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

TytoCare Receives FDA Clearance for AI-Powered Tyto Insights for Wheeze Detection

by Syed Hamza Sohail 03/15/2023 Leave a Comment

TytoCare and Overlake Partner to Expand Virtual Care Offerings

- TytoCare, a virtual care company enabling accessible, high-quality primary care from home, today announced that it received FDA clearance for its Tyto Insights for Wheeze Detection, paving the way for its rollout in the US. - The wheeze detection algorithm expands the company’s existing AI-powered Tyto Insights™ smart diagnostic capabilities, filling the quality gaps currently experienced with traditional telehealth and alleviating challenges imposed by the ongoing shortage of healthcare
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H1 Launches Advanced Diversity and Clinical Trial Performance Insights

by Syed Hamza Sohail 03/13/2023 Leave a Comment

H1 Launches Advanced Diversity and Clinical Trial Performance Insights

What You Should Know: - H1, the connecting force for global healthcare provider, clinical, science, and research information, today announced the availability of indication-level diversity insights in addition to institution, provider, and patient diversity data within its Trial Landscape solution. - Additionally, H1 has successfully onboarded its first customer – a top 20 pharmaceutical company – onto the H1 Data Network, a new solution that aggregates sponsor-contributed site and
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National Kidney Foundation and Healthy.io Partner on Kidney Disease Detection

by Jasmine Pennic 03/09/2023 Leave a Comment

Omada Health, Intermountain, Castell to Establish Integrated, Virtual Care Option for Diabetes Management and Prevention

What You Should Know: - The National Kidney Foundation (NKF), a non-profit health organization and Healthy.io, a global leader in transforming the smartphone camera into a clinical-grade medical device, announced a new effort to promote the detection of chronic kidney disease (CKD). - Through their partnership, the NKF and Healthy.io will offer Healthy.io's Minuteful Kidney™ at-home kidney test, free of charge, to people who are at risk for kidney disease. Healthy.io's Minuteful Kidney
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Portfolia Invests in Xandar Kardian for Health Monitoring

by Fred Pennic 02/27/2023 Leave a Comment

Portfolia Invests in Xandar Kardian for Health Monitoring

What You Should Know: - Portfolia, the world’s most powerful community of women investors, has officially announced a significant investment in Xandar Kardian from the firm’s Active Aging I and Active Aging II funds. Portfolia’s investment represents a core contribution to Xandar Kardian’s $10 million Series A Funding round. - Portfolia sees Xandar Kardian’s impact extends well beyond the traditional hospital room, with impressive potential growth opportunities into a wider
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Eko Launches Cardiac Disease Detection Platform, SENSORA

by Fred Pennic 02/23/2023 Leave a Comment

Eko Launches Cardiac Disease Detection Platform

What You Should Know: - Eko, a digital health company applying artificial intelligence (AI) in the fight against heart and lung disease launches the SENSORA™ Cardiac Disease Detection Platform. - SENSORA™ currently features AI that objectively identifies structural murmurs, a sign of valvular heart disease, and Care Pathway Analytics software that provides downstream visibility and metrics of the patient journey through the healthcare system. Eko SENSORA Cardiac Disease Detection
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Bicycle Health, Wellpath to Provide Opioid Use Disorder Treatment to Federal Bureau of Prisons

by Fred Pennic 02/23/2023 Leave a Comment

Bicycle Health, Wellpath to Provide Opioid Use Disorder Treatment to Federal Bureau of Prisons

What You Should Know: - Bicycle Health, a telehealth provider of integrated medical and behavioral health treatment for opioid use disorder (OUD) is teaming up with Wellpath, the premier provider of localized, compassionate care to vulnerable patients in challenging clinical environments, and the Federal Bureau of Prisons (FBOP). - The collaboration will enable patients to access Bicycle Health’s evidence-based, life-saving clinical care model delivering virtual Medication for
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Addressing the Diversity Challenge in Clinical Research Through Patient Advocacy

by Andrew Barnhill, Head of Public Policy, Global Legal, IQVIA & Alexandra Weiss, Director of Strategic Partnerships, Patient Advocacy Organizations, IQVIA 02/23/2023 Leave a Comment

Addressing the Diversity Challenge in Clinical Research Through Patient Advocacy

Diversity is paramount to the success of clinical research, both ethically and scientifically. Without adequate representation of racial and ethnic minorities, investigators lack an understanding of the safety and efficacy of novel treatments within those groups. From a scientific standpoint, an incomplete dataset hinders drug delivery and the development of breakthrough therapies – but from an ethical standpoint, underrepresentation creates a barrier to treatment options for populations that
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5 Components of a Patient-Centric eCOA Strategy for Oncology Clinical Trials

by Melissa Mooney, Director of eCOA Solutions Engineering at IQVIA 02/20/2023 Leave a Comment

Amplifying the Patient Voice in Oncology Clinical Trials

In the US alone, an estimated 1.9 million new cases of cancer were diagnosed in 2022, positioning oncology as a key subject of clinical research. Throughout oncology trial development, it is important that stakeholders acknowledge that only patients can fully understand the impact of treatment on their lives. Regulators are now looking beyond clinical indications such as tumor size and delayed disease progression. When evaluating the risks and benefits of treatment, they want to know whether the
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HTA to Offer Cognoa’s Canvas Dx Diagnostic Device for Autism to Member Organizations

by Syed Hamza Sohail 02/16/2023 Leave a Comment

HTA to Offer Cognoa’s Canvas Dx Diagnostic Device for Autism to Member Organizations

What You Should Know: - Health Transformation Alliance (HTA), a cooperative of nearly 60 of America’s largest employers, has partnered with Cognoa, a pediatric behavioral health company, to offer the company’s Canvas Dx diagnostic device for autism to all HTA Member organizations and their employees. - HTA will offer its member organizations – some of the most influential and significant brands in the U.S. – the opportunity to add Canvas Dx to their benefit design. Expanding Horizons By
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FemTech: Samsung Adds Menstrual Cycle Tracking Capabilities to Galaxy Watch5

by Jasmine Pennic 02/14/2023 Leave a Comment

FemTech: Samsung Adds Menstrual Cycle Tracking Capabilities to Galaxy Watch5

What You Should Know: - Samsung Galaxy Watch5 users will soon be able to access temperature-based menstrual cycle tracking through the Cycle Tracking feature. This new capability was developed in partnership with Natural Cycles, a women’s health company and app maker, and marks the first time Natural Cycles’ algorithm has been adapted for a smartwatch. - The partnership combines Natural Cycles’ fertility technology with Samsung’s BioActive Sensor to give users more detailed
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