Kaiser Health News

OCTOBER 7, 2024

senators have pressed the FDA to take steps to eliminate pulse oximetry’s racial bias, which has caused delays in treatment and worse health outcomes, and more recently has raised concern about the reliability of hospital AI tools that draw on reams of data from the devices. . The FDA’s response was modest.

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FDA Doctors Hospitals Health Outcomes 129

Bill of Health

OCTOBER 30, 2024

The lawsuits, arising from the desire to hold platforms accountable for exploiting children’s susceptibility to rewarding stimuli during development, present a novel theory of liability based solely on an algorithm’s ability to cause addiction rather than adverse mental health outcomes.

FDA 100

FDA Health Outcomes Public Health Governance 100

Healthcare IT News - Telehealth

MARCH 14, 2022

The virtual caregiver is designed to engage with and help monitor the health of aging, chronically ill and child patients via touchscreen devices placed throughout a residence. Individual patients can purchase "Flow Health" for $599. "Addison is a.

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FDA Doctors Telemedicine Health Outcomes 148

Healthcare IT News - Telehealth

AUGUST 6, 2024

UpScriptHealth also works with other medical device companies to increase access – for example, it powers telehealth consultations for Spark Biomedical's Sparrow Ascent, the only FDA-cleared, drug-free, non-addictive, non-invasive, wearable treatment technology for the relief of opioid withdrawal symptoms.

Telemedicine 153

Telemedicine FDA HIPAA Licensing 153

HIT Consultant

JULY 24, 2024

What You Should Know: – SoundHealth , a medical technology company focused on harnessing AI for better health outcomes, has launched SONU , the world’s first FDA-cleared AI-powered wearable for treating moderate to severe nasal congestion.

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FDA Health Outcomes Doctors 52

C&M Health Law

NOVEMBER 3, 2022

Food and Drug Administration (FDA) released a draft guidance that, if finalized, will update the agency’s 2018 guidance on its Breakthrough Devices Program (the “Program”). To address health disparities, FDA proposes adding new section III.B.3.d On October 21st, the U.S.

FDA 52

FDA Health Outcomes Public Health 52

HIT Consultant

AUGUST 2, 2023

What You Should Know: Sonio, the artificial intelligence company revolutionizing fetal ultrasounds, announced today that their proprietary approach to ultrasound exams on pregnant people has now been recognized in the United States as a product that meets health performance and safety standards.

FDA 52

FDA Health Outcomes 52

HIT Consultant

FEBRUARY 11, 2025

By eliminating the need for wearables, its FDA-listed technology provides lab-quality gait and motion analysis in seconds, enabling healthcare providers to assess, treat, and monitor patients remotely. “This partnership ensures senior living communities can leverage cutting-edge technology to support better health outcomes.”

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FDA Health Outcomes Nurses 52

HIT Consultant

DECEMBER 1, 2022

AutoZone’s Health Outcomes for Employees. – Clinically Significant Weight Loss: Across all groups, patients saw at least 8% weight loss on average (5% is the benchmark for FDA-approved weight-loss drugs and what is considered clinically significant).

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FDA Health Outcomes 98

Healthcare IT News - Telehealth

JANUARY 23, 2024

Sean Brady, CEO and cofounder of Ventric Health, is doing his part to turn this problem around. He is head of the team behind a newly FDA-cleared cardiac device designed to help manage the challenges around heart failure. Please describe your newly FDA-cleared cardiac device for heart failure and discuss how it works.

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FDA Medicare Medicare Hospitals 197

HIT Consultant

NOVEMBER 8, 2023

These data insights can accelerate medical discoveries in the pharmaceutical and research fields, enable the acceleration of precision medicine and personalized treatments, help clinics improve the efficiency and effectiveness of medical care, and ultimately, drive better health outcomes.

Health Outcomes 111

Health Outcomes FDA 111

Healthcare IT Today

FEBRUARY 29, 2024

The participant’s digital twin forecasts their health outcomes under placebo, regardless of their actual assignment. TwinRCTs reduce the time it takes to bring new drugs and therapies to market, ultimately paving the way for improved health outcomes for all. Founder and CEO at Unlearn. or follow us on X and LinkedIn.

Pharmaceutical Industry 128

Pharmaceutical Industry Health Outcomes FDA 128

HIT Consultant

DECEMBER 14, 2021

Xandar Kardian’s XK300 Autonomous Health Monitoring Solution is the world’s first and only commercially available, contact-free, continuous VSM (vital sign monitoring) system that is FDA 510(k) cleared as a class II medical device.

