Big News, But Just The Beginning
These days, big news stories in healthcare are just as likely to come from large technology companies as from major healthcare institutions. Case in point: In early 2018, Amazon created a huge stir in the industry early by announcing a venture with JPMorgan and Berkshire Hathaway that promised to go after the “hungry tapeworm” that is the cost of healthcare in the
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FDA| Healthcare FDA Regulation | Policy, News, Analysis, Insights - HIT Consultant
Medical Informatics Corp. Raises $11.9M for FDA-Cleared Patient Monitoring and Predictive Analytics Platform
Medical Informatics Corp. (MIC), a Houston, TX-based provider of an FDA-cleared patient monitoring and predictive analytics platform has raised $11.9M in Series A funding led by Data Collective Venture Capital (DCVC) with significant participation from Intel Capital and the Texas Medical Center (TMC) Venture Fund.The Inaccurate State of Today’s Predictive Analytics in Hospital SystemsHospital systems across the country are searching for ways to use machine learning and AI to get ahead of
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UM Spinout Fifth Eye Lands $11.5M for Early Warning Patient Deterioration System for Hospitals
Fifth Eye, a medical device software spinoff from the University of Michigan building clinical early warning patient deterioration system for hospitals has raised $11.5 million in Series A funding led by Arboretum Ventures and Cultivation Capital. Other participants in the round include were MINTS, the direct investing arm of the University of Michigan’s endowment, along with additional capital from previous investors Invest Michigan and 35 private angel investors.Why Clinicians Need A Better
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HIMSS19 Day 2 Announcements & Summary
Accenture: Millenials & Gen Z Are Shifting to Virtual, Retail, Clinic, Digital CareMillennial and Gen Z consumers in the U.S. are rapidly adopting non-traditional care models, such as retail clinics, virtual and digital services, according to results of an Accenture survey of 2,000 consumers.Key findings of the survey study include:- When considering traditional in-person care, millennials (ages 22 to 38 in 2019) were two to three times more likely than baby boomers (ages 55 to 73) to be
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Why the FDA Is Doing an Overhaul of the Medical Device Approval Process
Since 1976, the U.S. Food and Drug Administration (FDA) has allowed manufacturers to apply for an accelerated pathway to bringing their devices to the market. It's called the 501(k) Premarket Notification. In short, if a new device gets proved safe and effective to a device that's already available, the new device can get cleared because it's considered substantially similar to the older one. The FDA also allows for the first-cleared device (also known as the predicate) to be another product
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IDx and Topcon Join Forces to Scale AI-based Diagnostic Platform in the U.S. Market
IDx, an AI diagnostics company, and Topcon, one of the world’s leading ophthalmic device manufacturers, have signed an exclusivity agreement that will allow the companies to scale delivery of AI-based diagnostic solutions in the U.S. market. As part of the agreement, is granted exclusive rights to IDx-DR system, an autonomous AI system that instantly detects diabetic retinopathy in fundus images, exclusively with Topcon NW400, an easy to use, robotic fundus camera. IDx-DR is an FDA-cleared
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Protecting Medical Device Security in the Age of Ransomware
From medication pumps to pacemakers, people depend on lifesaving devices to live their healthiest possible lives and manage chronic ailments. Many of those patients likely hear about cybercriminals orchestrating massive data breaches, and might get concerned about one of those incidents compromising their information.However, they probably haven’t considered the hackers might target the devices in their bodies or the ones they otherwise use for better well-being.Hospitals Must Pay Attention to
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DreaMed Diabetes Granted FDA Approval for Personalized Diabetes Decision Support Solution
DreaMed Diabetes, an Israeli-based developer of personalized diabetes management solutions, today announced that the U.S Food and Drug Administration (FDA) has granted a De Novo request for DreaMed Advisor Pro, an artificial intelligence (AI)-based diabetes treatment decision support software. Advisor Pro is indicated to assist healthcare providers in the management of people with type 1 diabetes who use insulin pumps and continuous glucose monitoring (CGM).The announcement marks the second
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OpenEMR Security Vulnerability Could Expose Medical Records Impacting 90M Patients
Editor's Note: Sven Krewitt is the Senior Vulnerability Researcher for Risk Based Security, a detailed information and analysis on data breaches and vulnerability intelligence. Krewitt brings 11 years of experience as a security specialist and vulnerability researcher. He has previously worked as a Senior Security Specialist focusing on vulnerability analysis, quality assurance, and training of new employees.The first known medical vulnerability currently on record is from June 1985 and was in a
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Kinsa Closes $17M in Financing to Develop Additional Digital Health Products
Kinsa, the company behind the world’s first FDA-cleared smartphone-connected thermometer has closed $17 million in additional financing from GSR Ventures, Kleiner Perkins Caufield Byers, FirstMark Capital and others. The funds will be used to develop additional smart products and services to further Kinsa’s mission to better track and stop the spread of illness. Features such as wellness tips, real-time fever guidance, medication reminders, connection to physicians, local health information and
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