What You Should Know:
- CLEW is awarded FDA Emergency Use Authorization (EUA)
for its predictive analytics platform in support of COVID-19 patients.
- CLEW is the only device authorized by the FDA to
provide early identification of patients who are likely to experience
respiratory failure of hemodynamic instability—both significant complications
associated with COVID-19.
- CLEW is already implemented in coronavirus units in two
Israeli hospitals, and being tested by several US
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FDA| Healthcare FDA Regulation | Policy, News, Analysis, Insights - HIT Consultant
5 Reasons Why Providers Need Electronic Support for Glycemic Management
It’s no secret hyperglycemia and hypoglycemia are associated with adverse outcomes in hospitalized patients. We’ve known for many years that hyperglycemia is widespread in the hospital, causes immune dysfunction, higher rates of infection, a longer length of hospital stay, complications, and even death.
Insulin has been the most effective therapy for hyperglycemia since it was first created almost 100 years ago, but it can also be dangerous if not managed properly. In fact, nearly 50% of all
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Augmedics Lands $15M for FDA-Cleared Augmented Reality Guidance System for Surgery
What You Should Know:
- Augmented reality surgical image guidance startup Augmedics
raises $15M in Series B funding led by its U.S. staff in an effort to
secure and successfully launch the company as venture capital (VC) all but
evaporated during the COVID-19 pandemic.
- The xvision system, the first augmented reality
guidance system for surgery, allows surgeons to see the patient’s anatomy
through skin and tissue as if they have “x-ray vision,” and to accurately guide
instruments and
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Redox, Curative Partner to Connect COVID-19 Test Results to Public Health Depts.
What You Should Know:
- Curative and Redox have found a way to easily send COVID-19 test results to state officials for reporting, contact tracing programs, and to inform policies as regions move through phases for re-opening the economy.
- Since formalizing the partnership in May, the duo has kicked off projects with 24 states, with two, Illinois and Delaware, now fully live.
- In this novel use case, Curative uses the Redox API to allow for a secure, efficient flow of data between
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FDA Approves Cue Health’s Point-of-Care COVID-19 Test Using Nasal Swabs
What You Should Know:
- The Food and Drug Administration (FDA) has awarded Cue Health Emergency Use Authorization (EUA) for its rapid, portable, molecular point of care COVID-19 test.
- The company recently raised $100M in Series C funding from Menlo Park-based Decheng Capital, Foresite Capital, Madrone Capital Partners, Johnson & Johnson Innovation – JJDC, Inc., ACME Capital, and other investment firms.
Cue Health Inc.
(“Cue”), a healthcare
technology company,
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Cue Health Lands $100M to Scale Rapid, Portable, Point-of-Care COVID-19 Test
What You Should Know:
- Cue Health raises $100M to commercialize its portable, molecular diagnostic test capable of detecting SARS-CoV-2, the virus that causes COVID-19, in less than 25 minutes using a simple nasal swab.
- The test is part of the Cue Health Monitoring System, which is designed to be a portable device that can perform a molecular test and connect patients to a mobile health platform that features interventional components such as telemedicine
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Consumer Genetic Tests Accelerate Precision Medicine for Some Providers
Direct-to-consumer (DTC) genetic tests have been on the scene for some time now. The Federal Drug Administration (FDA) approved the first DTC test on three specific BRCA1/BRCA2 breast cancer gene mutations more than two years ago. Six months after that, the agency similarly green-lighted a DTC pharmacogenomic (PGx) test to examine 33 variants for eight different genes that indicate how effectively patients metabolize specific medications.
Like many such advances, availability of DTC tests is
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UCLA Health’s COVID-19 Swab Shortage Solved With 3D-Printed Swabs
What You Should Know:
- With COVID-19 numbers rising in California, an innovative project has solved UCLA Health's testing swabs shortage with 3D-printed swabs.
- In just over a month, and after conducting rigorous clinical testing of several 3D-printed swab prototypes on patients with COVID-19, UCLA Health was granted permission from the Food and Drug Administration to use the most promising design.
An innovative effort launched in April and led by a fellow in the UCLA
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COVID-19 Clinical Trials: How AI-Based Chatbots Can Provide Pandemic-Level Execution
More than 500 new COVID-19 related clinical trials have been registered as of the end of April. The race to find a COVID-19 vaccine is on and the public spotlight is on clinical trials. Strangely named drugs such as Hydroxychloroquine and Remdesivir have become household names and are featured and debated regularly on the 24-hour news channels.
The pressure to find a cure is intense. The locked-down world does not want to hear that at best, we may find a vaccine sometime in 2021. What
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Welldoc Awarded 8th FDA Clearance for Bluestar Medical Device for Diabetes
What You Should Know:
Marks 8th FDA clearance for BlueStar, the only
reimbursable software as a medical device for diabetes that integrates with all
of a patient's existing devices.
Welldoc, revolutionizing digital health with the first FDA-cleared Software as a Medical Device (SaMD) for diabetes, announced today that the U.S. Food and Drug Administration (FDA) has cleared an additional feature for the digital health product BlueStar Rx which supports individuals using long-acting
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