FDA 98

FDA Health Outcomes Doctors Nurses 98

HIT Consultant

SEPTEMBER 20, 2022

PH affects up to 1% of the global population and is a marker of poor health outcomes.¹ Pulmonary hypertension is a severe condition that occurs when the pressure in the vessels that carry blood from the heart to the lungs is higher than normal, causing undo stress on the heart. A previous $2.7M

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FDA Health Outcomes 96

HIT Consultant

NOVEMBER 14, 2024

Another study in Frontiers highlighted the potential of mobile health solutions in low- and middle-income countries to enhance patient treatment and rehabilitation by providing low-cost, accessible healthcare through smartphones, tablets, wearable sensors, mobile applications, and telemedicine platforms.

ADA 98

ADA Doctors Telemedicine FDA 98

Healthcare IT News - Telehealth

FEBRUARY 6, 2024

By using them, providers can enhance patient engagement, allowing for personalized and proactive care management that drives better health outcomes and better care experiences. Connected care at-home technologies enable behavior change and empower individuals and clinicians to make informed decisions about healthcare treatment.

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Nurses Telemedicine FDA Health Outcomes 198

Health Populi

OCTOBER 6, 2021

Abbott and others in their core business space of pharma, specialty medicines, and medical devices are now part of the expanding digital therapeutics world that marries software to medical goods – whether a pill or device – to bolster health outcomes, adherence, and quality.

COVID-19 147

COVID-19 FDA Health Outcomes Doctors 147

HIT Consultant

AUGUST 22, 2024

OneStep: Revolutionizing Remote Physical Therapy with Smartphone-Based Gait and Motion Analysis OneStep leverages smartphone motion sensors to provide continuous, clinically-validated gait and motion analysis in real-life conditions without the need for wearables.

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Regulatory Compliance FDA Compliance Health Outcomes 98

HIT Consultant

JUNE 5, 2024

It combines TytoCare’s FDA-cleared handheld remote examination device, which performs heart, lung, throat, ear, and body temperature exams, with Tyto Insights™ clinical decision support software and Tyto Engagement Labs™.

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FDA Health Outcomes 115

HIT Consultant

MARCH 10, 2022

a precision medicine company, announced a venture investment from PACE Healthcare Capital , an early-stage investment firm committed to improving health outcomes. Prenosis is currently seeking to obtain FDA clearance for the tool by the end of 2022. What You Should Know: – Prenosis, Inc.,

Electronic Medical Records 98

Electronic Medical Records FDA Hospitals Health Outcomes 98

HIT Consultant

MAY 2, 2022

Although it is well established that diversity improves outcomes and drives excellence, implementing diversity lags behind in many industries, including life sciences and healthcare. experience significant health disparities , including higher rates of chronic disease and premature death compared to the white population.

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COVID-19 Vaccine COVID-19 Patient Advocacy Pharmaceutical Industry 98

HIT Consultant

OCTOBER 17, 2021

Since DTx plays such a substantive role in the therapeutic process, these apps must meet the same standards of clinical evidence required by the FDA and other regulatory agencies for approval of conventional medical treatments. FDA website, March 27, 2018. – The richness and size of the real-world datasets.

FDA 98

FDA Health Outcomes Doctors Hospitals 98

HIT Consultant

JUNE 16, 2022

While hospitals have the money and resources to use a variety of Federal Drug Administration-approved sensors and instruments to gain a holistic view of the necessary health data and deliver the best possible care for patients, the consumer care marketplace is not yet that advanced. Compliance.

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FDA Compliance Hospitals Health Outcomes 98

HIT Consultant

FEBRUARY 8, 2024

Their innovative approach uses digital twins, AI-generated models that predict individual patient health outcomes under different treatment scenarios. AI-Powered Clinical Trials with Digital Twins Founded in 2017, Unlearn has consistently pushed the boundaries of AI in clinical research. founder and CEO of Unlearn.

Regulatory Compliance 97

Regulatory Compliance FDA Health Outcomes Compliance 97

Healthcare Law Today

FEBRUARY 1, 2022

Fund grant opportunities to state, local, or tribal health departments, community-based organizations, Indian organizations, or other public or private entities for projects that would improve health outcomes and reduce health disparities. Senators Murray and Burr expect the legislation to progress this year.

