What You Should Know:
- physIQ has been selected by the National Institute of Health (NIH) to develop an innovative AI-based COVID-19 digital biomarker solution to address the COVID-19 pandemic.
- Early detection of COVID-19 decompensation in patients
is complicated by infrequent and non-specific clinical data. The first-in-kind
tool will collect and analyzes continuous physiologic data could provide early
clinical indicators of COVID-19 decompensation.
The National Cancer
Institute
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FDA| Healthcare FDA Regulation | Policy, News, Analysis, Insights - HIT Consultant
Is Glucometrics The Missing Data in the Fight Against COVID-19?
Glucometrics – the system-wide analysis of inpatient glucose data – should be of fundamental interest for hospital administrators striving to improve the outcomes of their patients.
Why is this data so important? Proper glycemic control has been linked to improved outcomes and decreased length of stay time and time again across a myriad of conditions – whether it’s someone recuperating from a heart attack, battling pneumonia, or recovering from surgery.
The U.S. health system lacks
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Clarius Unveils Ultra-High Frequency Handheld Ultrasound Scanner
What You Should Know:
- A pioneer in high definition ultrasound
miniaturization, Clarius is announcing the new high-frequency handheld
ultrasound scanner Clarius L20 HD featuring the highest definition wireless
imaging for superficial applications.
- Designed to provide extremely high image quality in the near field (skin line to 4cm), the Clarius L20 HD is ideal for a variety of clinical settings including MSK, rheumatology, podiatry, plastic surgery, microsurgery, pediatric
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PreferredOne Becomes First Health Plan to Cover Prescription Digital Therapeutics
What You Should Know:
- PreferredOne teams with Pear to provide its members
with covered access to two prescription digital therapeutics (PDTs) for the
treatment of substance use disorder (SUD) and opioid use disorder (OUD)
- PDTs are a new therapeutic class that uses software to
directly treat disease. Like traditional medicines, PDTs are tested in
randomized controlled trials demonstrating safety and effectiveness, evaluated
and authorized by regulators like FDA, and used under the
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RADLogics Secures FDA Clearance for AI-Powered Chest X-Ray App for Triage & Prioritization
What You Should Know:
- RADLogics today announced that it has secured
510(k) clearance from the FDA for the company’s novel AI-Powered chest X-ray pneumothorax application,
which identifies and prioritizes chest X-ray scans that appear
to contain a pneumothorax, a collapsed lung, for urgent radiologist review.
- RADLogics’ FDA cleared CT and X-ray solutions
– including this application – are
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FDA Launches Digital Health Center of Excellence: 5 Things to Know
What You Should Know:
- FDA launches the Digital Health Center of Excellence within
the Center for Devices and Radiological Health (CDRH) focused on mobile health
devices, Software as a Medical Device (SaMD), wearables when used as a medical
device, and technologies used to study medical products.
- The Digital Health Center of Excellence is part of an effort to modernize digital health policies and regulatory approaches and provide efficient access to highly specialized expertise,
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XRHealth Secures Patent to Incorporate Apple Watch into VR/AR Therapy
What You Should Know:
- XRHealth has just received a patent for its approach to
incorporate biofeedback from devices such as an Apple watch into its remote
healthcare therapy platform that utilizes virtual/artificial reality (VR/AR).
- XRHealth plans to incorporate their VR/AR therapy with the Apple Watch, specifically since the watch has advanced features including a medical-grade, FDA-cleared electrocardiogram (EKG) that measures heartbeat.
XRHealth, the
leader in extended
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Fitbit Awarded Regulatory Clearance in U.S. and Europe for ECG App to Identify AFib
What You Should Know:
- Fitbit has received 510(k) clearance from the
FDA, as well as CE marking in the European Union, for its ECG
app to assess heart rhythm for atrial fibrillation. The Fitbit ECG App is a
simple way people can take an on-the-spot reading of their heart rhythm at any
time, including whenever they notice any unusual cardiac symptoms.
- Fitbit Sense is the company’s first device compatible
with an ECG app that enables users to take a spot
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Intel, Samsung Collaborate on AI-Powered Fetal Ultrasound Smart Workflow
What You Should Know:
- Samsung Medison and Intel collaborate on AI-powered new
smart workflow solutions to improve obstetric measurements that contribute to
maternal and fetal safety.
- BiometryAssist automates and standardizes fetal
measurements in approximately 85 milliseconds with a single click, providing
over 97% accuracy.
- BiometryAssist and LaborAssist are already in use in 80
countries, including the United States, Korea, Italy, France, Brazil and
Russia. The solutions
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How the Simple Telehealth Visit Will Revolutionize Care Delivery and Disease Management
The impact of COVID-19 on the healthcare industry’s ability to innovate has been stunning. We have seen FDA emergency authorizations and relaxed regulatory guidelines enable the development of radical new ventilator ideas, accelerated timelines for vaccine development, and an extraordinary transition to telehealth services. Many of these actions were a response to the exposure of weak spots in our healthcare system, but even as those weaknesses have been shored up (in large part due to public
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