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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FDA| Healthcare FDA Regulation | Policy, News, Analysis, Insights - HIT Consultant
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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WellDoc Receives FDA 510(k) Clearance for Non-Prescription Version of BlueStar® Digital Therapeutic
Digital health leader WellDoc has received FDA 510(k) class II clearance for a non-prescription version of the BlueStar® digital therapeutic diabetes management platform. This news comes on the heels of two other significant recent announcements for BlueStar®: the FDA’s clearance of the wireless integration of LifeScan’s OneTouch Verio Flex® blood glucose monitoring system with BlueStar®, and plans to incorporate the American Association of Diabetes Educators’ (AADE) curriculum in the BlueStar®
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MOCACARE Unveils FDA-Approved Wireless Blood Pressure Monitor
MOCACARE, a Silicon Valley based company has launched MOCACuff, a FDA-approved wireless blood pressure monitor that fits comfortably on the wrist. Priced at $69.99, MOCACuff is the second product in the MOCACARE line that makes it easy to incorporate blood pressure monitoring into your everyday routine and receive instant, actionable insights to improve your health.MOCACARE first product, MOCAheart device uses thumb scans to measure heart rate, blood oxygen levels, and pulse wave velocity - a
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AirStrip Granted FDA 510(k) Clearance, Patent for AirStrip ONE App
AirStrip announced it has received FDA 510(k) clearance to a web client for the AirStrip ONE® mobile interoperability platform and app that can be run on desktops and laptops using Internet Explorer and Google Chrome. AirStrip ONE® provides a single, data- and vendor-agnostic platform that connects clinicians with the right information at the right time, via the most convenient device at hand.The company also recently received a U.S. patent for new functionality: ECG waveform 'visual calipers'
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FDA, Flatiron Health Team Up for Cancer Research Initiative
Flatiron Health and the FDA have teamed up on a new research collaboration agreement to determine how real-world evidence derived from de-identified, HIPAA-compliant patient data captured outside of clinical trials can provide new insights into the safety and effectiveness of emerging anti-cancer therapies such as immunotherapeutic agents.Research Initiative DetailsAs part of this research initiative, Flatiron Health and the FDA are collaborating on a project to investigate the use of
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Senate Health Commitee Confirms New FDA Head Dr. Robert Califf
Senate health committee today confirmed President Obama's nominee Dr. Robert Califf to be the new commissioner of the Food and Drug Administration (FDA) in a vote of 89 to 4. The vote comes after over a month of opposition from Senate over the FDA's response to prescription painkiller abuse. Dr. Califf, a cardiologist and clinical researcher from Duke University, has been a consultant to drug companies was meet with resistance from Democrats who felt his ties to drug companies would be a
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20 Promising Canadian Digital Health Companies to Watch
“A company’s odds of success are better the closer they can get to their market,” argues Stephen Hurwitz, a thought leader in the Canadian venture capital industry, recognizing that the proximity to a VC-tech hub can help the success rate of Canadian startups. A socialized healthcare system, Canada’s market is fragmented by province and type of care – most primary and emergency care is free for residents whereas specialty care, prescription drugs, long-term and in-home care amongst others,
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4 Mobile Health Challenges for Medical Device & Diagnostic Firms
Bernhard Kappe, Founder & CEO of Pathfinder Software outlines four key mobile health challenges for medical device & diagnostic firms.
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