On Friday, the leaders of the Senate and House health committees released a discussion draft of bipartisan legislation reauthorizing the Food and Drug Administration user fee agreements. The Food and Drug Administration (FDA) Reauthorization Act of 2017 renews FDA's authority to collect user fees from the makers of prescription brand drugs, medical devices, generic drugs and biosimilars, and several vital programs at the FDA.The 2012 prescription drug user fee amendments (PDUFA), medical device
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Digital Health | News, Analysis, Insights - HIT Consultant
Report: Apple Developing Sensors to Monitor Blood Sugar for Apple Watch Integration
Apple has hired a team of biomedical engineers to develop sensors that can noninvasively and continuously monitor blood sugar levels to better treat diabetes, according to CNBC. The initiative was initially envisioned by Steve Jobs before his death and has been in development for at least the past five years, with about 30 people working on the project and reports to Johny Srouji, Apple's senior vice president of hardware technologies. Some of the engineers have been working with the Apple team
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Sansoro Health Raises $5.2M For Real-Time Data Exchange Between EMRs & Digital Health Apps
Sansoro Health, a Minneapolis MN-based startup that makes it easy to exchange real-time health care data between digital health applications and EMRs led by Bain Capital Ventures. The digital health startup plans to use the funding to expand sales, marketing and operations to accelerate transforming health care IT ecosystems through real-time digital health interoperability.Among U.S. hospital system chief information officers, 62% identify interoperability as their most important
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Philips Awarded FDA Clearance for Digital Pathology Solution for Primary Diagnostic Use
Today, Philips announced it has received regulatory clearance from the FDA (via De Novo classification) for its IntelliSite Pathology Solution, marking a significant leap forward for the pathology services industry in the U.S. De novo classification is the regulatory pathway for marketing clearance for novel, low- to moderate-risk medical devices that are the first of their kindAs the first and only digital pathology system to be approved for primary diagnostic use in the country, today’s news
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NextGen Healthcare to Acquire Mobile EHR Engagement Platform Entrada for $34M
NextGen Healthcare Information Systems, LLC, a wholly owned subsidiary of Quality Systems, Inc. has acquired Entrada, Inc., a Brentwood, TN-based mobile engagement platform for EHRs for $34 million in cash. The acquisition is expected to close upon completion. Entrada reported revenue of approximately $12 million and had a loss of approximately $2 million in 2016.Founded in 2005, Entrada’s mobile app platform integrates with multiple clinical platforms and all major EHRs. Because of its
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Biotricity Files for Final FDA 510(k) Clearance for Remote Cardiac Monitoring Wearable
biotricity, a Redwood City, CA-based healthcare technology company has filed for a second and final 510(k) for the hardware portion of its remote cardiac monitoring software and device, Bioflux solution with the U.S. Food and Drug Administration (FDA). The announcement follows a previous milestone where Biotricity received FDA approval for the software portion of its remote cardiac monitoring wearable.This 510(k) is the final regulatory requirement needed for Biotricity to bring its Bioflux
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Litmus Health Unveils Free Version of Data Science Platform for Academic Researchers
Litmus Health, a clinical data science platform focused on health-related quality of life has released a free version of its data science platform for academic researchers running trials and studies. With Litmus Free, researchers gain access to modern tools for running data-driven clinical trials. Imagine if every academic institution had a modern EDC and the ability to collect patient data from the point of experience. Litmus Free is their opportunity to shift budget and resources from the
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HealthPartners Partners With Welltok to Deliver Personalized Health Experience for Members
HealthPartners and Welltok has announced a partnership that will allow HealthPartners to deliver a more personalized health experience for its members. The new health personalization platform will allow participants to create customized health goals (for example, eating less salt or exercising more), and then get rewarded for meeting those goals.The technology will also suggest programs and resources that address emotional and financial health. It will also be linked to their individual health
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Highmark Partners With Best Doctors to Provide Virtual Second Opinions for Members
Highmark, the nation's fourth-largest Blue Cross and Blue Shield-affiliated organization is partnering with Best Doctors to provide virtual expert second opinions for Highmark members and their physicians dealing with rare or complex medical conditions. Best Doctors provides access to more than 53,000 of the world’s brightest minds in over 450 medical specialties, without the need for patients to travel far from home. Data from Best Doctors show that consultation with its experts results in
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SV Life Sciences Rebrands As SV Health Investors, Closes $400M Fund
Boston-based healthcare and life sciences venture capital and growth equity firm SV Life Sciences has changed its name to SV Health Investors and has closed its sixth flagship fund target of $400 million. SV Health Investors' venture partner program focuses on leveraging experienced healthcare entrepreneur to serve as hands-on advisors and directors for portfolio companies. This approach contributes to SV's appeal to both potential investors and entrepreneurs. The new multi-sector focus fund
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