What You Should Know:
- The FDA granted Emergency Use Authorization to Eko for an ECG-based algorithm that screens for low ejection fraction, as part of an assessment of cardiac complications and co-morbidities associated with COVID-19.
- This ECG-based deep learning algorithm, developed on a large clinical dataset in collaboration with the Mayo Clinic, can help efficiently identify signs of possible heart failure in patients.
Eko, a digital health
company building
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FDA| Healthcare FDA Regulation | Policy, News, Analysis, Insights - HIT Consultant
FDA Expedites Clearance for AI Ultrasound Solution to Fight COVID-19
What You Should Know:
- FDA expedites clearance of Caption Health’s AI-powered ultrasound solution to aid frontline healthcare workers in the fight against COVID-19 pandemic.
- Caption Health’s AI-guided imaging supports the assessment of cardiac function and decreases personnel exposure to novel coronavirus.
In response to the growing body of evidence demonstrating
the impact of COVID-19
on the heart, the U.S. Food and Drug Administration (FDA) has expedited
clearance of an update
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Stanford Children’s Health Resumes Procedures Delayed by COVID-19
What You Should Know:
- Stanford Children’s Health announced they are ramping up services again six weeks after postponing non-emergent medical procedures due to the state-mandated suspension.
- The health system will continue ongoing safety precautions including robust PPE standards; widespread access to COVID-19 and serology testing for all employees; testing all hospital patients; as well as using telehealth tools to reduce in-person visits whenever possible, among many other actions
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Measures Adopted by Public Health Agencies to Mitigate the Consequences of COVID-19
The number of people infected by COVID-19 worldwide is quickly moving toward 2 million and almost 33% of them are from the U.S. The circumstance is past dreary and administrative bodies in the U.S. are acting rapidly to contain the harm coming about because of the spread of this novel infection.
Starting with the entry restrictions, federal agencies and healthcare regulatory bodies have executed a few measures to ensure the wellbeing and interests of healthcare professionals, program
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Shoring Up the Healthcare Supply Chain: 4 Lessons From The COVID-19 Pandemic
In December 2019, the Assistant Secretary for Preparedness and Response told a House committee that “supply chain issues were among the most significant challenges to preparing for an influenza pandemic as well as other infectious diseases.” A few months later, healthcare systems across the country and around the world are face-to-face with that harsh reality, as many of the largest healthcare suppliers are unable to fully meet the growing global demand for personal protective equipment
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AiCure Launches Platform to Remotely Capture Digital Biomarkers in Clinical Trials
What You Should Know:
- AiCure launches digital biomarker platform to remotely detect subtle changes in a patient's condition, leverages computer vision and AI to gather and analyze visual and auditory cues directly through the patient's smartphone camera.
- AiCure appoints Ed Ikeguchi, M.D. as its Chief Executive Officer (CEO) to advance AiCure's commitment to improving holistic health through an understanding of the science behind human responses to illness and treatment.
AiCure,
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HeartVista Raises $8.65M to Expand One Click, AI-Guided MRI Platform
What You Should Know:
HeartVista, a pioneer in AI-assisted MRI solutions raises
$8.65M in Series A funding led by Khosla Ventures, Jeff Rothschild, Leslie
Ventures, Open Field Capital, and additional investors.
The startup plans to use the funding to fuel new
musculoskeletal and neural products, expand internationally, and deepen
strategic alliances with the world’s leading cardiology centers.
HeartVista,
a pioneer in AI-assisted MRI solutions, today announced the closing of a
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In-Depth: 32 FDA-Approved COVID-19 Testing Kits
What You Should Know:
- In-depth look list of FDA-approved COVID-19 test kits
The U.S. Food and Drug Administration (FDA) offers emergency use authorizations (EUAs) for unapproved products or new uses for approved items in urgent situations where no suitable alternatives exist. Dozens of companies have sought and received EUAs for their testing kits that screen for SARS-CoV-2 — more commonly referred to as COVID-19 or the novel coronavirus.
The FDA makes a
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XRHealth Lands $7M to Expand Telehealth VR/AR Platform
What You Should Know:
XRHealth raises $7M in funding to expand its telehatlh virtual reality (VR)/augmented reality (AR) platform for clinicians and patients.
XRHealth is the first certified Extended Reality medical
company in the world; their Medical Applications are FDA & CE
Registered.
XRHealth created the first virtual reality telehealth
clinic in the world that is currently certified in 17 states.
XRHealth, formerly known as VRHealth a provider of extended
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FDA Approves COVID-19 Oral Fluid Test for Use Nationwide
What You Should Know:
- The FDA today authorized testing startup Curative Inc.’s COVID-19 oral fluid test under Emergency Use Authorized (EUA) guidelines.
- Curative’s fast, easy-to-use, accurate, and rapidly scalable test does not create exposure risk for healthcare workers during sample collection and requires less PPE.
- Already in use by City and County of Los Angeles and the City of Long Beach, Curative has helped more than 53K people get tested.
Today, COVID-19
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