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4 Steps for Operationalizing the FDA’s Call To Improve Health Outcomes for All Patients

HIT Consultant

In April, FDA Commissioner Dr. Robert Califf laid out areas of challenge and opportunity when it comes to improving health outcomes, restoring public trust in science, and making the most of our ongoing investments in data analytics and clinical research. Wang, Chief Medical Officer of COTA, Inc.

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

HIT Consultant

– 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 Tyto Insights for Wheeze Detection already bears the CE Mark for usage by clinicians in Europe.

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French Startup Awarded FDA Clearance for AI-Driven Prenatal Ultrasounds

HIT Consultant

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.

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15-Second Heart Failure Test: Eko’s AI Stethoscope Gets FDA Nod

HIT Consultant

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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The FDA Releases New Draft Guidance on Considering Health Care Disparities When Reviewing Proposed Devices

C&M Health Law

Food and Drug Administration (FDA) released a draft guidance that, if finalized, will update the agency’s 2018 guidance on its Breakthrough Devices Program (the “Program”).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.

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How Will New FDA Hearing Aid Regulations Impact Health Plans?

HIT Consultant

First, let’s examine the new regulatory framework the FDA established. Health plans offering the OTC benefit can also leverage the opportunity to educate members about the significant role hearing aids can play in improving their overall health. – What new opportunities will arise? Introducing OTC hearing aids.

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Cercle Launches AI-Powered Biomedical Graph for Fertility & Women’s Healthcare

HIT Consultant

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.