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COVID-19 FDA Public Health Health Services Administration 98

HIT Consultant

APRIL 12, 2023

The beauty here is that once an app has detected a condition, users are then able to take guided action to improve health outcomes and lower their risks. Several factors play a part in this, from the need for FDA clearance to general user error. Unfortunately, most health apps are currently not regulated.

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Doctors FDA Health Outcomes 98

HIT Consultant

APRIL 2, 2024

What You Should Know: – Eko Health , a provider of AI-powered heart and lung disease detection today announced FDA clearance for its Low EF detection AI. – Built in collaboration with Mayo Clinic, the AI allows U.S.

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FDA Health Outcomes 40

Healthcare IT News - Telehealth

MAY 6, 2020

The platform has embedded video conferencing, or works alongside the video conferencing platform a health system has in place. It also equips providers with Eko’s FDA-cleared AI to assist in remote screening for AFib, heart murmurs, tachycardia and bradycardia. Vivify Health. iRhythm Technologies.

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COVID-19 FDA Hospitals Elder Care 217

Health Populi

DECEMBER 27, 2021

That a pharmaceutical company executive is speaking on the main stage at CES speaks to digital health’s mainstreaming beyond elite athletes and smartwatches that track activity. Other forces on the demand side of health/care converge with this supply side to make the market for tech-enabled, consumer-facing health care.

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COVID-19 FDA Health Outcomes Doctors 162

HIT Consultant

SEPTEMBER 16, 2022

The ultimate goal is to develop innovative clinical trials that yield medical breakthroughs to improve preventive care and health outcomes for patients. One trial is evaluating an FDA-approved remote robotic ultrasound system to effectively capture expert quality cardiac ultrasound images remotely. Current Clinical Trials.

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FDA Hospitals Health Outcomes 98

HIT Consultant

OCTOBER 21, 2021

Zerigo Health’s FDA-cleared, natural light therapy solution safely and effectively shifts dermatological care from the clinic to the controlled convenience of home, keeping physicians and their patients with chronic skin conditions connected with personalized data and insights.

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FDA Health Outcomes 98

HIT Consultant

JANUARY 24, 2025

Food and Drug Administration (FDA). As healthcare systems implement AI tools thoughtfully and securely, they create opportunities for stronger connections between clinicians and patients, leading to restored trust in medical care and improved health outcomes. AI implementation must be systematic and thoughtful.

COVID-19 52

COVID-19 Doctors FDA Health Outcomes 52

HIT Consultant

OCTOBER 30, 2024

Leveraging TytoCare’s FDA-cleared, AI-powered lung and wheeze detection, these exams replicate the quality of in-person clinic visits, providing vital health services without requiring physical presence at medical facilities.

Nurses 97

Nurses FDA Health Outcomes Hospitals 97

Healthcare IT Today

JANUARY 15, 2024

“That’s why we’ve developed a first-of-its-kind metabolic health program specifically designed for adolescents. Our goal is to encourage and set behavioral and lifestyle changes that will lead to healthier habits and better long-term outcomes.” In fact, a 2022 clinical trial found a 16.1 To learn more, visit knownwell.co.

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FDA Health Outcomes 122

Kaiser Permanente

JANUARY 21, 2022

Although marketing a drug prior to FDA approval is illegal, marketing a disease is not; in fact, disease mongering for a specific drug starts years before the treatment is expected to be approved. The post How pharmaceutical marketing affects decisions about patient care appeared first on Kaiser Permanente Institute for Health Policy.

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Pharmaceutical Industry FDA Health Outcomes 98

Healthcare IT Today

DECEMBER 30, 2024

This shift, driven by the FDA’s Diversity Action Plans, will accelerate trial enrollment, improve representation, and ultimately enhance patient safety by ensuring more diverse data in research. These networks ensure employees can receive top-tier care regardless of location, enhancing satisfaction and improving health outcomes.

US Department of Health and Human Services 91

US Department of Health and Human Services Nurses Medicare Medicare 91

HIT Consultant

DECEMBER 28, 2021

The ability to accurately and reliably leverage the massive amount of data that is routinely collected throughout the healthcare arena and use it to amplify the clinical findings of the randomized clinical trial creates enormous opportunities for improved prescribing and improved health outcomes for patients.

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Health Outcomes FDA Hospitals 98