announced that it has published a report titled “Capitalising on Japan’s Digital Healthcare Economy during this Era of Ageing Societies.” Written by Professor Sudhesh Kumar, Dean of Warwick Medical
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