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

Inato Raises $20M to Make Clinical Trials More Inclusive

by Fred Pennic 03/29/2023 Leave a Comment

Inato Raises $20M to Make Clinical Trials More Inclusive

What You Should Know: - Inato, a technology platform that connects pharma companies (trial sponsors) with community-based trial sites raises $20M in new funding (A2) led by Cathay Innovation with participation from existing investor Obvious Ventures and new investors La Maison and Top Harvest Capital. Inato works with many of the top 30 pharmaceutical companies worldwide to make clinical trials more inclusive. - The new funding will fuel Inato’s continued product innovation, international
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Exec Hires: Elucid Appoints Andrew Miller as CTO

by Digital Health Executive Appointments 03/29/2023 Leave a Comment

Exec Hires: Elucid Appoints Andrew Miller as CTO

What You Should Know: - Elucid, Inc., a medical technology company providing physicians with AI-powered imaging analysis software to assess cardiovascular disease, has hired Andrew Miller as its chief technology officer (CTO). - As CTO, Andrew will lead the technology strategy and oversee the engineering team’s execution. Elucid’s software is the only FDA-cleared non-invasive tool able to accurately characterize arterial plaque, simulating what pathologists would see under a microscope and
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 Are Hospitals Ready for Alzheimer’s Treatment Approval?

by John Showalter, MD, Chief Product Officer at Linus Health 03/20/2023 Leave a Comment

 Are Hospitals Ready for Alzheimer's Treatment Approval?

The FDA’s recent accelerated approval of Leqembi was welcome news across the Alzheimer’s community. However, few health systems, medical practices, or providers are prepared for the extraordinary public interest in a treatment for Alzheimer’s disease – especially not one targeting mild cognitive impairment (MCI) and early dementia due to Alzheimer’s disease – that is likely headed their way soon. The unprecedented scale of the public health and marketing campaigns, the high prevalence of MCI in
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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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