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FDA| Healthcare FDA Regulation | Policy, News, Analysis, Insights - HIT Consultant

First Databank Clinician Addresses COVID-19 Vaccine Skepticism – Q/A

by Fred Pennic 03/03/2021

As the Biden administration ramps up its efforts to increase the access of COVID-19 vaccines to more Americans, there are a large number of Americans who are skeptical about of the COVID-19 vaccine. About 1 in 3 Americans stated they definitely or probably won’t get the COVID-19 vaccine, according to a recent poll from the Associated Press-NORC Center for Public Affairs Research. The poll reveals while 67% of Americans plan to get vaccinated or have already done so, 15% are certain they
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Kroger Health to Offer Smartphone-Enabled COVID-19 Tests Nationwide

by Jasmine Pennic 02/17/2021 Leave a Comment

Kroger Health to Offer Smartphone-Enabled COVID-19 Tests Nationwide

What You Should Know: - Kroger Health, the healthcare division of The Kroger Co. announced plans to offer the first smartphone-enabled, at-home Gauss COVID-19 Rapid Antigen Test Kit to patients nationwide, expanding the company's existing portfolio of in-clinic and employer-focused COVID-19 testing solutions. - Kroger Health expects the at-home rapid antigen test will be available to purchase on Kroger.com and over the counter at its 2,200 pharmacies nationwide. The test, developed by
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Healthcare UX- How Can We Optimize Adoption for Patients & Doctors?

by Fred Pennic 02/16/2021 Leave a Comment

UX & Testing in Healthcare - How Can We Ensure Tech Adoption for All?

Due to the pandemic, recent FDA guidance acknowledges that companies conducting trials may require to put new processes in place regarding their current protocols considering virtual patients, data management, and usability. This raises the question: How to ensure and optimize user experience (UX) for patients and doctors with faster digital health adoption?  We recently spoke with Facundo Navarro, Engagement Manager at intive, a digital transformation firm
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ECRI Institute: Top 10 Health Technology Hazards to Watch in 2021

by Fred Pennic 02/16/2021 Leave a Comment

ECRI Institute: Top 10 Health Technology Hazards to Watch in 2021

What You Should Know: - ECRI Institute identified the complexity of managing medical devices with COVID-19 emergency use authorization as the number one technology hazard in its Top 10 Health Technology Hazards for 2021 report. ECRI Institute’s Top 10 Health Technology Hazards, now in its 14th year, identifies top health technology concerns that warrant attention from healthcare leaders. The hazards selected are based on a rigorous review of ECRI’s incident
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Highmark BCBS Expands Access to Freespira’s Digital Therapeutic to Help Treat PTSD, Panic Attacks

by Jasmine Pennic 02/03/2021 Leave a Comment

Freespira Secures $10M for FDA-Cleared Digital Therapeutic to Eliminate Panic Attacks, PTSD Symptoms

What You Should Know: - Health insurer Highmark expands access to FDA-cleared digital therapeutic Freespira proven to reduce the symptoms of panic disorder and PTSD for members in Pennsylvania, Delaware and Virginia. - The announcement follows a pilot study finding that nearly 9 out of 10 patients using the solution were symptom-free after treatment. Highmark Inc., the fourth-largest Blue Cross Blue Shield-affiliated organization announced it is expanding access to Freespira’s
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Casana Raises $14M to Expand IoT Heart Health Toilet Seat

by Fred Pennic 02/03/2021 Leave a Comment

Casana Raises $14 Million for In-home Heart Health Monitoring Device

What You Should Know: - Casana raises $14M in Series A funding to pursue FDA clearance for its an IoT heart health toilet seat that captures clinically relevant measurements, including heart rate, blood pressure, blood oxygenation, and cardiac output. Casana, previously known as Heart Health Intelligence, Inc., a healthcare technology firm that is re-inventing in-home health monitoring, today announced that it has raised $14M in Series A funding, bringing the total capital raised to
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Syapse Lands $68M to Expand Global Precision Oncology Data Sharing Network

by Fred Pennic 02/02/2021 Leave a Comment

FDA, Syapse Expand Research to Generate Real-World Data Related to COVID-19 and Cancer

What You Should Know: - Syapse raises 68M in equity investment  led by Ally Bridge Group (ABG), with Northpond Ventures to expand delivery of real-world evidence  through Syapse’s Learning Health Network. - The Syapse Learning Health Network is a global precision oncology data sharing network, improving cancer care across communities by using real-world data to support clinical decisions. Syapse, a San Francisco, CA-based real-world evidence company accelerating the delivery
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SWORD Health Nabs $25M for Virtual Musculoskeletal Care Solution

by Jasmine Pennic 02/01/2021 Leave a Comment

SWORD Health Nabs $25M for Virtual Musculoskeletal Care Solution

What You Should Know: - SWORD Health raises $25 million in Series B to accelerate growth of its best-in-class virtual musculoskeletal care solution led by Todd Cozzens, Managing Partner at Transformation Capital and former healthcare investor at Sequoia Capital. Existing investors Khosla Ventures, Founders Fund, Green Innovations, Vesalius Biocapital and Faber also participated. The latest round brings SWORD’s cumulative fundraising to $50 million. - SWORD Health pairs licensed physical
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Tyto Care Launches FDA-Cleared Fingertip Pulse Oximeter Medical Device

by Jasmine Pennic 01/20/2021 Leave a Comment

COVID-19 Spikes Deaconess Health Adoption of Remote Medical Exams

What You Should Know: - Tyto Care announces the launch of its fingertip Pulse Oximeter device, allowing users to measure their own blood oxygen saturation level and heart rate from the comfort and safety of home. - Expanding its clinic-quality remote capabilities, TytoCare users will be able to perform a remote blood oxygen exam, allowing clinicians to better monitor patients with COVID-19 and chronic lung or heart conditions.  Tyto Care, a New York City-based all-in-one modular
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Biobeat Launches Home-Based Remote Patient Monitoring Kit

by Fred Pennic 01/20/2021 Leave a Comment

Biobeat Launches Home-Based Remote Patient Monitoring Kit

What You Should Know: - Today, Biobeat, developer of AI-powered remote patient monitoring solutions, announced the launch of its home patient monitoring kit. - The kit, which includes chest-monitors, compatible adhesive units, and a user-friendly manual, allows healthcare providers to bring hospital-level care to patient homes by empowering health staff and patients with proven wearable AI-powered remote patient monitoring technology. Biobeat, an Israeli-based continuous remote
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